Phase 4 N=59 Randomized Prevention

Immediate vs. Delayed Postpartum Etonogestrel Implant

Continuation Rate of Contraceptive Implant

Bottom Line

View on ClinicalTrials.gov: NCT01767285 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Dec 2016

Primary outcome: Primary: Continuation Rate — 20; 18 participants

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: Etonogestrel implant (Drug)
Age: Pediatric, Adult · 12+ yrs
Sex: Female
Sponsor: Duke University
Primary completion: Apr 2015

Outcome Measures

Outcome	Result	p-value
PRIMARY Continuation Rate	27; 21	—
SECONDARY Rate of Intercourse	8; 14	—
SECONDARY Continuation Rate	27; 21	—

Summary

The investigators are examining if there is a difference in continuation rates of the etonogestrel contraceptive implant between women who have the device placed immediately after delivery, before leaving the hospital, and women who have the device placed at the routine 6-week postpartum visit. There will be 60 subjects total, randomized in a 1:1 ratio, for 30 in each group. All participants will follow-up at the same postpartum clinic 6 weeks after delivery. They will then be contacted at 3, 6, and 12 months postpartum and asked to complete a brief survey. The investigators hypothesize that continuation rates of Implanon will be higher in the immediate postpartum placement arm than in the delayed placement arm.

Eligibility Criteria

Inclusion Criteria

1)Age 12-40 years 2)Must deliver at Duke Hospital 3)Must have a working telephone number 4)No contraindications to receiving this method of contraception, which include: known or suspected pregnancy, active liver disease or hepatic tumor, current or past history of thrombosis or thromboembolic disorder, undiagnosed abnormal genital bleeding, known or suspected breast cancer or history of breast cancer, hypersensitivity to any of the components of the device.

Exclusion Criteria

Not meeting inclusion criteria
Use of chronic medical therapy that has an adverse interaction with etonogestrel. Medications that will be cause for exclusion from the study include:
Non-nucleoside reverse transcriptase inhibitors 2. ritonavir-boosted protease inhibitors 3. Certain anticonvulsants - phenytoin, carbamazepine, barbiturates, primidone, topiramate, oxcarbazepine 4. Rifampin 5. St. John's Wort

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01767285). 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.