Immediate vs. Delayed Postpartum Etonogestrel Implant

Phase 4

Completed

• Conditions: Continuation Rate of Contraceptive Implant
• Interventions: Drug: Etonogestrel implant

• Registration Number: NCT01767285
• Lead Sponsor: Duke University

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-01
• Study First Submitted: 2013-01-07
• Study First Submitted QC: 2013-01-10
• Study First Posted: 2013-01-14
• Primary Completion: 2015-04
• Study Completion: 2015-04
• Results First Submitted: 2016-03-30
• Results First Submitted QC: 2016-10-26
• Results First Posted: 2016-12-19
• Status Verified: 2017-01
• Last Update Submitted: 2017-01-13
• Last Update Posted: 2017-02-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 60

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.

Read More

Exclusion Criteria

1. Not meeting inclusion criteria

2. Use of chronic medical therapy that has an adverse interaction with etonogestrel. Medications that will be cause for exclusion from the study include:

3. 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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Immediate Postpartum Etonogestrel Implant	Etonogestrel implant	Etonogestrel implant placed in the hospital after delivery, before discharge home.
Delayed postpartum etonogestrel implant	Etonogestrel implant	These subjects will have the etonogestrel implant placed at the 6 week postpartum visit.

Primary Outcome Measures

Name	Time	Method
Continuation Rate	1 year	To identify a difference in continuation rates of Implanon® between women who have the device placed immediately postpartum and women who have the device placed at the 6-week postpartum visit.

Secondary Outcome Measures

Name	Time	Method
Rate of Intercourse	6 weeks	To identify differences in the rates of intercourse prior to the 6-week postpartum visit.
Continuation Rate	6 months	To identify a difference in continuation rates of Implanon® at one year between women who have the device placed immediately postpartum and women who have the device placed at the 6-week postpartum visit.

Trial Locations

Locations (1)

Duke University Medical Center; 🇺🇸 Durham, North Carolina, United States