Immediate vs. Delayed Postpartum Etonogestrel Implant

Duke University

Status and phase: Completed; Phase 4

Conditions: Continuation Rate of Contraceptive Implant

Treatments: Drug: Etonogestrel implant

Study type: Interventional

Funder types: Other

Identifiers

NCT01767285

Pro00030001

Details and patient eligibility

About

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.

Enrollment: 60 patients

Sex: Female

Ages: 12 to 40 years old

Volunteers: Accepts Healthy Volunteers

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

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

Immediate Postpartum Etonogestrel Implant

Experimental group

Description:

Etonogestrel implant placed in the hospital after delivery, before discharge home.

Treatment:

Drug: Etonogestrel implant

Delayed postpartum etonogestrel implant

Active Comparator group

Description:

These subjects will have the etonogestrel implant placed at the 6 week postpartum visit.

Treatment:

Drug: Etonogestrel implant