A non-randomized comparative clinical trial of the progestin-only oral contraceptive (POC), Ovrette (75 mcg norgestrel) (Wyeth), versus non-hormonal methods was conducted at two clinics in Buenos Aires, Argentina. The trial was designed to assess the breast-feeding patterns of women choosing progestin-only oral contraception and non-hormonal methods of contraception, and to study the relationship between lactation and the clinical performance of a POC. Five-hundred women were allocated to either the progestin-only pill group (n = 250) or to the non-hormonal group (n = 250) and were followed up monthly for six months after admission. Measurements in mean infant weight, mean infant length, and mean head circumference were similar throughout the follow-up period. Non-hormonal users reported significantly more self-perceived decreases in milk production at the 5th and 6th month follow-up intervals. Acceptance and continued use of the pill were excellent, with only one woman discontinuing because of a pregnancy which was attributed to user failure. The principal side effect reported by women in both groups was intermenstrual bleeding.
PIP: A nonrandomized, comparative, clinical trial of the progestin only oral contraceptive (OC) Ovrette (75 mcg norgestrel) vs. nonhormonal methods was conducted at 2 clinics in Buenos Aires, Argentina. The trial was designed to assess breast-feeding patterns of women choosing progestin- only OCs and nonhormonal methods of contraception and to study the relationship between lactation and the clinical performance of the OC. 500 women were allocated to either the progestin-only pill group (n=250) or t o the nonhormonal group (n=250) and were followed monthly for 6 months after admission. Measurements in mean infant weight, mean infant length, and mean head circumference were similar throughout the follow- up period. Nonhormonal users reported significantly more self-perceived decreases in milk production at the 5th an 6th month follow-up intervals. Acceptance and continued use of the pill were excellent, with only 1 women discontinuing because of a pregnancy which was the result of user failure. The principal side effect reported by women in both groups was intermenstrual bleeding.