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Effect of a mother-baby delivery pack on institutional deliveries: A community intervention trial to address maternal mortality in rural Zambia
2
,* Fionnuala M. McAuliffe, Writing – review & editing,
3
Olusegun Babaniyi, Writing – review & editing,
4
Sarai Malumo, Writing – review & editing,
4
Joseph Phiri, Writing – review & editing,
5
and Patricia Fitzpatrick, Methodology, Writing – review & editing
6
Abstract
Objectives
To test the effect of providing additional health education during antenatal care (ANC) and a mother-baby delivery pack on institutional deliveries in Monze, Zambia.
Setting
16 primary health facilities conducting deliveries in the district.
Participant
A total of 5000 pregnant women at any gestation and age attending antenatal care (ANC) services in selected health facilities were eligible for enrolment into the study. Out of these, 4,500 (90%) were enrolled into and completed the study. A total of 3,882 (77.6%) were included in the analysis; 12.4% were not included in the analysis due to incomplete data.
Intervention
A three-year study (2012 to 2014) analysing baseline delivery data for 2012 and 2013 followed by a community intervention trial was conducted from January to December 2014. Health facilities on the western side were assigned to the intervention arm; those on the eastern side were in the control. In addition to the health education provided during routine ANC visits, participants in the intervention arm received health education and a mother-baby delivery pack when they arrived at the health facility for delivery. Participants in the control arm continued with routine ANC services.
Outcome measures
The primary measure was the number of institutional deliveries in both arms over the one-year period. Secondary measures were utilisation of ANC, post-natal care (PNC) and under-five clinic services. Descriptive statistics (frequencies, proportions, means and standard deviation) were computed to summarise participant characteristics. Chi-square and Independent T-tests were used to make comparisons between the two arms. One way analysis of variance (ANOVA) was used to test the effect of the intervention after one year (p-value<0.05). Analysis was conducted using R-studio statistical software version 4.2.1. The p-value<0.05 was considered significant.
Results
Analysis showed a 15.9% increase in the number of institutional deliveries and a significant difference in the mean number of deliveries between intervention and control arms after one year (F(1,46) = 18.85, p<0.001). Post hoc analysis showed a significant difference in the mean number of deliveries between the intervention and control arms for 2014 (p<0.001). Compared to the control arm, participants in the intervention arm returned earlier for PNC clinic visit, brought their children back and started the under-five clinic visits earlier.
Conclusion
These findings provide evidence for the effectiveness of the mother-baby delivery pack and additional health education sessions on increasing institutional deliveries, PNC and under-five children’s clinic utilisation in rural Zambia.
Trial registration
ISRCTN Registry (ISRCTN15439813 DOI 10.1186/ISRCTN15439813); Pan African Clinical Trial Registry (PACTR202212611709509).
Introduction
Background
Globally, approximately 830 women die every day from preventable causes related to pregnancy and childbirth [1, 2]. Most (99%) maternal deaths occur in developing countries, especially among women living in rural areas and among poorer communities [1, 2]. Zambia is one of the developing countries with a high maternal mortality ratio (MMR) [3, 4]—one of the highest in the world. The latest Demographic and Health Survey (DHS) [4] reported a high MMR of 252 per 100 000 live births in the country. Various factors including home deliveries and limited access to institutional deliveries have been shown to contribute to high MMR [5].
To improve maternal and newborn health outcomes, the Zambian Ministry of Health (MoH) has been implementing several life-saving interventions, including focused antenatal care (FANC) services [6, 7]. The national maternal health service guidelines recommend that pregnant women go for FANC visits at the health facility as soon as they realize they are pregnant and that they have at least four FANC visits [8]. The recommended FANC visit schedule prescribes that the first visit should occur by the end of 12 weeks of pregnancy, the second at 24 weeks, the third at 32 weeks, and the fourth at 36 weeks of pregnancy. However, women who experience discomfort, danger signs or have special needs or conditions beyond the scope of basic care may require additional visits [8]. Regular and prompt FANC is helpful to identify and prevent adverse pregnancy outcomes when it is sought early in pregnancy and is continued through delivery [9, 10].
FANC provides pregnant women with access to health messages and interventions for prevention and treatment of various diseases such as malaria in pregnancy, anaemia, and sexually transmitted infections (STIs) and HIV. The main services offered to pregnant women during FANC visits include HIV counselling, testing and treatment to prevent transmission of the virus to the unborn baby. Pregnant women are also tested and treated for syphilis, malaria, anaemia and hypertension in pregnancy. Moreover, women are offered health messages on nutrition, anaemia and birth preparedness. Other services include disease prevention against malaria and anaemia, through prophylaxis, micronutrient supplementation, immunization, provision of long-lasting insecticide nets (LLINs), and disease screening to ensure early detection of complications and prompt treatment. In addition, women are advised on birth preparedness and complication readiness [11].
Other interventions are delivery under supervision by a skilled birth attendant and postnatal care (PNC). The World Health Organisation (WHO) defines PNC as the care provided to the mother and her new-born child immediately after birth of the placenta and for the first six weeks (42 days) postpartum [12]. Prompt and quality PNC is a critical phase in the lives of mothers and newborns [13] for both the prevention and treatment of complications arising from pregnancy and delivery. PNC has the potential to avert a substantial proportion of maternal and perinatal mortality and morbidity. It also provides the mother with important information on family planning, well-baby care, umbilical cord care, HIV and malaria prevention, and infant nutrition [14]. Since 2014, Zambia has been implementing the new PNC guidelines which seek to address the timing, number, and place of postnatal contacts, and content of PNC for all mothers and babies during the six weeks postpartum. After an uncomplicated vaginal delivery in a health facility by a skilled birth attendant, which is strongly recommended by the WHO, women and their new-borns are advised to remain within the health facility for a minimum of 24 hours for observation of danger signs, and prevention and treatment of postpartum complications, such as excessive bleeding, raised blood pressure or eclampsia. Women who give birth at home are encouraged to visit the health facility within 24 hours postpartum. Subsequent visits are at day 2–3, day 7–14, and day 42 postpartum [14]. This changed previous guidelines which required women to remain in the hospital for a shorter period of 6 h postpartum and return to the health facility after 6 days and 6 weeks.
Despite maternal healthcare services being provided at little to no cost in most government-run health facilities in Zambia, a large proportion of women still give birth at home. The ZDHS shows that one third (33%) of rural women in Zambia deliver at home without skilled birth attendants. Limited access and socioeconomic factors have been shown to be the main reasons influencing people’s decision-making about utilisation of maternal healthcare services in developing countries, especially in rural areas [15]. Hidden costs incurred by expectant mothers when seeking maternal health care have been reported as important barriers to institutional deliveries. For instance, long distances and high poverty levels contribute to reduced access to health facilities. This is especially true for the 59% of Zambians living below the poverty datum line of one (1) US dollar per day [16]. Costs associated with seeking maternal healthcare include transportation, medications and supplies as well as the opportunity costs of travel and waiting time lost from productive activities [17]. It is common practice for health facilities to request expectant mothers to provide their own supplies for delivery. These supplies include clothing for both the mother and baby, baby blankets, napkins, baby soap and delivery materials such as gloves and disinfectant [18]. Embarrassment at not being able to afford these basic requirements presents another relevant barrier to seeking professional care at health facilities. Out-of-pocket financing of health facility delivery costs has been shown to have substantial repercussions on households and make families more vulnerable to impoverishment [19]. This cost is prohibitive in rural populations that often rely on subsistence farming for their livelihood [20]. Reducing these hidden costs may motivate pregnant women to deliver in health facilities under the supervision of skilled birth attendants and contribute to reduction of maternal mortality [20]. Skilled care before, during and after childbirth can save the lives of women and newborn babies. The World Health Organisation (WHO) has shown that institutional delivery by skilled birth attendants and quality PNC are the most important strategies to reduce MMR in developing countries [21–24].
Objectives
The primary objective of the study was to test the effect of providing additional health education during ANC and a mother-baby delivery pack on institutional deliveries in Monze, a rural district in Zambia. The mother-baby delivery pack included essential delivery supplies which would otherwise be an out-of-pocket expense for the mother. The secondary objective was to determine the effect of the intervention on ANC, PNC and under-five clinic utilisation by mother and baby. Evidence from the study is important for informing policy and interventions focusing on increasing institutional deliveries and improving maternal health outcomes.
Materials and methods
Trial design and randomisation
This was a three-year study (2012 to 2014) analysing baseline delivery data for 2012 and 2013 followed by one-year (1st January to 31st December, 2014) prospective community intervention trial conducted in Monze district, Zambia. Randomisation of study sites was done by the research team. First, the district was stratified into three (3) regions, namely, eastern, central and western regions. The central region was taken as a buffer zone separating the eastern and western regions. Next, by use of a coin flip, the western region was allocated to the intervention arm; the one on the eastern side as the control arm. A total of sixteen (16) health facilities were included in the study: eight (8) health facilities in each arm. A random sampling technique was used to select the 8 health centres from each arm. First, all the health centres in each arm were listed. The list served as a sampling frame. Next, information about delivery services at each health facility was obtained from the district health office. Health centres that did not conduct deliveries were removed from the list. A random number generator (RNG) was used to select the 8 health centres to be included in each arm. To be included, a health facility needed to have been conducting deliveries. The administrative centre of the district, with several urban health facilities, and two mission hospitals (Chikuni and Monze general) served as a physical separation and buffer between the intervention and control arms and prevented the spill over of relevant information on the intervention package. It was deemed unlikely for an expectant mother to by-pass the more than 30km buffer and go for delivery in the opposite arm. Both intervention and control regions had similar health facilities regarding the location (rural), size and catchment population, socio-economic and demographic profiles. The two regions mainly served peasant and subsistence farmers of the same tribe who shared the same cultural and traditional practices and beliefs. To ensure that the two regions were comparable regarding population size, population data for the two regions was obtained from the Central Statistical Office in Zambia [25].
Study participants and setting
Study participants were pregnant women from both the intervention and control sites in Monze district in the Southern Province of Zambia. At the time, the district had a population of 203,038 [25] with 26 health centres and 2 mission hospitals (Chikuni and Monze general) under the catholic church. All the health centres (except for five) provided maternal and child health services and conducted deliveries. In addition to general health services, both Chikuni and Monze general mission hospitals provided routine and emergency obstetric and newborn care in the district. Monze mission general hospital served as the main referral hospital for the whole district, performed caesarean sections and dealt with all complicated cases referred from the health centres. There were no private health facilities providing obstetric and newborn health care in the district. At the time of the study, more than 50% of deliveries in the district took place at home, outside the health facility [25].
To be included in the study, women needed to be:
- Of reproductive age (15 years and above). Assent was obtained from the parents or legal guardians for the participants who were aged below 18 years
- Pregnant at any gestation
- Residing in the study site catchment area for at least 3 months. Pregnant women who were new in the area were excluded from the study
- Willing to participate
Participant enrolment
Recruitment and enrolment of study participants was done by a pair of trained research assistants with support from the principal investigator. Study participants were identified and screened from the ANC clinics, when pregnant women went for their first ANC visit, regardless of the stage of their pregnancy (gestation). All pregnant women attending ANC from 1st January to 30th June 2014 were eligible to be enrolled into the study. Since the outcome of interest was place of delivery (institutional or home delivery), recruitment of study participants ended on 30th June 2014 to ensure that only women whose expected date of delivery (EDD) fell before 30th November 2014 were recruited into the study. This date would provide a one-month window for participants with prolonged gestation (beyond 40 weeks) to be followed up until their time of delivery, before the end of the study on 31st December 2014. It was expected that all participants would give birth within the follow up period and all the observations would be made; no participant was followed up after delivery.
Intervention
The intervention comprised the mother-baby delivery pack and additional health education sessions. In addition to the health education provided during routine ANC visits, pregnant women in the intervention arm were provided with additional health education sessions. The additional health education was delivered by the health facility midwives through one-to-one and group discussion sessions. The sessions covered various aspects including birth preparedness, danger signs of pregnancy and complications. In order to ensure that standard and uniform information was provided during the health education sessions, leaflets translated into the local language were prepared by the research team.
In addition to the health education sessions, pregnant women in the intervention sites received a free mother-baby delivery pack. The packs were kept at the health facility; women only received them if they went to deliver at the health facility. Information about the mother-baby delivery pack was provided during the additional health education sessions which pregnant women had when they went for ANC visits. During the sessions, pregnant women were also given detailed information on the content of the delivery pack which included two (2) baby napkins, a bottle of Vaseline®, baby soap, a pair of delivery gloves, a baby vest, a chitenge (wrapper) and an insecticide treated mosquito net (ITN)). The control arm continued to receive routine standard ANC services.
Outcomes
The primary outcome was the difference in the mean number of institutional deliveries between the intervention and control arms over a three-year period from 1st January 2012 to 31st December 2014. The secondary outcome measures were: 1) ANC service utilisation; 2) PNC service utilisation by mother and baby; 3) under-five clinic service utilisation. ANC, PNC and under-five service utilisation included the time of the first visit, number of visits completed according to the national guidelines. To measure ANC utilisation, the following information was collected: a) did the pregnant woman use ANC? b) what was the gestation at ANC booking? c) how many ANC visits did the pregnant woman make? Similarly, to operationalise PNC utilisation, the following information was collected: a) did the mother and her baby receive PNC? b) at what time after delivery were PNC services received? c) how many PNC visits did the mother-baby pair make? Similar questions were used to measure under-five clinic utilisation.
Sample size estimation
From the district total population of 203, 038 in 2013 [25, 26], we estimated the expected deliveries for the district (using the United Nations Inter-Agency Group (WHO, UNICEF, UNFPA, World Bank) formula [27], which Zambia and other developing countries have adopted for estimating deliveries based on the population) to be 10,964. These would be pregnant and need maternal health services during 2014 when the intervention was implemented. Allowing for 60% of the population living in the urban area of the district, along the trial buffer zone, we estimated our sample size to be 4,500, (that is, 3000 in the intervention arm and 1,500 in the control).
Data collection procedures
Data collection was done in two phases: baseline and intervention trial. To establish baseline delivery data prior to commencement of the intervention, year-long delivery records for 2012 and 2013 were reviewed and delivery data collected from the delivery registers at each health facility in the study sites, using a data extraction sheet. The data extraction sheet comprised various sections including demographics (age, place of residence), gravidity, parity, gestation, pre-existing medical conditions (hypertension, HIV, anaemia), expected date of delivery, date of delivery, place of delivery, mode of delivery, delivery outcome, baby condition and outcome. In addition, the PNC and under-five registers were reviewed to identify home deliveries. Next, the trial intervention data were collected from 1st January to 31st December 2014.
Both the baseline and intervention data were collected by a team of trained research assistants comprising a total of thirty-two (32) midwives working in pairs recruited from the health centres participating in the study. To avoid bias during data collection, several measures were taken. First, all the data collectors underwent a four (4) days training before commencement of data collection. The training was conducted by the principal investigator assisted by a member of the research team and comprised classroom-based theory for three (3) three days followed by a practical training for one (1) day. Topics covered during classroom training included: a) the purpose of the study, b) study methods including sampling techniques and selection criteria; d) ethical considerations, and e) questionnaire administration. During the one day practical, data collectors practised how to use the checklist to collect baseline data, obtain informed consent and administer the questionnaire for the prospective study data. The consent form, checklist and questionnaire were revised based on the feedback from the data collectors. In addition, data collectors were not involved in the provision of ANC, delivery and PNC services. To be effective and efficient, data collectors worked in pairs under the supervision of the principal investigator.
Prospective data were collected using a paper-based questionnaire administered at three-time points: at enrolment into the study during the first ANC clinic visit; in the labour ward when the woman came for delivery, after delivery and when the woman and baby came for the first PNC visit. Sections in the questionnaire included demographic, socioeconomic and maternal history, ANC utilisation, place of delivery, date of delivery and outcomes, PNC and under five children’s clinic utilisation.
Statistical methods
Data from the checklist and questionnaire were entered into an Excel sheet and saved on a password-protected computer. After cleaning up, data was transferred into R-studio statistical software version 4.2.1 for analysis. Descriptive statistics (frequencies, percentages, proportions, means and standard deviations) were used to summarise participant socio-demographic and clinical data as well as institutional deliveries in intervention and control areas for each year (2012, 2013 and 2014). Before analysing the data for the primary outcome measure, the means and proportions between the two groups were compared using the independent T-test and Chi-square tests. After establishing that there was no significant difference in the baseline characteristics between the two groups, one way analysis of variance (ANOVA) was used to test the difference in the mean number of institutional deliveries between the intervention and control sites during the three years (2012 to 2014) under investigation. First, the main ANOVA was used to determine the overall effect of the intervention on institutional deliveries. Next, post hoc analysis using Bonferroni correction for pairwise comparison was conducted to determine the mean number of institutional deliveries between the intervention and control sites during the baseline period (2012 & 2013) and after introduction of the intervention (2014). Pairwise comparison was also conducted to measure the difference in the mean number of institutional deliveries in the intervention sites between the baseline period (2012 & 2013) and after the intervention. To determine the differences in ANC, PNC and under-five children clinic utilisation between the two groups, tests of significance (unpaired t-test and Chi-square) were computed. The p-value<0.05 was considered significant.
Ethical statement
Ethical approval for the study was obtained from the tropical disease research centre (TDRC) ethics committee (TRC/ERC/04/09/2013). Authority to conduct the study was granted by the Ministry of Health, Zambia. Ethical exemption was obtained from University College Dublin, Ireland. Clinical trial registration was done with the ISRCTN registry (ISRCTN15439813 DOI 10.1186/ISRCTN15439813) and Pan African Clinical Trial Registry (PACTR202212611709509). In addition, we confirm that all methods were performed in accordance with the relevant guidelines regulating the consent to participate in a scientific study. Before participants were enrolled into the study, midwives confirmed the pregnancy status using the rapid gravid index test. Next, the purpose of the study was explained to the women. To ensure informed consent, before data collection, participants were given and asked to read the consent form (S1 File) which was translated into the local language. Data collectors read the consent form for those who could not read. The consent form provided information on the background and purpose of the study and the data collection process. It also contained a detailed description of the participants’ autonomy regarding their rights during the data collection process and the right to refuse or withdraw from the study. Potential benefits, risks and discomforts associated with the study were also explained. To make it easy for the participants to understand the consent form, research assistants explained every aspect in the language of the participants’ choosing. To make it easy for the participants to understand the consent form, research assistants explained every aspect; they also requested the participants to ask questions or seek clarification, if they had any, before commencing data collection. Next, participants willing to participate in the study were asked to provide written informed consent; those who could not read or write were asked to mark with an ‘X’. Individual informed consent was obtained from all the pregnant women during the first ANC visit before being enrolled into the study. After obtaining informed consent, the research assistants administered the questionnaire. In addition, in the case of minors, assent was obtained from guardians or parents. No further consent/assent was obtained at subsequent visits or data collection points.
Patient and public involvement
Study participants and the public were not directly involved in the design of the study. Rather, the intervention was designed in response to the hidden barriers to institutional deliveries identified and expressed by the end users in the community during a cross-sectional study conducted prior to this community intervention trial. However, selection of the primary health facilities and study participants was done in collaboration with stakeholders from the national, provincial, district and primary health facility and community levels. First, pre-field meetings were held with the national, provincial and managers to select primary health care facilities to be included in the study. Next, local district managers selected the primary health facilities to be included in the study. In turn, primary health care facility leaders and midwives in consultation with the principal investigator, recruited and enrolled the participants into the study. Finally, a report was written and shared with the funding organisation, Ministry of Health for dissemination of study findings.
Results
Participants
A total of 5,000 pregnant women were identified as eligible for enrolment into the study. Of these, 4,500 (90%) pregnant women were enrolled into and completed the study, out of whom 618 (12.36%) had incomplete records and were not included in the final analysis. A total final sample of 3,882 respondents (77.6%) were included in the final analysis, comprising 2,684 (69.1%) from the intervention arm and 1,198 (30.9%) from the control arm. A summary of the recruitment algorithm of study participants is shown in the supporting information (S1 Fig).
Demographic characteristics
Table 1 below shows the socio-demographic characteristics of the respondents from both the intervention and control arms. Most (83%) respondents were married with the majority (68.5%) having a gravidity of 1 to 3 at the time of recruitment. There was a significant difference in the median gravidity (p<0.001) between the respondents from the intervention arm (median = 3 pregnancies; IQR = 2.0, 4.0) and the control arm (median = 2 pregnancies; IQR = 1.0, 4.0). There was no significant difference (p = 0.224) in the mean age between the mothers in the intervention (mean = 24.6 years, SD = 6.8) and control arms (mean = 24.9 years, SD = 6.6). There was a notable difference in the number of children between the respondents from the intervention (mean = 3.6, SD = 2.3) and control arms (mean = 3.4, SD = 2.2); however the difference did not reach statistical significance level (p = 0.07). There was no significant difference (p = 0.21) in the mean gestational age at first ANC booking between the respondents in the intervention (mean = 5.4 months; SD = 2.3) and control arms (mean = 5.5 months; SD = 2.4).
Table 1
| Variable | Intervention (n = 2,386 | Control | Total | P- value |
|---|---|---|---|---|
| (n = 1,198) | (n = 3,584 | |||
| Age (years) Mean (SD) | 24.6 (6.8) | 24.9 (6.6) | 0.224 | |
| Number of children Mean (SD) | 3.6 (2.3) | 3.4(2.2) | 0.07 | |
| Marital status | 0.006 | |||
| Never married | 363 (15.2) | 105 (8.8) | 468 (13.1) | |
| Married | 1,952 (81.8) | 1,021 (85.2) | 2,973 (83.0) | |
| Cohabiting | 32 (1.3) | 42 (3.5) | 74 (2.1) | |
| Divorced | 21 (0.9) | 14 (1.2) | 35 (1.0) | |
| Separated | 11(0.5) | 11(0.9) | 22 (0.6) | |
| Widow | 7 (0.3) | 5 (0.4) | 12 (0.3) | |
| Gravidity, n (%) | 0.001* | |||
| 1 | 484 (20.3) | 341 (28.5) | 825 (23.0) | |
| 2–3 | 1,065 (44.6) | 567 (47.3) | 1,632 (45.5) | |
| 4–5 | 510 (21.4) | 201 (16.8) | 711 (19.8) | |
| +6 | 327 (13.7) | 89 (7.4) | 416 (11.6) | |
| Median (IQR) | 3.0 (2.0;4.0) | 2.0 (1.0;4.0) | 3.0 (2.0;4.0) | 0.001* |
| Antenatal booking (months) mean (SD) | 5.4 (.2.3) | 5.5 (2.4) | 0.21 |
Primary outcome: Deliveries in interventions and control arms
Table 2 below shows the number of home and health facility deliveries in the intervention and control sites from January 2012 to December 2014. There was a 15.9% significant increase in the number of institutional deliveries in the intervention arm from 40.3% in 2013 to 57.1% (p< 0·0001) at the end of the intervention in December 2014. No such increase was seen in the control arm; the percentage of institutional deliveries dropped from 44.8% in 2013 to 40.6% at the end of 2014. The number of institutional deliveries in the control sites over the three years are shown in Table 2 below. The birth rates remained similar in both intervention and control regions over the three-year period 2012 to 2014.
Table 2
| Year | Intervention Sites | |||
|---|---|---|---|---|
| Intervention | Control | Total | P-value | |
| 2012 | n = 4,074 | n = 2,814 | n = 6,888 | |
| Home | 2,394 (58.8) | 1,632 (58.0) | >0.05 | |
| Health Facility | 1,680 (41.2) | 1,182 (42.0) | ||
| 2013 | n = 4,154 | n = 2,950 | 7,104 | >0.05 |
| Home | 2,480 (59.7) | 1,628 (55.2) | ||
| Health Facility | 1,674 (40.3) | 1,322 (44.8) | ||
| 2014 | n = 4,197 | n = 2,990 | <0.0001 | |
| Home | 1,801 (42.9) | 1,776 (59.4) | ||
| Health Facility | 2,396 (57.1) | 1,214 (40.6) | ||
Analysis of variance (ANOVA) results
The main ANOVA showed a significant difference in the mean number of deliveries between the intervention and control arms at the end of the trial (F(1,46) = 18.85, p<0.001). Post hoc analysis showed a significant difference in the mean number of deliveries between the: a) intervention and control arms for 2014 (p<0.001); b) 2014 and the average baseline for 2012 and 2013 within the intervention arm (p = 0.014) and c) intervention arm in 2014 and control arm in 2013 (p<0.001). There was no significant difference between the intervention and control arms at baseline in 2012 and in 2013 (p>0.05). Table 3 below summarizes the ANOVA findings.
Table 3
| Year/Arm | P values for pairwise comparison | ||||
| 2012 Intervention | 2012 Control | 2013 Intervention | 2013 Control | 2014 Intervention | |
| 2012 Intervention | — | ||||
| 2012 Control | 1.00 | — | |||
| 2013 Intervention | 1.00 | 1.00 | — | ||
| 2013 Control | 0.56 | 1.00 | 0.16 | — | |
| 2014 Intervention | 0.048* | 0.0012** | 0.004* | 0.000066** | — |
| 2014 Control | 1.00 | 1.00 | 1.00 | 1.00 | 0.0017** |
Secondary outcome: ANC, PNC and under-five children’s clinic utilisation
Table 4 shows comparison in maternal health service utilization between the intervention and control arms.
Table 4
| Variable | Intervention (n = 2, 386) | Control (n = 1,198) | P-value |
|---|---|---|---|
| n (%)/ mean(sd) | n (%)/ mean(sd) | ||
| ANC attendance | 0.045 | ||
| Yes | 2,382 (99.8) | 1,197 (99.9) | |
| No | 4 (0.2) | 1 (0.1) | |
| First ANC booking (months) mean, sd | 4.7 (1.3) | 4.3 (1.1) | <0.001 |
| Number of ANC visits (mean (sd) | 3.2 (0.8) | 3.3 (0.8) | <0.001 |
| PNC | |||
| Yes | 2,344(98.2) | 1,158 (96.7) | 0.03 |
| no | 42 (1.8) | 40 (3.3) | |
| Timing of PNC (days), mean (sd) | 5.7 (0.9) | 7.8 (4.0) | <0.001 |
| Under five children’s clinic | <0.001 | ||
| Yes | 2, 158 (90.4) | 821 (68.5) | |
| No | 228 (9.6) | 377 (31.5) | |
| Timing of under five clinic attendance, mean (sd) | 30.4 (16.8) | 35.2 (14.1) | <0.001 |
ANC utilization
We performed the Fisher’s exact test to examine the association between ANC utilization and the intervention. The Fisher’s exact test was 0.67 and not significant (p>0.05). The unpaired t-test showed a significant difference between the intervention and control groups regarding the time when women went for the first ANC visit. On average, women in the control arm (mean = 4.3 months, SD = 1.1) started their ANC visits earlier than those in the intervention arm (mean = 4.7, SD = 1.3), (t(df = 3,482) = 9.13, p<0.001)). The test also showed a significant difference in the mean number of ANC visits between the intervention (mean = 3.2 visits, SD = 0.8) and the control groups (mean = 3.3 visits (0.8), (t(df = 3,482) = 3.53, p<0.001)).
PNC utilization
The chi-square test of independence showed a significant association between the intervention and PNC utilization, χ2(1, N = 3584) = 8.89, p = 0.03. In addition, the unpaired t-test showed a significant difference between the intervention and control groups regarding the time when women returned for the first PNC visit. On average, women in the intervention arm (mean = 5.7 days, SD = 0.9) returned earlier for their first PNC visit than those in the control arm (mean = 7.8, SD = 4.0), (t(df = 3,482) = 24.4, p<0.001)).
Under-five children’s clinic utilization
The chi-square test of independence showed a significant association between the intervention and under-five children’s clinic utilization, χ2(1, N = 3584) = 272.95, p<0.0001. The unpaired t-test showed a significant difference between the intervention and control groups regarding the time when women brought their babies for the first under- five children’s clinic visit. On average, women in the intervention arm (mean = 30.4 days, SD = 16.8) brought their babies earlier for their first under- five children than those in the control arm (mean = 35.2, SD = 14.1), (t(df = 3,482) = 8.5, p<0.001)).
Discussion
The objective of this study was to test the effect of providing additional health education during ANC and a mother-baby delivery pack on institutional deliveries in Monze, Zambia. Overall, at the end of the intervention, our findings showed a significant 15.9% increase in the number of institutional deliveries in the intervention arm compared to the average at baseline. No such increase was seen in the control arm; the percentage of institutional deliveries dropped from 44.8% in 2013 to 40.6% at the end of 2014. ANOVA showed a significant difference in the mean number of deliveries between intervention and control arms at the end of the trial. Compared to women in the control arm, participants in the intervention arm returned early for PNC and under-five children’s clinic visits.
These findings are consistent with previous studies which reported the importance of community-based interventions that focus on mitigating financial barriers in increasing facility-based deliveries [28–31]. A cluster randomised controlled trial measuring the impact of providing ‘mama kit’ incentives—small packages of childcare items provided to mothers conditional on delivering their baby in a facility in rural Zambia conducted by Wang and colleagues [31] reported a 63% statistically significant increase in facility delivery rates. Similarly, Akker and colleagues [32] reported a 78% increase in health facility deliveries following implementation of an intervention providing post-delivery packages consisting of one piece of soap, a baby blanket and a traditional wrap in Malawi. The study also reported that the increase was larger in peripheral rural facilities compared with the district hospital (94% vs. 38%) and concluded that mitigating financial barriers through provision of locally developed incentives can improve access to and utilization of professional maternity care in rural areas.
Moreover, our findings on the importance of financial barriers in preventing women from giving birth in health facilities are worth noting and corroborate previous studies [33–35]. For example, in their study on the reasons for home delivery and use of traditional birth attendants in rural Zambia, Sialubanje and colleagues [35] showed that, in addition to long distances, financial barriers including lack of money for baby clothes and other requirements prevent women from delivering at a clinic. These authors also showed that, although most pregnant women in rural Zambia have the intention to give birth in health facilities [36–38], many end up giving birth at home because they fail to provide the requirements asked by midwives at the health facility. To avoid being embarrassed, most pregnant women stay at home until delivery. They only go to the health facility for PNC and under- five children’s clinic. Similarly, a systematic review [39] by Banke-Thomas and others reported on the importance of contextual factors in determining utilisation of facility-based delivery services. These findings confirm the importance of mitigating socioeconomic barriers in increasing health facility deliveries in through community interventions that provide incentive such as the mother-baby delivery pack.
Although interventions providing incentives to mitigate financial barriers to service utilization mainly focus on women’s external motivation, previous studies have shown that such interventions have long term effects on women’s continued utilization of facility delivery services including PNC and under-five children’s clinic. For example, in their community health programme conducted in Narok County in Kenya, Kitui and colleagues [40] showed that such interventions had a significant impact on trends of facility deliveries over a 36-month period. Thus, such incentives have the potential to increase women’s intrinsic motivation to use maternal health services in the long term, even in the absence of incentives, especially when the intervention is accompanied with health promotion activities. Health promotion has been shown to help increase utilisation of maternal health care services, reduce excess mortality, address the leading risk factors and underlying determinants of health, and strengthen sustainable health systems [41–44].
Finally, our findings show a significant difference between the intervention and control groups regarding utilisation of PNC and under five-children’s clinics. Women in the intervention arm returned earlier for PNC and under five children’s clinic compared to those in the control arm. These findings are consistent with previous studies which showed that women who give birth at health facilities are more likely to return to the health facility for their PNC, under-five children’s clinic and subsequent deliveries [14, 45–49]. Thus, the findings highlight the effect of the intervention on women’s motivation to continuously use maternal health services after delivery. Going to the health facility for intra-partum care allows the woman and her new-born baby to receive care from a skilled birth attendant [50]. They compare the advantages of giving birth at the health facility with the dangers of delivering at home without skilled care. Moreover, during these visits, women receive health promotion messages about their health and that of the baby. These benefits motivate them to return to the health facilities in future. These findings highlight the importance of mitigating financial and other barriers in ensuring continuum of care for women and their newborn babies. They also suggest that mitigating barriers to institutional deliveries could motivate women to continue utilisation of other maternal and newborn health services even in the absence of an incentive such as the mother-baby pack.
Limitations
Possible limitations for the study should be acknowledged. First, use of one rural district in the southern part of the country may limit external validity of the findings to other regions with different geographical and demographic characteristics. Second, non-random allocation of facilities could have introduced selection bias. Further, the intervention was conducted over a one-year period; the long-term effects of the intervention on facility deliveries are not clear; follow-up studies are required to evaluate the impact of the intervention on women’s motivation to continuously use health facility delivery services after the intervention. In addition, we could not run analysis of covariance (ANCOVA) to account for the differences in gravidity. This could have led to confounding in our findings. However, most baseline variables were comparable between the intervention and control health facilities. In addition, the study did not measure the impact of the intervention on maternal mortality as it was out of its scope; evaluation studies are required to confirm this relationship. The study did not collect data on the healthcare related costs of the intervention. A follow-up study is required to determine the full cost of implementing such an intervention nationally.
Despite these limitations, we believe this study has brought out importance evidence on the effect of provision of a non-monetary incentive on increasing institutional deliveries, PNC and under-five children’s clinic. In addition, community intervention trials are the only appropriate study design suited for the evaluation of lifestyle interventions that cannot be allocated to individuals [51–54]. As opposed to clinical trials, community intervention trials focus on public health interventions that are focused on reducing the risk or burden of disease and/or mortality within a community context. Our use of this design employing a large sample size increased the external validity of the findings. The effective buffer area between the intervention and control regions prevented women from crossing over to either side, minimised the spillover effect and potential misclassification bias. To our knowledge, this is the first study to be undertaken to evaluate effects of provision of non-financial incentives in increasing institutional deliveries in rural Zambia.
Conclusion
These findings provide evidence for the effectiveness of the additional health education sessions and a mother-baby delivery pack on increasing institutional deliveries, PNC and under-five children’s clinic utilisation in rural Zambia. They could serve as a basis for policies and interventions focusing on designing effective interventions to address reversible barriers to health facility delivery, PNC and under-five children’s clinic under skilled care, especially in developing countries where poverty, home deliveries and high maternal mortality are high. Future studies should focus on 1) measuring the impact of the intervention on maternal mortality reduction and improving maternal health outcomes, and 2) determining the cost-effectiveness of such an intervention.
Supporting information
S1 Checklist
CONSORT 2010 checklist of information to include when reporting a randomised trial.(PDF)
Funding Statement
This work was supported by the World Health Organization, UNICEF and Zambian Ministry of Health (award/grant number: N/A) as part of the contribution to VM's doctoral research. UNICEF bought 1,700 mother-baby delivery packs and WHO contributed fuel for both delivery of the packs and trips for supervision. The Zambian Ministry of Health bought all mosquito nets for the packs and provided transport for distribution of packs to the health facilities in the intervention region. Please state what role the funders took in the study. If the funders had no role, please state: The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.
Data Availability
Data are available upon reasonable request from the TDRC ethics review board. This is based on the TDRC ethical policy. Address for the ethics committee: Tropical disease Research Centre (TDRC) Ethics Committee; Tel: +260212615444; email: mz.gro.crdt@scihte-crdt. This restriction is according to the TDRC policy and indeed all other IRBs in Zambia. In addition, I wish to confirm that Dr Nawa Mukumbuta (moc.liamg@awantkm) and Ms Priscilla Funduluka (moc.liamg@40akuludnufp), faculty members at Levy Mwanawasa Medical University, who did not collaborate in the study and not listed as authors on the manuscript, will separately and independently hold the de-identified data and respond to external requests for data access after clearance from the TDRC ethics review board according to the guidelines.
References
Decision Letter 0
11 Apr 2023
PONE-D-23-04893Effect of a non-financial incentive on institutional deliveries: A community intervention trial to address maternal mortality in rural ZambiaPLOS ONE
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Reviewer #1: A matched case-control clinical trial was conducted which aimed to investigate the association of myocilin gene mutations in Primary Open Angle Glaucoma (POAG). MYOC mutations were significantly associated with POAG. In fact, patients with MYOC mutations were 1.8 times more likely to develop POAG compared to those without the mutation.
Minor revisions:
1- Abstract: Name the statistical method used for the bivariate analysis.
2- Statistical Methods section:
a. Identify the descriptive statistical method used.
b. List the confounders used in the multivariate regression analysis.
c. Cite the statistical software used for the analysis.
d. State the criteria for determining a statistically significant p-value. For example include a statement similar to the following. “P-values less than 0.05 were considered statistically significant.”
3- Table 1: Since the study was not randomized, provide p-values to compare socio-demographic factors between the two groups.
4- Page 11: Name the statistical method used for the bivariate analysis.
5- Table 5: The title of table 5 is misleading since both univariate and multivariate logistic regression results are presented.
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Author response to Decision Letter 0
8 May 2023
Editorial comments
1. Please ensure that your manuscript meets PLOS ONE's style requirements, including those for file naming. The PLOS ONE style templates can be found at:
https://journals.plos.org/plosone/s/file?id=wjVg/PLOSOne_formatting_sample_main_body.pdf
Response: We have formatted the manuscripts according to the PLOS ONE style
2. Please provide additional details regarding participant consent. In the ethics statement in the Methods and online submission information, please ensure that you have specified what type you obtained (for instance, written or verbal, and if verbal, how it was documented and witnessed). If your study included minors, state whether you obtained consent from parents or guardians. If the need for consent was waived by the ethics committee, please include this information.
Response: We have edited this section accordingly (see page 8)
3. Please include the following request in the decision letter and ping me with follow up. “Please include a complete copy of PLOS’ questionnaire on inclusivity in global research in your revised manuscript. Our policy for research in this area aims to improve transparency in the reporting of research performed outside of researchers’ own country or community. The policy applies to researchers who have travelled to a different country to conduct research, research with Indigenous populations or their lands, and research on cultural artefacts. The questionnaire can also be requested at the journal’s discretion for any other submissions, even if these conditions are not met. Please find more information on the policy and a link to download a blank copy of the questionnaire here: https://journals.plos.org/plosone/s/best-practices-in-research-reporting. Please upload a completed version of your questionnaire as Supporting Information when you resubmit your manuscript.
Response: We have downloaded the questionnaire, filled it in and uploaded it.
4. Please ensure you have included the registration number for the clinical trial referenced in the manuscript.
Response: The registration numbers for referenced clinical trials have been included (see reference# 14 and 16)
5. Thank you for stating the following financial disclosure: "This work was supported by the World Health Organization, UNICEF and Zambian Ministry of Health (award/grant number: N/A) as part of the contribution to VM's doctoral research. UNICEF bought 1,700 mother-baby delivery packs and WHO contributed fuel for both delivery of the packs and trips for supervision. The Zambian Ministry of Health bought all mosquito nets for the packs and provided transport for distribution of packs to the health facilities in the intervention region.
Please state what role the funders took in the study. If the funders had no role, please state: "The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript." If this statement is not correct you must amend it as needed. Please include this amended Role of Funder statement in your cover letter; we will change the online submission form on your behalf.
Response: We appreciate this guide. We have now edited this section to state that the: “The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript." (see page 13)
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Response: We appreciate the guidance. We have now edited this part in the manuscript to read: “The authors have declared that no competing interests exist.” (see page 13)
7. We note that you have indicated that data from this study are available upon request. PLOS only allows data to be available upon request if there are legal or ethical restrictions on sharing data publicly. For information on unacceptable data access restrictions, please see http://journals.plos.org/plosone/s/data-availability#loc-unacceptable-data-access-restrictions
7a) If there are ethical or legal restrictions on sharing a de-identified data set, please explain them in detail (e.g., data contain potentially identifying or sensitive patient information) and who has imposed them (e.g., an ethics committee). Please also provide contact information for a data access committee, ethics committee, or other institutional body to which data requests may be sent
Response: We appreciate this comment. There are no legal restrictions on deidentified data as such. However, it is a TDRC ethics committee policy, just like many other IRBs in Zambia and elsewhere, that express permission should be sought from and granted by the ethics committee before data are publicly shared. The principal investigator can request for this permission if the journal needs the data. The corresponding author can then share it. We have now edited this section to read: Data are available upon reasonable request from the corresponding author and with permission of the TDRC ethics review board. This is based on the TDRC ethical policy (see page 13)
Address for the ethics committee: Tropical disease Research Centre (TDRC) Ethics Committee; Tel: +260212615444; email:mz.gro.crdt@scihte-crdt
b) If there are no restrictions, please upload the minimal anonymized data set necessary to replicate your study findings as either Supporting Information files or to a stable, public repository and provide us with the relevant URLs, DOIs, or accession numbers. Please see http://www.bmj.com/content/340/bmj.c181.long for guidelines on how to de-identify and prepare clinical data for publication. For a list of acceptable repositories, please see http://journals.plos.org/plosone/s/data-availability#loc-recommended-repositories
Response: This explained in section “a” above
8. Please amend either the title on the online submission form (via Edit Submission) or the title in the manuscript so that they are identical
Response: The title has been amended accordingly
9. Please amend the manuscript submission data (via Edit Submission) to include authors Dr. Kangwa I. M. Muma, Dr. Robin Bailey, Dr. Jessie I. M. Nyalazi, Dr. George Zulu, Dr. Tyness S. Mumba-Malisawa, Dr. Lillian M. L. Chinama-Musonda, Dr. Kachikonyo Sibande-Muma, Dr. Consity Mwale, Dr. Alex Makupe, Dr. Gardner Syakantu, Dr. Patrick Kaonga, Dr. Edgar Simulundu and Dr. Charles Michelo
Response: These authors are not part of this study; they are appearing on the other manuscript we submitted to this journal. The two submissions are different. These authors are on the study: Association between synonymous myocilin mutations and primary open angle glaucoma: A case-control study of patients attending selected referral eye care health facilities in Zambia
10. Please amend your authorship list in your manuscript file to include author Dr. Victor Mukonka, Dr. Fionnuala M McAuliffe, Dr. Olusegun Babaniyi, Dr. Sarai Malumo, Dr. Joseph Phiri and Dr. Patricia Fitzpatrick
Response: These authors are already appearing on the manuscript (see page 1)
11. Please amend either the abstract on the online submission form (via Edit Submission) or the abstract in the manuscript so that they are identical.
Response: This has been done accordingly and the two are now identical (see page 2)
12. Please include your full ethics statement in the ‘Methods’ section of your manuscript file. In your statement, please include the full name of the IRB or ethics committee who approved or waived your study, as well as whether or not you obtained informed written or verbal consent. If consent was waived for your study, please include this information in your statement as well.
Response: The ethics statement in the methods section has been edited to include a full statement (see page 8)
13. Please include captions for your Supporting Information files at the end of your manuscript, and update any in-text citations to match accordingly. Please see our Supporting Information guidelines for more information: http://journals.plos.org/plosone/s/supporting-information
Response: This has been done (see page 14)
14. Please review your reference list to ensure that it is complete and correct. If you have cited papers that have been retracted, please include the rationale for doing so in the manuscript text, or remove these references and replace them with relevant current references. Any changes to the reference list should be mentioned in the rebuttal letter that accompanies your revised manuscript. If you need to cite a retracted article, indicate the article’s retracted status in the References list and also include a citation and full reference for the retraction notice.
Response: The reference list has been reviewed and updated accordingly. No retracted articles have been cited.
Reviewer's Responses to Questions
1. Abstract: Abstract: Name the statistical method used for the bivariate analysis
Response: We have edited the abstract and indicated that we used the independent T-test and Chi-Square test to measure the differences in means and proportions between the two groups (see page 2)
2. Statistical Methods section:
a. Identify the descriptive statistical method used.
b. List the confounders used in the multivariate regression analysis.
c. Cite the statistical software used for the analysis.
d. State the criteria for determining a statistically significant p-value. For example include a statement similar to the following. “P-values less than 0.05 were considered statistically significant.”
Response: We appreciate the comment; We have included this information in the abstract and mentioned that analysis were conducted using using R-studio statistical software version 4.2.1 (see page 2).
3. Table 1: Since the study was not randomized, provide p-values to compare socio-demographic factors between the two groups
Response: We appreciate the guidance; the p-values have been provided in table 1.
4. Name the statistical method used for the bivariate analysis
Response: We have edited the abstract and indicated that we used the independent T-test and Chi-Square test to measure the differences in means and proportions between intervention and control groups (see page 7)
5. Table 5: The title of table 5 is misleading since both univariate and multivariate logistic regression results are presented
Response: We are not sure about this comment; we only submitted four tables and we did not carry out regression analysis. We conducted ANOVA which we presented in table 4. It appears there was a mixup on the two studies we submitted.
6. To assist in the review process, add line numbering to the document.
Response: We have added line numbering accordingly.
Decision Letter 1
10 Aug 2023
PONE-D-23-04893R1Effect of a non-financial incentive on institutional deliveries: A community intervention trial to address maternal mortality in rural ZambiaPLOS ONE
Dear Dr. Sialubanje,
Thank you for submitting your manuscript to PLOS ONE. After careful consideration, we feel that it has merit but does not fully meet PLOS ONE’s publication criteria as it currently stands. Therefore, we invite you to submit a revised version of the manuscript that addresses the points raised during the review process.
The manuscript has been evaluated by three reviewers, and their comments are available below. The reviewers have raised a number of major concerns. In particular, they request major revisions to improve the quality of the reporting throughout the manuscript. There are also concerns about the quality of the analyses, and the conclusions should be revised to ensure that they are presented appropriately.
Could you please carefully revise the manuscript to address all comments raised?
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Reviewers' comments:
Reviewer's Responses to Questions
Comments to the Author
1. If the authors have adequately addressed your comments raised in a previous round of review and you feel that this manuscript is now acceptable for publication, you may indicate that here to bypass the “Comments to the Author” section, enter your conflict of interest statement in the “Confidential to Editor” section, and submit your "Accept" recommendation.
Reviewer #1: (No Response)
Reviewer #2: (No Response)
Reviewer #3: (No Response)
**********
2. Is the manuscript technically sound, and do the data support the conclusions?
The manuscript must describe a technically sound piece of scientific research with data that supports the conclusions. Experiments must have been conducted rigorously, with appropriate controls, replication, and sample sizes. The conclusions must be drawn appropriately based on the data presented.
Reviewer #1: Yes
Reviewer #2: No
Reviewer #3: Partly
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3. Has the statistical analysis been performed appropriately and rigorously?
Reviewer #1: Yes
Reviewer #2: No
Reviewer #3: Yes
**********
4. Have the authors made all data underlying the findings in their manuscript fully available?
The PLOS Data policy requires authors to make all data underlying the findings described in their manuscript fully available without restriction, with rare exception (please refer to the Data Availability Statement in the manuscript PDF file). The data should be provided as part of the manuscript or its supporting information, or deposited to a public repository. For example, in addition to summary statistics, the data points behind means, medians and variance measures should be available. If there are restrictions on publicly sharing data—e.g. participant privacy or use of data from a third party—those must be specified.
Reviewer #1: No
Reviewer #2: Yes
Reviewer #3: No
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5. Is the manuscript presented in an intelligible fashion and written in standard English?
PLOS ONE does not copyedit accepted manuscripts, so the language in submitted articles must be clear, correct, and unambiguous. Any typographical or grammatical errors should be corrected at revision, so please note any specific errors here.
Reviewer #1: Yes
Reviewer #2: Yes
Reviewer #3: No
**********
6. Review Comments to the Author
Please use the space provided to explain your answers to the questions above. You may also include additional comments for the author, including concerns about dual publication, research ethics, or publication ethics. (Please upload your review as an attachment if it exceeds 20,000 characters)
Reviewer #1: Minor revision:
1- Line 61: R-studio is a development environment for R. It is important to state the version of R that was used for conducting the analysis. In fact, the use of R-studio is rarely noted in manuscripts.
2- Line 59: Chi-square and independent t-tests are used to make comparisons between arms. Be sure to include the word "compare" or "comparisons" in this sentence.
3- Line 61: Clarify if "(p-value < 0.05)" implies that p-values < 0.05 were considered statistically significant.
4- Line 198: The independent t-test and chi-square tests are actually inferential tests rather than descriptive statistics. Descriptive statistics are means, standard deviations, frequencies, and percentages, etc.
5- Supplementary Table 1 contains replicates of the variables.
6- Supplementary Tables 2 and 3: State a more precise p-values rather than > 0.05.
Note: Line numbers refers to those in the tracked changes of revision 1.
Reviewer #2: General:
- The introduction is too brief and lacks key information for the reader. There is no information on ANC or on related interventions and their effectiveness. What have we already learned that led the authors to design and test this specific intervention? There should be sufficient information that a reader can glean this from the introduction.
- This manuscript reports findings from a randomized trial. The CONSORT guidelines should be used to ensure all relevant information is included. I suggest the authors download the CONSORT checklist and verify all information is included.
- The statistical analysis is not appropriate for the trial design. This was a cluster randomized trial; therefore, facility-level clustering needs to be accounted for in the analysis or standard errors will not be approrpriately estimated, potentially biasing the results and leading to incorrect interpretation. I have provided more details below. Moreover, characteristics that were different between arms at baseline should be adjusted for.
- There should be some analysis of participants lost to follow up. Are these women significantly different? How might this bias results?
- I cannot fully evaluate the results or discussion at this time given the limitations of the methods (lack of information).
- Were women not exposed to the intervention at different points of their pregnancy? The authors should expand on the timing of outcome measures relative to the intevention. If women were enrolled at their first ANC visit, it is unclear to me whether they were observed after the conclusion of the intervention as this is not clear from the methods section.
Abstract:
- Please define secondary outcomes reported as results here.
- The abstract attributes the difference in arms to the mother-baby pack, but the abstract notes that the intervention also included health education. Is the difference attributed to both or can the authors statistically isolate the effect of the mother-baby pack? Either way, this should be clear in the abstract.
Introduction:
- Line 82-83: “Home deliveries…” this sentence makes a claim that should be supported by a citation(s).
- Why is there no information or literature review on ANC in the introduction if this is a key component of the intervention evaluated? Please describe relevant background on ANC, including number of recommended visits and attendance rates (e.g., from the most recent DHS) in Zambia, and barriers to ANC (could be more broadly, as relevant to the study populatoin).
Methods:
- Are there any private facilities that can support deliveries?
- The secondary outcome measures need to be more clearly defined. For example, “knowledge of pregnancy danger signs” is vague.
- How was the randomization conducted?
- Inofrmation about recruitment should be in the enrollment section (around line 167).
- The abstract states analysis was done in R but the methods section states analysis was conducted in SPSS. Please clarify so that this is consistent.
- The inforamtion about data collection is insufficient. Please state where 2012 and 2013 data come from, and exactly what data was collected (e.g., precisely what measures were on the data extraction sheet, who extracted data). What is the timing of paper-based questionnaires (“PNC” is far too vague, for example). How were interviewers trained? Where were interviews conducted?
- All non-descriptive analyses require clustering of the standard errors by facility given the study design. The authors should use regression models (e.g., linear, logistic depending on the outcome) with standard errors clustered by health facility. Otherwise, the independence assumption is violated which will bias standard errors and thus potentially lead to incorrect inferences about the statistical significance of the estimated relationships.
- Regression models estimating the effect of the intervention should also adjust for factors that were significantly differnet between arms at baseline, such as gravidity. Otherwise, this may be a spurious relationship.
Results:
- Please include some analysis of participants lost to follow up. Are these women different from retained participants, and if so, how?
Limitations:
- The authors should describe biases related to non-random allocation of facilities and whether there are potential selection biases related to including only public-sector facilities.
Minor comments:
- Line 84: Demographic & Health Survey should be capitalized
- Line 108: chane aim to objective, remove “study also” for clarity
- Lines 252 and 254: please include units
Reviewer #3: This is a very important and informative study. However, I have a few concerns that need to be addressed. The statement "Participants in the intervention arm received ANC,health education and a mother-baby delivery pack when they arrived at the health facility for delivery" in your abstract is misleading. Please re-write.
Please re-write objectives stated in line 108-109 to align with the abstract and the rest of the document. The document still has alot of typos; e.g line 326-importance versus important; 327 "community intervention trials are the only appropriate study design suited...". Please revisit and re-write for clarity.
You mention that study participants were identified from the first ANC visits, was this part of your screening criteria?
You later state these differences in healthservice utilization, alongside other variables like gravidity, first ANC utilization, how did you take care of these and other obvious confounders? Please describe your multivariate analysis in more detail.
Please report ALL secondary outcomes in the outcome tables and results section before embarking on their discussion.
Line 257 states, "health facility deliveries in the intervention and control sites from January 2012 to Dec 2014....", and then proceed with the same narrative in line 182 and else where. Was baseline data collection part of this study? Please clarify confusion this because you statee in line 319 that "the study was conducted over a one year period". Please also clarify how you treated baseline and comparative data in this/these studies.
Your conclusion seems to "mute" other outcomes described and discussed in the study/effect of other intervention components aside from provision of a other-baby delivery pack. Please explain this.
Remove references from the conclusion section.
Line 343, "study findings also show that the intervention in implementable". What do you mean?? The authors did not investigate implementation and do not document any implementation outcomes in this particular study. They even mention quite a number of limitations including a lack of costing, cost-effectiveness data among others, making it premature to make such assertions/conclusions.
I would also consider the last six sentences of the conclusion to fall back into the discussion section, and authors to direct the readers on solid conclusions derived from the study data presented in this manuscript, plus make appropriate recommendations for further research/investigation.
**********
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Reviewer #1: No
Reviewer #2: No
Reviewer #3: No
**********
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Author response to Decision Letter 1
11 Sep 2023
Responses to Reviewers’ comments
Reviewer # 1: Minor revision:
Query 1: Line 61: R-studio is a development environment for R. It is important to state the version of R that was used for conducting the analysis. In fact, the use of R-studio is rarely noted in manuscripts.
Response: We appreciate the comment from the reviewer. We mentioned in the abstract and methods sections that the Analysis was conducted using R-studio statistical software version 4.2.1 (see pages and 7).
Query 2: Line 59: Chi-square and independent t-tests are used to make comparisons between arms. Be sure to include the word "compare" or "comparisons" in this sentence.
Response: We appreciate the observation; we have made the change accordingly (page 2)
Query 3: Line 61: Clarify if "(p-value < 0.05)" implies that p-values < 0.05 were considered statistically significant.
Response: We appreciate the comment. We have now clarified that the p-value<0.05 was considered significant (see page 2 and 7).
Query 4: Line 198: The independent t-test and chi-square tests are actually inferential tests rather than descriptive statistics. Descriptive statistics are means, standard deviations, frequencies, and percentages, etc.
Response: We thank the reviewer for the comment. We have now corrected the sentence to read: “Descriptive statistics (frequencies, percentages, proportions, means and standard deviations) was used to summarise participant socio-demographic and clinical data as well as institutional deliveries in intervention and control areas for each year” (see page 7)
Query 5: Supplementary Table 1 contains replicates of the variables.
Response: We have corrected the table and removed all the replicate variables (see table 1).
Query 6: Supplementary Tables 2 and 3: State a more precise p-values rather than > 0.05.
Response: The tables have been corrected accordingly (see tables 2 and 3)
Reviewer #2: General:
Query 1: The introduction is too brief and lacks key information for the reader. There is no information on ANC or on related interventions and their effectiveness. What have we already learned that led the authors to design and test this specific intervention? There should be sufficient information that a reader can glean this from the introduction.
Response: We thank the reviewer for the insightful feedback. We have edited the introduction and added a section on antenatal care [ see pages 4 and 5)
Query 2: This manuscript reports findings from a randomized trial. The CONSORT guidelines should be used to ensure all relevant information is included. I suggest the authors download the CONSORT checklist and verify all information is included.
Response: We appreciate the reviewer’s comment. The CONSORT guidelines was used and filled in accordingly
Query 3: The statistical analysis is not appropriate for the trial design. This was a cluster randomized trial; therefore, facility-level clustering needs to be accounted for in the analysis or standard errors will not be approrpriately estimated, potentially biasing the results and leading to incorrect interpretation. I have provided more details below. Moreover, characteristics that were different between arms at baseline should be adjusted for.
Response: We thank the reviewer for the comments. The respondent characteristics at baseline were compared between the intervention and control sites (see table 1). There was no significant difference between the two groups with regard to age, number of children and antenatal care booking. A significant difference between the two groups with regard to gravidity. Stratified analysis of variance ANOVA comparing the mean number of deliveries before and after the intervention in the same facilities accounts for any potential facility-level clustering. Moreover, we have explained that both intervention and control regions had similar health facilities regarding the location (rural), size and catchment population, socio-economic and demographic profiles. The two regions mainly served peasant and subsistence farmers of the same tribe who shared same cultural, traditional practices and beliefs. To ensure that the two regions were comparable with regard to population size, population data for the two regions was obtained from the Central Statistical Office in Zambia (see page 6).
Query 4: There should be some analysis of participants lost to follow up. Are these women significantly different? How might this bias results? I cannot fully evaluate the results or discussion at this time given the limitations of the methods (lack of information).
Response: We appreciate the comment from the reviewer. We mentioned that a total of 5,000 pregnant women were initially recruited into the study; meaning that they expressed interest and willingness to participate in the study. This was done at first contact in the antenatal care clinic. However, for various reasons, not clearly understood, 500 (10%) never returned to the health facility for follow up. Thus, they were deemed not part of the study since they were not exposed to the study and information on these is not available (see page 10).
Query 5: Were women not exposed to the intervention at different points of their pregnancy? The authors should expand on the timing of outcome measures relative to the intervention. If women were enrolled at their first ANC visit, it is unclear to me whether they were observed after the conclusion of the intervention as this is not clear from the methods section.
Response: We thank the reviewer for the insightful comment. Yes, women were identified from the ANC clinics, when they went for their first ANC visit, regardless of the stage of their pregnancy (gestation). The outcome of interest was coming to the health facility for delivery (institutional delivery). Thus, their follow up ended when they delivered; either at the health facility or home. They were not observed after the intervention. To ensure that no woman gave birth after the end of the follow up period, care was taken during recruitment to ensure that only women whose expected date of delivery (EDD) fell before 30th Nover, 2014 were recruited into the study. We picked on 30th November to allow for one month window for women who would experience prolonged gestation beyond 40 weeks to be observed. Participant recruitment ended in mid- year (June, 2014) so that the last delivery would be expected before the end of the intervention in December, 2013. In this case, no further follow up was not needed after the study. Moreover, this avoided the need for right censoring in our analysis (see page 8).
Abstract:
Query 6: Please define secondary outcomes reported as results here.
Response: We have made the correction accordingly (see page 2)
Query 7: The abstract attributes the difference in arms to the mother-baby pack, but the abstract notes that the intervention also included health education. Is the difference attributed to both or can the authors statistically isolate the effect of the mother-baby pack? Either way, this should be clear in the abstract
Response: We have corrected the conclusion section in the abstract to include. It now reads as follows: “These findings provide evidence for the effectiveness of the mother-baby delivery pack and additional health education sessions on increasing institutional deliveries in rural Zambia” (see page 2).
Introduction:
Query 8 : Line 82-83: “Home deliveries…” this sentence makes a claim that should be supported by a citation(s).
Response: We have included the citations accordingly (see page 4)
Query 9: Why is there no information or literature review on ANC in the introduction if this is a key component of the intervention evaluated? Please describe relevant background on ANC, including number of recommended visits and attendance rates (e.g., from the most recent DHS) in Zambia, and barriers to ANC (could be more broadly, as relevant to the study population).
Response: We thank the reviewer for the thoughtful comment. We have added information on ANC in Zambia (see page 4 and 5)
Methods:
Query 10: Are there any private facilities that can support deliveries?
Response: We have edited the section on the study setting and added more detail on the health facilities in the district. We have also mentioned that, at the time, there were no private health facilities providing obstetric and newborn care in the district (see page 6).
Query 11: The secondary outcome measures need to be more clearly defined. For example, “knowledge of pregnancy danger signs” is vague.
Response: We have edited the sentence to read: “The secondary outcome measures were: 1) antenatal care service utilisation; 2) postnatal care service utilisation by mother and baby; 3) under-five clinic service utilisation
Query 12 : How was the randomization conducted?
Response: We used cluster sampling; allocation was done at the cluster/ rural region level; the district was stratified into two rural regions separated in the middle by the town centre. The region on the western side was allocated to the intervention arm; the one on the eastern side as the control arm. Eight health facilities were included in each arm (see page 6 under trial design and randomisation)
Query 13: Information about recruitment should be in the enrolment section (around line 167).
Response: This has been noted and corrected accordingly (see page 7)
Query 14: The abstract states analysis was done in R but the methods section states analysis was conducted in SPSS. Please clarify so that this is consistent.
Response: This was an error. We have now corrected it to read, “analysis was conducted using R-studio statistical software version 4.2.1” (see page 9).
Query 15: The information about data collection is insufficient. Please state where 2012 and 2013 data came from, and exactly what data was collected (e.g., precisely what measures were on the data extraction sheet, who extracted data).
Response: We thank the reviewer for the insightful question and comment. We have now explained that both the baseline and intervention data were collected by a pair of data collectors under the supervision of the principal investigator. In order to establish baseline delivery data prior to commencement of the intervention, year-long delivery records for 2012 and 2013 were reviewed and delivery data collected from the delivery registers at each health facility in the study sites, using a data extraction sheet. The data extraction sheet comprised various sections including demographics (age, place of residence), gravidity, parity, gestation, pre-existing medical conditions (hypertension, HIV, anaemia), expected date of delivery, date of delivery, place of delivery, mode of delivery, delivery outcome, baby condition and outcome (see page 9).
Query 16: What is the timing of paper-based questionnaires (“PNC” is far too vague, for example).
Response: We have explained that the paper-based questionnaire data was collected at 3 time points: at enrolment into the study during the ANC clinic, in the labour ward when the woman came for delivery and when the woman and baby came for the first PNC visit (see page 9)
Query 17: How were interviewers trained? Where were interviews conducted?
Response: We thank the reviewer for the comment. We have provided a detailed explanation on how the data collectors were trained: the training lasted 4 days (3 days three and 1 day practical). No interviews were conducted; rather a structured questionnaire was administered by midwives who were trained as data collectors. Above we have explained when and where the data was collected from (in the ANC, delivery and PNC clinics (see page 9)
Query 18: All non-descriptive analyses require clustering of the standard errors by facility given the study design. The authors should use regression models (e.g., linear, logistic depending on the outcome) with standard errors clustered by health facility. Otherwise, the independence assumption is violated which will bias standard errors and thus potentially lead to incorrect inferences about the statistical significance of the estimated relationships. Regression models estimating the effect of the intervention should also adjust for factors that were significantly differnet between arms at baseline, such as gravidity. Otherwise, this may be a spurious relationship.
Response: We thank the reviewer for the observation and comment. The aim of the tudy was to determine the effect of provision of additional health education during antenatal care (ANC) and a non-financial incentive on institutional deliveries. In our view, this effect can be tested using different models: analysis of various (ANOVA) or regression (linear, logistic or Poisson). In this case, we opted for one way ANOVA. We compared the mean number of deliveries between the intervention and control arms in the 3 years (2012, 2013 and 2014). Since there was no significant difference with regard to the variables of interest at baseline between the intervention and control arms, we attributed any observed difference in the number of deliveries to the intervention. Moreover, we believe that comparing the mean number of deliveries before and after the intervention in the same facilities accounted for any potential facility-level clustering (see response to query 3 above). In addition, we did not use linear regression because the aim of the study was not to identify the predictors of utilisation of delivery services. We believe the information we got and presented (F(1,46)=18.85, p<0.001) from ANOVA is as useful as the one we would have obtained from linear regression which looks at the goodness of fit for the model and the explained variance (R2). Due to other technical issues, we could not run analysis of covariance (ANCOVA) to account for the differences in gravidity. However, we have taken note of this and explained this weakness in our limitation section (see page 14)
Results
Query 19: Please include some analysis of participants lost to follow up. Are these women different from retained participants, and if so, how?
Response: We appreciate the comment; we have responded to this point already (see response to query 4 above).
Limitations:
Query 20: The authors should describe biases related to non-random allocation of facilities and whether there are potential selection biases related to including only public-sector facilities.
Response: We appreciate this guidance. We have described the biases related to non-random allocation of facilities (see page 14). We have explained that at the time of the study there were no private facilities providing obstetric and newborn healthcare services in the district (see page 10).
Minor comments:
Query 21: Line 84: Demographic & Health Survey should be capitalized
Response: This has been corrected accordingly (see page 4)
Query 22: Line 108: change aim to objective, remove “study also” for clarity
Response: This has been corrected accordingly (see page 5)
Query 23: Lines 252 and 254: please include units
Response: This has been corrected accordingly (see page 11, 12)
Reviewer #3:
This is a very important and informative study. However, I have a few concerns that need to be addressed.
Query 1: The statement "Participants in the intervention arm received ANC, health education and a mother-baby delivery pack when they arrived at the health facility for delivery" in your abstract is misleading. Please re-write.
Response: This has been corrected. The sentence now reads: In addition to the health education provided during routine ANC visits, participants in the intervention arm received health education and a mother-baby delivery pack when they arrived at the health facility for delivery (see page 2).
Query 2: Please re-write objectives stated in line 108-109 to align with the abstract and the rest of the document.
Response: The objective has been corrected (see page 2)
Query 3: The document still has a lot of typos; e.g line 326-importance versus important; 327 "community intervention trials are the only appropriate study design suited...". Please revisit and re-write for clarity.
Response: We have proof-read the whole document and corrected all the typo errors.
Query 4: You mention that study participants were identified from the first ANC visits, was this part of your screening criteria?
Response: Yes, the participants were identified during their first ANC visit so that they could be screened for their eligibility. Pregnant people who came for ANC at any gestation, regardless of the number of visits, was eligible to participate. However, since the outcome of interest was place of delivery (institutional or home delivery), care was taken to ensure that only women whose expected date of delivery (EDD) fell before 30th Nover, 2014 were recruited into the study (see page 7).
Query 5: You later state these differences in health service utilization, alongside other variables like gravidity, first ANC utilization, how did you take care of these and other obvious confounders? Please describe your multivariate analysis in more detail.
Response: We thank the reviewer for the insightful comments. We have explained above (under reviewer # 2 query 18) that the objective of the study was to assess the effect of provision of additional health education during antenatal care (ANC) and a non-financial incentive on institutional deliveries. In our view, this effect can be tested using different models: analysis of various (ANOVA) or regression (linear, logistic or Poisson). In this case, we opted for one way ANOVA. We compared the mean number of deliveries between the intervention and control arms in the 3 years (2012, 2013 and 2014).
Since there was no significant difference with regard to the variables of interest at baseline between the intervention and control arms, we attributed any observed difference in the number of deliveries to the intervention. Moreover, we believe that comparing the mean number of deliveries before and after the intervention in the same facilities accounted for any potential facility-level clustering (see response to query 3 above). In addition, we did not use multivariate linear regression models because the objective of the study was not to identify the predictors of utilisation of delivery services. We believe the information we got and presented (F(1,46)=18.85, p<0.001) from ANOVA is as useful as the one we would have obtained from linear regression which looks at the goodness of fit for the model and the explained variance (R2).
Query 6: Please report ALL secondary outcomes in the outcome tables and results section before embarking on their discussion.
Response: We appreciate the guidance by the reviewer. We have now reported all the secondary outcomes in the results section (see page 13)
Query 7: Line 257 states, "health facility deliveries in the intervention and control sites from January 2012 to Dec 2014....", and then proceed with the same narrative in line 182 and else where. Was baseline data collection part of this study? Please clarify confusion this because you state in line 319 that "the study was conducted over a one year period". Please also clarify how you treated baseline and comparative data in this/these studies.
Response: We thank the reviewer for the comment. We have now explained that this was a three-year study (2012 to 2014) analysing baseline delivery data for 2012 and 2013 followed by one-year (1st January to 31st December 2014) prospective community intervention trial conducted in Monze district, Zambia (see page 6).
Query 8: Your conclusion seems to "mute" other outcomes described and discussed in the study/effect of other intervention components aside from provision of a other-baby delivery pack. Please explain this.
Remove references from the conclusion section.
Response: The conclusion has been edited both in the abstract and main document and highlights all the outcomes described and discussed in the document.
Query 9: Line 343, "study findings also show that the intervention in implementable". What do you mean?? The authors did not investigate implementation and do not document any implementation outcomes in this particular study. They even mention quite a number of limitations including a lack of costing, cost-effectiveness data among others, making it premature to make such assertions/conclusions. I would also consider the last six sentences of the conclusion to fall back into the discussion section, and authors to direct the readers on solid conclusions derived from the study data presented in this manuscript, plus make appropriate recommendations for further research/investigation.
Response: This section has been edited and the sentence, “study findings also show that the intervention is implementable” has been deleted. We have also made recommendations for future research/investigation (see page 16)
Decision Letter 2
7 Nov 2023
PONE-D-23-04893R2Effect of a non-financial incentive on institutional deliveries: A community intervention trial to address maternal mortality in rural ZambiaPLOS ONE
Dear Dr. Sialubanje,
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Reviewers' comments:
Reviewer's Responses to Questions
Comments to the Author
1. If the authors have adequately addressed your comments raised in a previous round of review and you feel that this manuscript is now acceptable for publication, you may indicate that here to bypass the “Comments to the Author” section, enter your conflict of interest statement in the “Confidential to Editor” section, and submit your "Accept" recommendation.
Reviewer #1: All comments have been addressed
Reviewer #2: (No Response)
Reviewer #3: All comments have been addressed
**********
2. Is the manuscript technically sound, and do the data support the conclusions?
The manuscript must describe a technically sound piece of scientific research with data that supports the conclusions. Experiments must have been conducted rigorously, with appropriate controls, replication, and sample sizes. The conclusions must be drawn appropriately based on the data presented.
Reviewer #1: (No Response)
Reviewer #2: Yes
Reviewer #3: Yes
**********
3. Has the statistical analysis been performed appropriately and rigorously?
Reviewer #1: (No Response)
Reviewer #2: Yes
Reviewer #3: Yes
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4. Have the authors made all data underlying the findings in their manuscript fully available?
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Reviewer #1: (No Response)
Reviewer #2: Yes
Reviewer #3: Yes
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Reviewer #1: (No Response)
Reviewer #2: Yes
Reviewer #3: Yes
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6. Review Comments to the Author
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Reviewer #1: (No Response)
Reviewer #2: The authors have thoughtfully addressed many of the points I raised in my first review of this paper. I appreciate their careful consideration of these broad issue, which required a significant revision on their part. This version of the manuscript is greatly improved. Overall, this version was much easier to read, and I especially appreciated the expanded introduction and methods sections.
It might be underselling the importance of this trial to refer to the mother-baby pack as a non-financial incentive. This is a key cost-related barrier that the authors directly addressed and I would hate for this finding to get lost, which it somewhat does in the current abstract and first paragraph of the discussion, and the conclusion. The authors might add that the pack in both places that the pack includes essential delivery supplies, which would otherwise be an out-of-pocket expense. Adding a few sentences to make it clear that an aim of the trial is to test the effect of covering this potential expense in-kind that is a major barrier to utilizing facility delivery may increase the reach of these important findings.
In general this version is much clearer and follows CONSORT guidelines for reporting trial results. I commend the authors for this very significant revision. My comments below are targeted towards further improving the manuscript.
Abstract
- It might be helpful to note that the 5,000 women were identified as eligible or enrolled at baseline but were not exposed to the intervention; otherwise this raises questions about loss to follow up (this point was addressed in the manuscript and response to reviewers). I would also clarify here that the 12.4% who completed the study were not included in analysis because of incomplete data (otherwise it is unclear why they were not included.
- The secondary outcomes remain poorly defined. For example, does “ANC” mean obtained any ANC vs. initiated ANC in the first trimester vs. completed at least 4 ANC visits, or something else?
- If the authors are concerned about word limit in the abstract given these other suggestions, they could remove the statistical software as this is not typically necessary to report in the abstract (the main text is sufficient).
Introduction:
- If 33% of women are delivering at home, I would not say it is consistent to state “most women still give birth at home” (line 104). Please revise “most” (of course this is a not insubstantial proportion and I support the authors’ efforts to increase facility delivery). It does seem that at study baseline a majority of women in the district had home deliveries but this is not supported by the ZDHS data. If the authors have access to the 2013 ZDHS, they might estimate the proportion of home deliveries in rural areas of the study region, which would be available in the dataset and might be >50%.
Methods:
- Intervention: Could the authors clarify, is it that mother-baby packs were made available for free at all facilities in the intervention area, or that each woman was specifically given one (say, at her home) around the time of delivery? The mother-baby pack should be stated as part of the intervention in the first sentence of this paragraph.
- Randomization: how was the actual randomization done, was it a coin flip or something else? Or did someone decide that west would be intervention?
- Outcomes: same comment as in the abstract, the secondary outcomes remain poorly defined. Please specify how each outcome is operationalized, e.g., “mother received a postnatal care visit within 48 hours of delivery.” This is somewhat done in the results but should be here as well.
- If women are followed through their first PNC visit, does this mean that under 5 clinic utilization refers to PNC for the baby/newborn follow up? It might be helpful to be more explicit about this, as I assumed this was care for acute illnesses until I read the results section.
Results:
- I appreciate that the authors included all p-values. However, while we might state that a p-value of .07 is not significant, it does suggest that there is an underlying difference that may be meaningful in some way or may be significant if the sample size was a little larger (line 299). The authors
Discussion:
- Paragraph beginning on line 351: what were the non-financial incentives in the other studies referenced? It would be helpful to more directly compare what kinds of incentives they were.
- This study does have strengths as the authors note on the paragraph starting on line 409. However, I think it not reasonable to say that this was the only possible study design for this particular trial because in theory mother-baby packs and health education could be randomized at the individual level (I agree with the authors that theirs is an appropriate design). I would also remove the sentence starting on line 417; yes longer data collection periods may have challenges but that does not mean that the accuracy is always lower.
Minor comments:
- Line 158: “assent” instead of “ascent”
Reviewer #3: Description of secondary outcomes is still vague
How did you choose the eight health centres?
You state that the questionaires were administered by the midwives who were trained as data collectors. Are these the same midwives running the labour ward, AND, PNC clinics? How did you deal with potential bias during data collection?
At what point was PNC data collected?
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Reviewer #1: No
Reviewer #2: No
Reviewer #3: No
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Author response to Decision Letter 2
15 Nov 2023
Response to reviewer comments
Reviewer # 2
Query 1: The authors have thoughtfully addressed many of the points I raised in my first review of this paper. I appreciate their careful consideration of these broad issue, which required a significant revision on their part. This version of the manuscript is greatly improved. Overall, this version was much easier to read, and I especially appreciated the expanded introduction and methods sections.
It might be underselling the importance of this trial to refer to the mother-baby pack as a non-financial incentive. This is a key cost-related barrier that the authors directly addressed and I would hate for this finding to get lost, which it somewhat does in the current abstract and first paragraph of the discussion, and the conclusion. The authors might add that the pack in both places that the pack includes essential delivery supplies, which would otherwise be an out-of-pocket expense. Adding a few sentences to make it clear that an aim of the trial is to test the effect of covering this potential expense in-kind that is a major barrier to utilizing facility delivery may increase the reach of these important findings
Response: We appreciate the complements from the reviewer and the concern about our referring to the mother-baby pack as a non-financial incentive. We have now corrected this both in the abstract and discussion. We have also corrected the title and conclusion sections accordingly. The aim now reads as: To test the effect of provision of additional health education during antenatal care (ANC) and a mother-baby delivery pack on institutional deliveries in Monze, Zambia.
Abstract
Query 2: It might be helpful to note that the 5,000 women were identified as eligible or enrolled at baseline but were not exposed to the intervention; otherwise this raises questions about loss to follow up (this point was addressed in the manuscript and response to reviewers). I would also clarify here that the 12.4% who completed the study were not included in analysis because of incomplete data (otherwise it is unclear why they were not included.
Response: We thank the reviewer for this observation. We have made the correction accordingly (page 2 line 31 to 34)
Query 2: The secondary outcomes remain poorly defined. For example, does “ANC” mean obtained any ANC vs. initiated ANC in the first trimester vs. completed at least 4 ANC visits, or something else?
- If the authors are concerned about word limit in the abstract given these other suggestions, they could remove the statistical software as this is not typically necessary to report in the abstract (the main text is sufficient).
Response: We appreciate the comment by the reviewer. We have now explained that ANC, PNC and under-five service utilisation means the time of the first visit, number of visits completed according to the national guidelines (see page 8).
A detailed explanation about ANC and PNC services in the country is provided in the introduction section.
Introduction:
Query 3: If 33% of women are delivering at home, I would not say it is consistent to state “most women still give birth at home” (line 104). Please revise “most” (of course this is a not insubstantial proportion and I support the authors’ efforts to increase facility delivery). It does seem that at study baseline a majority of women in the district had home deliveries but this is not supported by the ZDHS data. If the authors have access to the 2013 ZDHS, they might estimate the proportion of home deliveries in rural areas of the study region, which would be available in the dataset and might be >50%.
Response: We appreciate the guidance from the reviewer. We have corrected the sentence accordingly (see page 5 lines 122 to 124). We have also provided the statistics for the study district in the methods section under study setting (see page 7 lines 180 to 181)
Methods:
Query 4: Intervention: Could the authors clarify, is it that mother-baby packs were made available for free at all facilities in the intervention area, or that each woman was specifically given one (say, at her home) around the time of delivery? The mother-baby pack should be stated as part of the intervention in the first sentence of this paragraph.
Response: We have clarified that the mother-baby delivery packs were kept at the health facility; pregnant women only received them at the time of delivery if they went to deliver at the health facility. Information about the packs and their content was provided during the health education sessions as women went for their ANC visits (see pages 8 and 9). We have corrected the first sentence accordingly.
Query 5: Randomization: how was the actual randomization done, was it a coin flip or something else? Or did someone decide that west would be intervention?
Response: We appreciate the comment from the reviewer. We have now explained in detail how randomisation was done (see page 6 and 7)
Query 6: Outcomes: same comment as in the abstract, the secondary outcomes remain poorly defined. Please specify how each outcome is operationalized, e.g., “mother received a postnatal care visit within 48 hours of delivery.” This is somewhat done in the results but should be here as well. If women are followed through their first PNC visit, does this mean that under 5 clinic utilization refers to PNC for the baby/newborn follow up? It might be helpful to be more explicit about this, as I assumed this was care for acute illnesses until I read the results section
Response: We have now explained how each secondary outcome was operationalised (see page 9). For PNC there were three measures: did the mother and her baby receive PNC? Time after delivery when PNC was received? Number of PNC visits. Similarly, for ANC, the measures were: did the pregnant woman use ANC? Gestation at ANC booking, and number of ANC visits completed.
Results:
Query 7: I appreciate that the authors included all p-values. However, while we might state that a p-value of .07 is not significant, it does suggest that there is an underlying difference that may be meaningful in some way or may be significant if the sample size was a little larger (line 299).
Response: We appreciate the observation by the reviewer. We have now corrected this sentence to read: “There was a notable difference in the number of children between the respondents from the intervention (mean=3.6, SD=2.3) and control arms (mean=3.4, SD=2.2); however, the difference did not reach statistical significance (p=0.07) (see page 31)
Discussion:
Query 8: Paragraph beginning on line 351: what were the non-financial incentives in the other studies referenced? It would be helpful to more directly compare what kinds of incentives they were.
Response: We appreciate the guidance from the reviewer. We have now described the incentives provided in the cited studies (see page 15 lines 397 to 407)
Query 9: This study does have strengths as the authors note on the paragraph starting on line 409. However, I think it is not reasonable to say that this was the only possible study design for this particular trial because in theory mother-baby packs and health education could be randomized at the individual level (I agree with the authors that theirs is an appropriate design). I would also remove the sentence starting on line 417; yes longer data collection periods may have challenges but that does not mean that the accuracy is always lower.
Response: We appreciate the concern from the reviewer. We have now deleted the sentence accordingly (see page 17 lines 466 and 467)
Minor comments:
Query 10: Line 158: “assent” instead of “ascent”
Response: We have corrected this and all other typo errors in the document
Reviewer #3:
Query 1: Description of secondary outcomes is still vague
Response: we appreciate the observation by the reviewer. We have now described the secondary outcomes in detail. We have explained how each secondary outcome was operationalised (see page 9). For PNC there were three measures: did the mother and her baby receive PNC? Time after delivery when PNC was received? Number of PNC visits. Similarly, for ANC, the measures were: did the pregnant woman use ANC? Gestation at ANC booking, and number of ANC visits completed.
Query 2: How did you choose the eight health centres?
Response: We appreciate the observation from the reviewer. We have now explained how the 8 health centres were selected (see page 6 and 7)
Query 3: You state that the questionaires were administered by the midwives who were trained as data collectors. Are these the same midwives running the labour ward, AND, PNC clinics? How did you deal with potential bias during data collection?
Response: We thank the reviewer for the observation. We have now explained that the midwives who collected the data were not involved in the service (ANC, delivery and PNC) provision. We have also mentioned that several measures were taken to ensure quality and avoid bias during the data collection process: data collectors were trained and worked under the supervision of the principla investigators and other research team members. In addition, midwives who participated in data collection were not involved in service provision (see page 10).
Query 4: At what point was PNC data collected?
Response: We thank the reviewer for the question. We mentioned under data collection section that PNC data was collected after delivery and when women came for PNC visits (see page 10)
Decision Letter 3
5 Dec 2023
Effect of a mother-baby delivery pack on institutional deliveries: A community intervention trial to address maternal mortality in rural Zambia
PONE-D-23-04893R3
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Acceptance letter
14 Dec 2023
PONE-D-23-04893R3
PLOS ONE
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