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OBJECTIVE: : To evaluate lactogenesis after early postpartum insertion of the etonogestrel contraceptive implant. METHODS: : Healthy peripartum women with healthy term newborns who desired the etonogestrel implant for contraception were randomly assigned to early (1-3 days) or standard (4-8 weeks) postpartum insertion. The primary outcomes time to lactogenesis stage II and lactation failure were documented by a validated measure. The noninferiority margin for the mean difference in time to lactogenesis stage II was defined as 8 additional hours. Secondary data (device continuation and contraceptive use breast milk analysis supplementation rates side effects and bleeding patterns) were collected at periodic intervals for 6 months. RESULTS: : Sixty-nine women were enrolled. Thirty-five were randomly assigned to early insertion and 34 to standard insertion. There were no statistically significant differences between the groups in age race parity mode of delivery use of anesthesia or prior breastfeeding experience. Early insertion was demonstrated to be noninferior to standard insertion in time to lactogenesis stage II (early: [mean+/-standard deviation] 64.3+/-19.6 hours; standard: 65.2+/-18.5 hours mean difference -1.4 hours 95% confidence interval [CI] -10.6 to 7.7 hours). Early insertion was also demonstrated to be noninferior to standard insertion in incidence of lactation failure (1/34 [3%] in the early insertion group 0/35 [0%] in the standard insertion group [risk difference 0.03 95% CI -0.02 to 0.08]). Use of formula supplementation was not significantly different between the groups. Milk composition at 6 weeks was not significantly different between the groups. CONCLUSION: : Breastfeeding outcomes were similar in women who underwent early compared with standard postpartum insertion of the etonogestrel implant. CLINICAL TRIAL REGISTRATION: : ClinicalTrials.gov www.clinicaltrials.gov NCT00847587. LEVEL OF EVIDENCE: : I.

The Manufacturer and User Facility Device Experience (MAUDE) database represents a reporting system mandated by the Food and Drug Administration for postmarket surveillance. MAUDE has been made into a searchable online database that includes all reported events in which medical devices may have malfunctioned or caused a death or serious injury. For the clinician considering the use of a new medical device, searching the MAUDE database is useful to search for complications not yet reported in the medical literature.