Immediate Postpartum Nexplanon Placement in Opioid Dependent Women

Study Overview
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Brief Summary
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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
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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

Official Title
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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.

Conditions
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Opiate Addiction, Pregnancy, Contraceptive Behavior, Sexual Behavior

Intervention / Treatment
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* Drug: Nexplanon (etonogestrel contraceptive implant)
* Drug: Standard postpartum contraceptive care


Participation Criteria
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Eligibility Criteria
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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). 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Immediate postpartum Nexplanon<br>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. | Drug: Nexplanon (etonogestrel contraceptive implant)<br>* 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.<br>* Other names: Nexplanon;|
| Control<br>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. | Drug: Standard postpartum contraceptive care<br>* 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.<br>* Other names: Postpartum contraception;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Consistent contraception | Number of participants who use highly effective contraception (all hormonal methods or the copper T380 IUD) for ≥ 80% of the first postpartum year | 12 months postpartum | 

Secondary Outcome Measures

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