This trial is active, not recruiting.

Conditions adolescence, contraception, postpartum
Treatment contraceptive implant
Phase phase 4
Sponsor University of North Carolina, Chapel Hill
Start date August 2012
End date April 2015
Trial size 96 participants
Trial identifier NCT01666912, PPI-12-0732


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking open label
Primary purpose prevention
(Active Comparator)
randomized to receive contraceptive implant at normal 6 week postpartum visit
contraceptive implant Implanon, Nexplanon, etonogestrel contraceptive implant
randomized to receive contraceptive implant prior to leaving the hospital postpartum
contraceptive implant Implanon, Nexplanon, etonogestrel contraceptive implant

Primary Outcomes

Continuation at 1 year
time frame: 18 months

Secondary Outcomes

time frame: 12 months
Rapid repeat pregnancy
time frame: 12 months

Eligibility Criteria

Female participants from 14 years up to 24 years old.

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

Additional Information

Official title Etonogestrel-releasing Subdermal Implant for Adolescents in the Postpartum Period: a Randomized Controlled Trial
Trial information was received from ClinicalTrials.gov and was last updated in July 2014.
Information provided to ClinicalTrials.gov by University of North Carolina, Chapel Hill.