Postpartum Etonogestrel Implant for Adolescents

NCT ID: NCT01666912

Last Updated: 2017-05-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 96 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-08-31
• Study Completion Date: 2015-04-30

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.

Conditions

Adolescence; Contraception; Postpartum

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

6 week postpartum contraceptive implant

randomized to receive contraceptive implant at normal 6 week postpartum visit

Group Type: ACTIVE_COMPARATOR

Contraceptive implant

Intervention Type: DRUG

Immediate postpartum contraceptive implant

randomized to receive contraceptive implant prior to leaving the hospital postpartum

Group Type: EXPERIMENTAL

Contraceptive implant

Intervention Type: DRUG

Interventions

Contraceptive implant

Intervention Type: DRUG

Other Intervention Names

Implanon, Nexplanon, etonogestrel contraceptive implant

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

• Minimum Eligible Age: 14 Years
• Maximum Eligible Age: 24 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

University of North Carolina, Chapel Hill

OTHER

Sponsor Role: lead

Responsible Party

Amy Bryant

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

University of North Carolina Hospitals

Chapel Hill, North Carolina, United States

Countries

United States

Other Identifiers

PPI-12-0732

Identifier Type: -

Identifier Source: org_study_id