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Clinical Trial
. 1996 Nov;54(5):281-6.
doi: 10.1016/s0010-7824(96)00180-1.

The use of nomegestrol acetate subdermal contraceptive implant, uniplant, during lactation

Affiliations
Clinical Trial

The use of nomegestrol acetate subdermal contraceptive implant, uniplant, during lactation

H Abdel-Aleem et al. Contraception. 1996 Nov.

Abstract

Uniplant is a single contraceptive implant intended for one year use. It contains the progestogen nomegestrol acetate. The clinical performance and the effect of its use during the first postpartum year on breastfeeding performance and growth and health of the infants were studied and compared to the findings in a parallel group who used an intrauterine contraceptive device (IUD) in a prospective, non-randomized study. This was carried out in Assiut, Egypt. Two-hundred-forty fully breastfeeding mothers asking for initiation of contraception early postpartum were assigned according to their choices into either nomegestrol subdermal contraceptive implant (Uniplant) (120 women) or intrauterine contraceptive device (CuT 380A) (120 women). The mother and infant pairs were followed up at monthly intervals during the first three months and at two-month intervals thereafter up until the first birthday of the baby. No pregnancy occurred in the two groups. Amenorrhea was significantly more prolonged in the Uniplant group than in the IUD group. There were no significant differences in net continuation rates between the two groups (88.3 versus 92.4 per 100 women, respectively). There were no significant differences between the two groups in the number of breastfeeding episodes, time of weaning, and the cumulative rates of full and partial breastfeeding. There were no significant differences between the two groups in infant weight, weight gain per day, or in infant linear growth. There were no significant differences in the incidence of important health problems affecting the infants of the two groups. However, there were seven infant deaths, six of them were in the Uniplant group. Uniplant subdermal contraceptive implants can be offered as a new contraceptive option suitable for nursing mothers.

PIP: During November 1992-November 1994 at Assiut University Hospital in Egypt, 120 of 240 fully lactating women requesting contraception during the second postpartum month chose the nomegestrol acetate contraceptive subdermal implant Uniplant, while the other 120 chose the copper-releasing IUD CuT 380A. This prospective, non-randomized study evaluated the use of Uniplant during lactation. The mothers and their infants were followed-up once a month for 3 months and then every 2 months up to the infants' first birthday. Neither group experienced a pregnancy. Women in the Uniplant group were less likely to have resumed menstruation at 12 months postpartum than those in the IUD group (38% vs. 63%; p 0.001). The 12-month net continuation rates were statistically similar (88.3% for Uniplant users and 92.4% for IUD users). Reasons for IUD discontinuation were infant death (6), lost to follow up (5), irregular bleeding (2), and depression (1). Reasons for Uniplant discontinuation were lost to follow up (4), irregular bleeding (2), moving to a distant residence (2), and infant death (1). The 2 groups were similar in terms of breast feeding episodes, time of weaning, and the cumulative rates of full and partial breast feeding. Health problems (diarrhea, fever, and cough) affected the infants of both groups at similar incidence rates. The infants in both groups had similar weight, weight gain per day, and linear growth. Six of the 7 infant deaths occurred in the Uniplant group. The difference in the infant death rate was not significantly different, however. Gastroenteritis was responsible for 5 infant deaths. Bronchopneumonia and unexplained convulsion claimed the life of 1 infant each. These findings suggest that Uniplant is an acceptable and effective contraceptive method during lactation and has no adverse effect on infant growth and health.

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