Contraceptives for lactating women: A comparative trial of a progesterone-releasing vaginal ring and the Copper T 380A IUD
Sivin,Irving; Diaz,Soledad; Croxatto,Horacio B.; Miranda,Patricia; Shaaban,Mamdouh; Sayed,Ezzat H.; Xiao,Bilian; Wu,Shang-Chun; Du Ming-kun; Alvarez-Sanchez,Francisco; Brache,Vivian; Basnayake,Sriani; McCarthy,Terence; Lacarra,Maria; Mishell,Daniel R.,Jr.; Koetsawang,Suporn; Stern,Janet; Jackanicz,Theodore M.
Contraception 55(4): 225-232
Publication date: 1997
From approximately one week before normal ovulation resumes, lactating women require protection against pregnancy by a contraceptive that is safe for both infant and mother. In a multicenter one-year study, the natural hormone, progesterone, delivered vaginally by a sequence of four contraceptive rings designed for continuous use, was evaluated as a contraceptive for nursing mothers in comparison with the Copper T 380A IUD. Individual rings release an effective average dose of 10 mg/day for a 3-month period. Evaluation included measures of lactational performance as well as of contraceptive efficacy and safety to mother and child. Nine participating clinics enrolled 802 ring users and 734 IUD acceptors between postpartum days 29 and 63. Life table analyses were performed with parallel decrements for ring and IUD subjects. Continuation in the study and analysis required that subjects not stop breastfeeding. The ring, with a one-year pregnancy rate of 1.5 per 100, did not differ significantly from the IUD with respect to contraceptive effectiveness (p > 0.05). More than half of the ring subjects were continuing at 6 months post admission and a quarter (23.5 per hundred) were still using the ring and breastfeeding one year after admission. Women with the IUD, however, had higher continuation rates (p < 0.001) at both time points. The largest single decrement for each method was that for weaning. Ring users had more complaints of vaginal problems but had fewer vaginal disorders on examination. At 12 months postpartum, 46 per 100 continuing ring users remained in amenorrhea. Lactation performance and the health and weight gain of the infants were similar among users of either regimen.