Postpartum Etonogestrel Implant for Adolescents (PPImplant)

March 20, 2017 updated by: Amy Bryant, University of North Carolina, Chapel Hill

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

96

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27514
        • University of North Carolina Hospitals

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 24 years (Child, Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 6 week postpartum contraceptive implant
randomized to receive contraceptive implant at normal 6 week postpartum visit
Drug: Contraceptive implant
Other Names:
  • Implanon, Nexplanon, etonogestrel contraceptive implant
Experimental: Immediate postpartum contraceptive implant
randomized to receive contraceptive implant prior to leaving the hospital postpartum
Drug: Contraceptive implant
Other Names:
  • Implanon, Nexplanon, etonogestrel contraceptive implant

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Continuation at 1 Year
Time Frame: 12-14 months
The number of participants using the contraceptive implant at one year postpartum among women who have the implant placed immediately postpartum vs. at 6 weeks postpartum.
12-14 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Satisfaction
Time Frame: 12 months
To assess satisfaction with the contraceptive implant inserted in the postpartum period, using a scale of 0-10, with 0 being "not satisfied at all" to 10 being "extremely satisfied."
12 months
Rapid Repeat Pregnancy
Time Frame: 12 months
To assess rapid repeat pregnancies among the study population, ie, the number of participants who reported a repeat pregnancy within 12 months postpartum.
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of North Carolina, Chapel Hill

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2012

Primary Completion (Actual)

April 1, 2015

Study Completion (Actual)

April 1, 2015

Study Registration Dates

First Submitted

August 14, 2012

First Submitted That Met QC Criteria

August 14, 2012

First Posted (Estimate)

August 16, 2012

Study Record Updates

Last Update Posted (Actual)

May 1, 2017

Last Update Submitted That Met QC Criteria

March 20, 2017

Last Verified

March 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PPI-12-0732

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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