Immediate Postpartum Nexplanon Placement in Opioid Dependent Women

Completed

• Conditions: Opiate Addiction; Pregnancy; Contraceptive Behavior; Sexual Behavior
• Interventions: Drug: Nexplanon (etonogestrel contraceptive implant); Drug: Standard postpartum contraceptive care

• Registration Number: NCT02657148
• Lead Sponsor: University of Pittsburgh

Brief 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.

Detailed 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 Timeline

• Study First Submitted: 2015-09-21
• Study First Submitted QC: 2016-01-13
• Study First Posted: 2016-01-15
• Study Start: 2016-05
• Status Verified: 2018-08
• Primary Completion: 2018-08
• Study Completion: 2018-08
• Last Update Submitted: 2018-08-30
• Last Update Posted: 2018-08-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 200

Inclusion Criteria

Pregnant women, 18 years or older, who meet DSM-V criteria for opioid use disorder confirmed by diagnostic coding in the patient's medical record and/or urinary toxicology screen (UDS) and who plan to deliver at the study site hospital, Magee-Womens Hospital of UPMC (MWH-UPMC).

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Exclusion Criteria

Women who have contraindications to etonogestrel use, intrauterine fetal demise or stillbirth, and/or who do not plan to deliver at MWH-UPMC.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Immediate postpartum Nexplanon	Nexplanon (etonogestrel contraceptive implant)	Participants who choose to enroll in the immediate postpartum Nexplanon arm will have a etonogestrel contraceptive implant (68 mg) (Nexplanon) placed in the immediate postpartum period (2-4 days following delivery), prior to hospital discharge.
Control	Standard postpartum contraceptive care	Participants who choose to enroll in the control arm will receive standard postpartum contraceptive care: 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.

Primary Outcome Measures

Name	Time	Method
Consistent contraception	12 months postpartum	Number of participants who use highly effective contraception (all hormonal methods or the copper T380 IUD) for ≥ 80% of the first postpartum year

Secondary Outcome Measures

Name	Time	Method
Breastfeeding initiation	12 months postpartum	Number of participants who breastfeed after delivery
High-risk sexual behavior	12 months	Number of participants who use condoms
Rapid, repeat pregnancy	12 months postpartum	Number of participants who have a repeat pregnancy within 12 months after delivery
Postpartum depression	12 months postpartum	Edinburgh Postnatal Depression Scale scores
Infant weight gain	12 months	Infant weight in kilograms
Infant development	12 months	Number of infants that achieve developmental milestones

Trial Locations

Locations (1)

Magee-Womens Hospital of UPMC; 🇺🇸 Pittsburgh, Pennsylvania, United States