Postpartum Etonogestrel Implant for Adolescents
This trial is active, not recruiting.
|Conditions||adolescence, contraception, postpartum|
|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.
|Intervention model||parallel assignment|
Continuation at 1 year
time frame: 18 months
time frame: 12 months
Rapid repeat pregnancy
time frame: 12 months
Female participants from 14 years up to 24 years old.
- 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.
- 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
|Official title||Etonogestrel-releasing Subdermal Implant for Adolescents in the Postpartum Period: a Randomized Controlled Trial|
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