Phase 3 N=81 Randomized Prevention

Immediate Versus Delayed Insertion of Implanon in Postpartum Adolescents

Contraceptive Usage

Bottom Line

View on ClinicalTrials.gov: NCT03585504 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Oct 2018

Primary outcome: Primary: Number of Participants With Contraceptive Implant Continuation at Six Months Postpartum — 15; 7 Participants

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: Etonogestrel contraceptive implant (Drug)
Age: Pediatric, Adult · 15+ yrs
Sex: Female
Sponsor: Medical University of South Carolina
Primary completion: Jan 2013

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Participants With Contraceptive Implant Continuation at Six Months Postpartum	15; 7	—
SECONDARY Number of Participants That Reported They Were Somewhat or Very Satisfied With Their Subjective Bleeding Experience at Six Months Postpartum.	10; 8	—
SECONDARY Number of Participants Who Reported That They Were Somewhat or Very Satisfied With the Contraceptive Implant at Six Months Postpartum.	14; 6	—

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.

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03585504). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.