Postpartum Etonogestrel Implant for Adolescents
| Status: | Completed |
|---|---|
| Conditions: | Contraception |
| Therapuetic Areas: | Reproductive |
| Healthy: | No |
| Age Range: | 14 - 24 |
| Updated: | 5/5/2014 |
| Start Date: | August 2012 |
| End Date: | February 2014 |
| Contact: | Amy G Bryant, MD, MSCR |
| Email: | amy_bryant@med.unc.edu |
| Phone: | 919-843-6473 |
Etonogestrel-releasing Subdermal Implant for Adolescents in the Postpartum Period: a Randomized Controlled Trial
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 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.
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
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