CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 200 enrolled
Drug / intervention
Nexplanon (etonogestrel contraceptive implant) +1 moredrug
Likely dose
Nexplanon (etonogestrel contraceptive implant) 68 mgfrom 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/NCT02657148
NCT02657148N/ACompleted
CompareCT.gov

A Prospective Observational Clinical Trial to Compare the Effect of Immediate Postpartum Nexplanon Placement Versus Standard Postpartum Contraceptive Care on Consistent Contraceptive Use and Rapid Repeat Pregnancy in Opioid Dependent Women.

University of Pittsburgh·observational·Posted Jan 15, 2016·Updated Aug 31, 2018

In Brief

An observational study evaluating Nexplanon (etonogestrel contraceptive implant) and Standard postpartum contraceptive care for Opiate Addiction and 3 related conditions. Completed, enrolled 200 participants across 1 site.

Detailed Summary

The investigators have designed a single site, Phase IV open label, prospective observational clinical trial to compare the effect of immediate postpartum Nexplanon placement (IPP) versus standard postpartum contraceptive care (control) on consistent contraceptive use and rapid repeat pregnancy at 12 months postpartum in 200 opioid dependent (OD) women.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
ConditionsOpiate Addiction, Pregnancy, Contraceptive Behavior, Sexual Behavior
CountriesUnited States
CollaboratorsMerck Sharp & Dohme LLC

Timeline

N/ACompletedFinished
20162017201820192020202120222023202420252026
First PostedJan 15, 2016
Enrollment StartMay 1, 2016
Primary CompletionAug 1, 2018
TodayJul 2, 2026
Enrollment to primary: 2.3 yearsPosted 10.5 years ago

Interventions

Nexplanon (etonogestrel contraceptive implant)drug

Nexplanon is a single, radiopaque, rod-shaped implant, containing 68 mg etonogestrel indicated for postpartum contraceptive use by women to prevent pregnancy. Nexplanon is designed to be effective for 3 years.

Standard postpartum contraceptive caredrug

Condoms, Depo Provera (DMPA) or progestin-only pills initiated at any time after delivery, Nexplanon insertion at \> 4 weeks after delivery, combined hormonal contraception (e. g. pills, patch, ring) initiated at any time \> 4 weeks after delivery or levonorgestrel-intrauterine system or copper IUD insertion any time \> 6 weeks after delivery.