Lactogenesis and breastfeeding continuation in immediate vs. delayed postpartum contraceptive implant insertion: An RCT
Awarded 2019
Complex Family Planning Fellowship Research
Maritza Rivera Montalvo, MD
University of New Mexico Health Sciences Center

The Lacto-Rod study is a research project that seeks to comprehend the effect of the etonogestrel implant hormonal contraceptive on breastfeeding when it is initiated early in the postpartum period. The planned non-inferiority randomized controlled trial (RCT)  will enroll women who plan to deliver at the University of New Mexico Hospital, who want to use the implant as a contraceptive and don’t have any contraindication to use of the etonogestrel implant. Women will be counseled regarding risks and benefits of contraceptive options as per usual institutional practice. Patients who express interest in the implant as a contraceptive method will be referred to a member of the research team to discuss the study.  After deciding on an implant women may be approached 1) during the antepartum period, 2)  they arrive to LandD, not in active labor, and 3) during the postpartum course prior to hospital discharge.  At any of these points, the patient may be counseled about the study, consented and enrolled. Participants will be randomized after delivery prior to discharge home using centrally located computer-generated randomization.  Both groups will have the same protocol for follow-up and data collection.  Patients randomized to the immediate insertion group will have the implant inserted during the first 24-48 hours after delivery. If the patient is randomized to delayed postpartum insertion, she will be given a clinic appointment in 4-6 weeks for the insertion procedure.
Lactogenesis will be collected by maternal perception as per previously validated scale. Those women who have not experienced lactogenesis prior to hospital discharge will be contacted with daily phone calls until lactogenesis occurs. Also, every patient will have a logbook to record breastfeeding parameters including side effects, the method of breastfeeding (exclusive, mixed, bottle feeding either with formula or breast milk, discontinuation reason, date of breastfeeding discontinuation and contraceptive continuation) for the study follow-up period.  Patients will be called every 2 weeks up to 12 weeks to verify continuing breastfeeding or the time of stopping it, and then at 24 weeks.  The data will be collected and processed in RedCap.