Postpartum Etonogestrel Implant for Adolescents

Completed · Phase 4

Conditions studied: Adolescence, Contraception, Postpartum

In brief

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.

Key facts

Study ID

NCT01666912

Run by

University of North Carolina, Chapel Hill

People needed

96

Starts

2012-08-01

Expected to finish

2015-04-01

Last updated by the study team

2017-05-01

Who can join

Age: 14 and older, up to 24. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• University of North Carolina Hospitals — Chapel Hill, North Carolina, United States

Full record on ClinicalTrials.gov

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