ABSTRACT
The objective was to compare the effects of Exluton with those of Multiload Cu250, in an open-label, bi-center, randomized study in breastfeeding women. Subjects were randomized to one of the treatment groups 6 weeks after delivery. Women and their infants returned to the study site monthly and follow-up data regarding qualitative and quantitative characteristics of the breast milk, infant growth and infant and maternal health were obtained. There were no statistically significant differences between groups with regard to: (1) amount of milk drunk, amount of milk production, and number of daily breastfeedings; (2) mean milk concentrations of nutritional constituents (except higher milk levels of calcium and magnesium with Exluton during the first month); (3) infant anthropometric parameters. There were no between-group differences with regard to systolic or diastolic blood pressure. During the study, the mean maternal body weight in the Exluton group was significantly lower than in the Multiload Cu250 group. There were no differences between groups with regard to child or maternal health, except a lower incidence of child illness after 6 months in the Exluton group. This study confirms that both Exluton and Multiload Cu250 are acceptable and safe contraceptive methods in breastfeeding women.
