The Effect of Hormonal Contraceptives on Breast-milk Production and Infant Growth
Status:
Completed
Trial end date:
2011-08-01
Target enrollment:
Participant gender:
Summary
The investigators propose a randomized clinical trial comparing the effect of 30 mcg ethinyl
estradiol and LNG 150 combination oral contraceptive pills versus placebo, or LNG-IUS or
Etonogestrel-releasing contraceptive implant (Implanon)on breast-milk intake and infant
growth in exclusively breastfeeding mother-infant pairs. Mother-infant pairs will be randomly
assigned either 30 microgram ethinyl estradiol combination oral contraceptive pills or
identical placebo to start on post-partum day number 42 or Implanon implants or a LNG-IUS.
All women will be offered nonhormonal contraceptives prior to randomization. The pairs will
then be followed for four weeks. During this follow-up period, breast-milk intake will be
quantified by administering deuterium oxide to exclusively breast-feeding mothers and
measuring the enrichment of deuterium oxide in the saliva of their infants, otherwise known
as the dose-to-mother method of Coward.17 Additionally, maternal and infant anthropometric
measurements will be collected -- both as a value necessary to implement the breast-milk
quantification method, as well as an outcome for analysis, and a daily diary will be kept by
the women participating in the study that records infant feeds and diaper changes.
Phase:
Phase 4
Details
Lead Sponsor:
University of Campinas, Brazil
Collaborator:
Fundação de Amparo à Pesquisa do Estado de São Paulo