CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 69 enrolled
Drug / intervention
Etonogestrel contraceptive implant +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00847587
NCT00847587Phase 4Completed

Randomized Controlled Trial of Early Versus Standard Postpartum Insertion of the Etonogestrel Contraceptive Implant

University of Utah·interventional·Posted Feb 19, 2009·Updated Apr 18, 2016

In Brief

A Phase 4 clinical trial evaluating Etonogestrel contraceptive implant for Complications; Contraceptive and Female Lactation. Completed, enrolled 69 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

Phase 4CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedFeb 19, 2009
Enrollment StartJan 1, 2009
Primary CompletionDec 1, 2009
Study CompletionMay 1, 2010
TodayJul 2, 2026
Enrollment to primary: 11 monthsPosted 17.4 years ago

Interventions

Etonogestrel contraceptive implantdrug

Implant insertion postpartum prior to hospital discharge

Etonogestrel contraceptive implantdrug

Standard insertion at 4-8 weeks postpartum