Postpartum Etonogestrel Implant for Adolescents

University of North Carolina, Chapel Hill96 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

Conditions

Adolescence Contraception Postpartum

Interventions

Eligibility

Sex: FEMALEMin age: 14 YearsMax age: 24 YearsHealthy volunteers:

Medical Language ↔ Plain English

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. 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

Outcomes

Primary Outcomes

Continuation at 1 Year

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.

Time frame: 12-14 months

Secondary Outcomes

Satisfaction

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."

Time frame: 12 months

Rapid Repeat Pregnancy

To assess rapid repeat pregnancies among the study population, ie, the number of participants who reported a repeat pregnancy within 12 months postpartum.