drugset / Trial / NCT00847587

Early Versus Standard Postpartum Insertion of the Etonogestrel Contraceptive Implant

NCT00847587

Phase 4 Completed 69 enrolled University of Utah
RandomizedParallel-groupOpen-labelTreatment

Summary

A highly effective single rod contraceptive implant is now available for use in the US. Delays in the insertion of the device until later in the postpartum period may negatively impact initiation rates. The objective of this study is to compare outcomes of early postpartum insertion (prior to postpartum hospital discharge) of the etonogestrel-releasing contraceptive implant with routine postpartum insertion at 4-8 weeks after delivery. Primary outcome of interest will be time to lactogenesis. Secondary outcomes will include rates of breastfeeding supplementation, infant growth, vaginal bleeding patterns, incidence of side effects, time to resume sexual intercourse after delivery, and incidence of missed routine postpartum follow-up. In addition, a subset of patients who randomize to early postpartum insertion will have expressed breastmilk ascertained for nutrient composition.

Timeline

Start
2009-01
Primary completion
2009-12
Completion
2010-05

Drugs

EvaluationDrugModalityDoseRoute
Comparator Etonogestrel Unknown

Indications