Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-26 @ 11:10 AM
Ignite Modification Date:
2025-12-26 @ 11:10 AM
NCT ID:
NCT01666912
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
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
14 Years
Maximum Age:
24 Years
Study:
NCT01666912
Study Brief:
Protocol Section:
NCT01666912