Postpartum Etonogestrel Implant for Adolescents

Phase 4

Completed

• Conditions: Adolescence; Postpartum; Contraception
• Interventions: Drug: Contraceptive implant

• Registration Number: NCT01666912
• Lead Sponsor: University of North Carolina, Chapel Hill

Brief Summary

This is a prospective study comparing two groups of 48 adolescent women each. The intervention group will receive a contraceptive implant postpartum, prior to discharge from the hospital. The control group will receive a contraceptive implant at the usual 6 week postpartum clinic visit. During prenatal care, participants will be consented and screened for enrollment. After delivery, these women will be assessed and consented for enrollment into the study. Women who consent for enrollment will be randomized. Women will be followed up at 3 months, 6 months, 9 months, and 1 year after contraceptive implant insertion. At each follow up, women will be assessed for continuation of and satisfaction with this method of contraception.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-08
• Study First Submitted: 2012-08-14
• Study First Submitted QC: 2012-08-14
• Study First Posted: 2012-08-16
• Primary Completion: 2015-04
• Study Completion: 2015-04
• Results First Submitted: 2017-01-13
• Status Verified: 2017-03
• Results First Submitted QC: 2017-03-20
• Last Update Submitted: 2017-03-20
• Results First Posted: 2017-05-01
• Last Update Posted: 2017-05-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 96

Inclusion Criteria

• Adolescents ages 14-24 attending prenatal care
• Greater than 20 weeks estimated gestational age
• English or Spanish-speaking
• Desire to use the contraceptive implant for contraception postpartum
• Anticipated delivery of a healthy infant vaginally or by cesarean.

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Exclusion Criteria

Participants will not be eligible for participation if they have any contraindications to contraceptive implant use, including

• current or past history of thrombosis or thromboembolic disorders
• hepatic tumors (benign or malignant)
• active liver disease
• undiagnosed abnormal genital bleeding
• known or suspected carcinoma of the breast (or a personal history of breast cancer)
• hypersensitivity to any of the components of the contraceptive implant.
• Current use of any medications known to induce hepatic enzymes, including but not limited to: barbiturates, bosentan, carbamazepine, felbamate, griseofulvin, oxcarbazepine, phenytoin, rifampin, St. John's wort, or topiramate

Characteristics that would preclude involvement after delivery:

• Birth of a stillborn infant.
• Maternal ICU admission after delivery
• Maternal postpartum hemorrhage requiring blood transfusion
• Prolonged hospital stay (>7 days) postpartum
• Coagulopathy associated with the pregnancy
• Severe pregnancy-induced hypertension
• Fever >38 degrees C postpartum
• Adolescent women who are not competent to consent, secondary to stress from the labor process, for example severe pain or sleep deprivation, will not be offered enrolment into the trial

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
6 week postpartum contraceptive implant	Contraceptive implant	randomized to receive contraceptive implant at normal 6 week postpartum visit
Immediate postpartum contraceptive implant	Contraceptive implant	randomized to receive contraceptive implant prior to leaving the hospital postpartum

Primary Outcome Measures

Name	Time	Method
Continuation at 1 Year	12-14 months	The number of participants using the contraceptive implant at one year postpartum among women who have the implant placed immediately postpartum vs. at 6 weeks postpartum.

Secondary Outcome Measures

Name	Time	Method
Satisfaction	12 months	To assess satisfaction with the contraceptive implant inserted in the postpartum period, using a scale of 0-10, with 0 being "not satisfied at all" to 10 being "extremely satisfied."
Rapid Repeat Pregnancy	12 months	To assess rapid repeat pregnancies among the study population, ie, the number of participants who reported a repeat pregnancy within 12 months postpartum.

Trial Locations

Locations (1)

University of North Carolina Hospitals; 🇺🇸 Chapel Hill, North Carolina, United States