Immediate Postpartum Nexplanon Placement in Opioid Dependent Women

Status Completed

Clinical Trial 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.

Clinical Trial Description

Background: Opioid dependence in pregnancy has increased dramatically in the last decade. Over 86% of pregnancies conceived by OD women are unintended, compared to 31-43% of pregnancies in the general population. In evaluations of contraceptive use among sexually active women in opioid treatment programs, 40-75% of sexually active OD women report no contraceptive use. Even among women using contraception, 45-55% report using only condoms without more effective, hormonal contraception. Pregnancy and the postpartum period are unique opportunities to provide contraceptive education and services. Long-acting reversible contraception (LARC) has been shown to more effectively prevent rapid repeat, unintended pregnancies compared to other postpartum contraceptive options and does not incur the risk of venous thromboembolism associated with estrogen-containing methods (i.e. pills, ring, patch). No studies have evaluated the impact of immediate postpartum etonogestrel implant (Nexplanon) placement on reproductive health outcomes in OD women, a population at significant risk for rapid repeat, unintended pregnancy. In contrast to an intrauterine device (IUD), Nexplanon is safe to insert regardless of labor and delivery circumstances, does not incur an increased risk of postpartum expulsion and is long-acting, which makes it the ideal contraceptive for the immediate postpartum period.

Study site:This single site study will be conducted at Magee-Womens Hospital (MWH) of the University of Pittsburgh Medical Center.

Study Procedures: Recruitment - participants will be recruited during the third trimester of pregnancy (≥ 28 weeks gestation) during prenatal care visits.

Immediate postpartum Nexplanon placement (IPP) - participants who choose to enroll in the IPP Nexplanon arm will have Nexplanon placed in the immediate postpartum period (2-4 days following delivery), prior to hospital discharge.

Standard postpartum contraceptive care (control) - participants who choose to enroll in the control arm will receive a contraceptive method of their choice according to standard clinical protocols. Standard clinical protocols include 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.

Study Duration: 12 months ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT02657148
Study type	Observational
Source	University of Pittsburgh
Contact
Status	Completed
Phase
Start date	May 2016
Completion date	August 2018

View Details

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