Postpartum Etonogestrel Implant for Adolescents

Contraception Clinical Trial

— PPImplant  

Official title:

Etonogestrel-releasing Subdermal Implant for Adolescents in the Postpartum Period: a Randomized Controlled Trial

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01666912
• Other study ID #: PPI-12-0732
• Status: Active, not recruiting
• Phase: Phase 4
• First received: August 14, 2012
• Last updated: July 10, 2014
• Start date: August 2012
• Est. completion date: April 2015

Study information

• Verified date: July 2014
• Source: University of North Carolina, Chapel Hill
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review BoardUnited States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 96
• Est. completion date: April 2015
• Est. primary completion date: April 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 14 Years to 24 Years

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Adolescence
• Contraception
• Postpartum

Intervention

Drug:
• Contraceptive implant

Locations

Country	Name	City	State
United States	University of North Carolina Hospitals	Chapel Hill	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
University of North Carolina, Chapel Hill

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Continuation at 1 year	To compare the use of the contraceptive implant at one year postpartum among women who have the implant placed immediately postpartum vs. at 6 weeks postpartum.	18 months	No
Secondary	Satisfaction	To assess satisfaction with the contraceptive implant inserted in the postpartum period.	12 months	No
Secondary	Rapid repeat pregnancy	To assess rapid repeat pregnancies among the study population.	12 months	No