Postpartum Etonogestrel Implant for Adolescents
Condition: Adolescence; Contraception; Postpartum
Intervention: Contraceptive implant
Intervention MeSH terms: Contraceptive Agents; Etonogestrel
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 96.0
Sex: Female
Minimum age: 14 Years
Maximum age: 24 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: adolescence; contraception; postpartum; rapid repeat pregnancy

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