Clinical trial NCT01666912: Postpartum Etonogestrel Implant for Adolescents
Official title: Etonogestrel-releasing Subdermal Implant for Adolescents in the Postpartum Period: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Adolescence
Contraception
Postpartum
Keywords: adolescence
contraception
postpartum
rapid repeat pregnancy
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
First posted: 2012-08-16
Enrollment: 96
Sex: FEMALE
Minimum age (years): 14
Maximum age (years): 24
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: 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

Primary outcomes:
measure: Continuation at 1 Year
timeFrame: 12-14 months
Secondary outcomes:
measure: Satisfaction
timeFrame: 12 months
measure: Rapid Repeat Pregnancy
timeFrame: 12 months
Other outcomes:
Locations:
city: Chapel Hill
country: United States
facility: University of North Carolina Hospitals
state: North Carolina
Study officials:
References: