Our long-term goal is to determine the safety of progestin-only contraception initiated immediately postpartum among breastfeeding mothers. For many breastfeeding women, progestin-only contraception is the only possible method for highly-effective protection. Contraceptive steroids have been detected in breast milk, raising theoretical concerns that early postpartum exposure to progestin could pose health concerns to the infant. Studies in humans have not identified substantial effects from this exposure either on infant growth and development or on lactogenesis in the mother. However, these studies are limited by methodologic issues and low power. Given the hypothetical risks to the infant, the World Health Organization advises against the use of progestin-only contraception during the first six weeks postpartum among breastfeeding women. In contrast, the Centers for Disease Control and Prevention recommends that the advantages of progestin-only methods generally outweigh their risks. This inconsistency between agencies stems from the lack of quality data upon which to form evidence-based guidelines.
We propose to collect preliminary data to support the development of future NIH R21 and R01 applications to study the safety of progestin-only contraception during the immediate postpartum period among breastfeeding women. All preliminary data supported by the seed grant funding will be collected at The Ohio State University Wexner Medical Center in Columbus, Ohio. Specifically, we propose to conduct 1) a retrospective chart review for the past 12 months and 2) a cross-sectional study of a convenience sample of 100 postpartum women who will be interviewed before their hospital discharge. Eligibility for the cross-sectional study will be restricted to postpartum women at the study site who delivered a term, healthy infant of ≥2500 grams, intend to nurse for ≥6 months, and provide written consent for participation. A trained interviewer will administer the cross-sectional survey and record participant responses directly into REDCap software. The two preliminary studies will address three specific aims: 1) Establish the adequacy of the caseload of the target population for the future research. 2) Determine contraceptive prevalence and knowledge among the target population for the future research. 3) Assess the hypothetical willingness of women to participate in the future research using the planned trial design.
Publications resulting from this seed grant
2017. Loewenberg Weisband Y, Keim SA, Keder LM, Geraghty SR, Gallo MF. "Early breast milk pumping intentions among postpartum women" Breastfeed Med. 2017 Jan/Feb;12:28-32. PMCID: PMC5220526