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Immediate Postpartum Nexplanon Placement in Opioid Dependent Women

NCT02657148 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 200

Last updated 2018-08-31

No results posted yet for this study

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.

Conditions

  • Opiate Addiction
  • Pregnancy
  • Contraceptive Behavior
  • Sexual Behavior

Interventions

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.

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.

Sponsors & Collaborators

Principal Investigators

  • Elizabeth E Krans, MD, MSc · University of Pittsburgh

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-05-31
Primary Completion
2018-08-31
Completion
2018-08-31

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02657148 on ClinicalTrials.gov