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Immediate Postpartum Nexplanon Placement in Opioid Dependent Women

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ClinicalTrials.gov Identifier: NCT02657148
Recruitment Status : Completed
First Posted : January 15, 2016
Last Update Posted : August 31, 2018
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Elizabeth Krans, MD, 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.

Condition or disease Intervention/treatment
Opiate Addiction Pregnancy Contraceptive Behavior Sexual Behavior Drug: Nexplanon (etonogestrel contraceptive implant) Drug: Standard postpartum contraceptive care

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


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Study Type : Observational
Actual Enrollment : 200 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: 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.
Actual Study Start Date : May 2016
Actual Primary Completion Date : August 2018
Actual Study Completion Date : August 2018

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Immediate postpartum Nexplanon
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)
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.
Other Name: Nexplanon

Control
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
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.
Other Name: Postpartum contraception




Primary Outcome Measures :
  1. Consistent contraception [ Time Frame: 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 :
  1. Rapid, repeat pregnancy [ Time Frame: 12 months postpartum ]
    Number of participants who have a repeat pregnancy within 12 months after delivery

  2. Breastfeeding initiation [ Time Frame: 12 months postpartum ]
    Number of participants who breastfeed after delivery

  3. Postpartum depression [ Time Frame: 12 months postpartum ]
    Edinburgh Postnatal Depression Scale scores

  4. Infant weight gain [ Time Frame: 12 months ]
    Infant weight in kilograms

  5. Infant development [ Time Frame: 12 months ]
    Number of infants that achieve developmental milestones

  6. High-risk sexual behavior [ Time Frame: 12 months ]
    Number of participants who use condoms



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
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).
Criteria

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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02657148


Locations
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United States, Pennsylvania
Magee-Womens Hospital of UPMC
Pittsburgh, Pennsylvania, United States, 15213
Sponsors and Collaborators
University of Pittsburgh
Merck Sharp & Dohme Corp.
Investigators
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Principal Investigator: Elizabeth E Krans, MD, MSc University of Pittsburgh

Publications:

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Responsible Party: Elizabeth Krans, MD, Assistant Professor, Department of Obstetrics, Gynecology & Reproductive Sciences, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT02657148     History of Changes
Other Study ID Numbers: PRO15070357
IIS#53505 ( Other Grant/Funding Number: Merck Women's Health MISP-RC )
First Posted: January 15, 2016    Key Record Dates
Last Update Posted: August 31, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
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Opioid-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Contraceptive Agents
Etonogestrel
Desogestrel
Reproductive Control Agents
Physiological Effects of Drugs
Contraceptive Agents, Female
Contraceptives, Oral, Synthetic
Contraceptives, Oral
Progestins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists