Immediate Versus Delayed Insertion of Implanon in Postpartum Adolescents

NCT03585504 | Completed Phase 3 Results FDA Drug

• 1 other identifier: HR #19133
• Study Type: interventional
• Target: 81
• Locations: 1 country
• Sites: 1

Brief Summary

The specific aim of this study is to evaluate whether insertion of a long-acting contraceptive implant in postpartum adolescents prior to hospital discharge increases use of this highly effective contraception during the first twelve months postpartum among adolescents who elect Implanon® as their preferred method of contraception. Additionally, this study aims to compare the acceptability of bleeding in postpartum adolescents who have an etonogestrel contraceptive implant prior to discharge versus those with insertion at the six week postpartum visit. The investigators will evaluate the acceptability of bleeding rather than collect prospective diaries because the investigators feel subjective perceptions of bleeding impact contraceptive continuation more than quantitative differences in bleeding.

Conditions

Contraceptive Usage

Keywords

Implanon; Bleeding Acceptability; Contraceptive Implant; Adolescent Pregnancy Prevention; Post Partum Insertion of Implanon

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Contraceptive Implant Continuation at Six Months Postpartum

  We compare the number of participants continuing the implant at six months in each group.

  6 months

Secondary Outcomes (2)

• Number of Participants That Reported They Were Somewhat or Very Satisfied With Their Subjective Bleeding Experience at Six Months Postpartum.

  6 months

• Number of Participants Who Reported That They Were Somewhat or Very Satisfied With the Contraceptive Implant at Six Months Postpartum.

  6 months

Study Arms (2)

Intervention group

EXPERIMENTAL

Patients will undergo etonogestrel contraceptive implant insertion prior to hospital discharge per package instructions.

Drug: Etonogestrel contraceptive implant

Control Group

ACTIVE COMPARATOR

These patients will receive an appointment to undergo etonogestrel contraceptive implant insertion at the postpartum visit occuring approximately six weeks after delivery as is standard care in our institution.

Drug: Etonogestrel contraceptive implant

Interventions

Etonogestrel contraceptive implant DRUG

Etonogestrel contraceptive implant

Control Group; Intervention group

Eligibility Criteria

• Age: 15 Years - 21 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• ages 15-21
• women
• english or spanish speaking
• less than 120 hours post partum

You may not qualify if:

• women who are breastfeeding
• contraindications to Implanon® insertion including current or prior thrombo-embolic disease, liver disease, hypersensitivity to components of Implanon®, or are using medications such as rifampin, phenytoin, or carbamazepine that increase metabolism of steroid hormones.
• indicate unwillingness to continue follow-up for one year.

Sponsors & Collaborators

• Medical University of South Carolina: lead
• American College of Obstetricians and Gynecologists: collaborator
• Bayer: collaborator

Study Sites (1)

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

Related Publications (1)

• Sothornwit J, Kaewrudee S, Lumbiganon P, Pattanittum P, Averbach SH. Immediate versus delayed postpartum insertion of contraceptive implant and IUD for contraception. Cochrane Database Syst Rev. 2022 Oct 27;10(10):CD011913. doi: 10.1002/14651858.CD011913.pub3.

  PMID: 36302159 DERIVED

MeSH Terms

Conditions

Contraception Behavior

Condition Hierarchy (Ancestors)

Reproductive Behavior; Behavior

Results Point of Contact

• Title: Dr. Angela Dempsey
• Organization: Medical University of South Carolina

dempsear@musc.edu

843-762-4500

Study Officials

• Angela Dempsey, MD

  Medical University of South Carolina

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: participants were randomized to receive a contraceptive implant before hospital discharge or at their six week postpartum visit

Study Record Dates

• First Submitted: May 10, 2018
• First Posted: July 13, 2018
• Study Start: January 1, 2010
• Primary Completion: January 1, 2013
• Study Completion: January 1, 2013
• Last Updated: October 4, 2018
• Results First Posted: October 4, 2018

Record last verified: 2018-10

Locations

US (1)