Postpartum Etonogestrel Implant for Adolescents (PPImplant)

This study is currently recruiting participants.
Verified July 2013 by University of North Carolina, Chapel Hill
Sponsor:
Information provided by (Responsible Party):
Amy Bryant, University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier:
NCT01666912
First received: August 14, 2012
Last updated: July 9, 2013
Last verified: July 2013
  Purpose

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.


Condition Intervention Phase
Adolescence
Contraception
Postpartum
Drug: Contraceptive implant
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Etonogestrel-releasing Subdermal Implant for Adolescents in the Postpartum Period: a Randomized Controlled Trial

Resource links provided by NLM:


Further study details as provided by University of North Carolina, Chapel Hill:

Primary Outcome Measures:
  • Continuation at 1 year [ Time Frame: 18 months ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Satisfaction [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    To assess satisfaction with the contraceptive implant inserted in the postpartum period.

  • Rapid repeat pregnancy [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    To assess rapid repeat pregnancies among the study population.


Estimated Enrollment: 96
Study Start Date: August 2012
Estimated Study Completion Date: February 2014
Estimated Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 6 week postpartum contraceptive implant
randomized to receive contraceptive implant at normal 6 week postpartum visit
Drug: Contraceptive implant
Other Name: 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 Name: Implanon, Nexplanon, etonogestrel contraceptive implant

  Eligibility

Ages Eligible for Study:   14 Years to 24 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01666912

Contacts
Contact: Amy G Bryant, MD, MSCR 919-843-6473 amy_bryant@med.unc.edu
Contact: Gretchen S Stuart, MD, MPHTM 919-966-7783 gstuart@med.unc.edu

Locations
United States, North Carolina
University of North Carolina Hospitals Recruiting
Chapel Hill, North Carolina, United States, 27514
Contact: Amy G Bryant, MD, MSCR    919-843-6473    amy_bryant@med.unc.edu   
Sponsors and Collaborators
University of North Carolina, Chapel Hill
  More Information

No publications provided

Responsible Party: Amy Bryant, Assistant Professor, University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier: NCT01666912     History of Changes
Other Study ID Numbers: PPI-12-0732
Study First Received: August 14, 2012
Last Updated: July 9, 2013
Health Authority: United States: Institutional Review Board
United States: Food and Drug Administration

Keywords provided by University of North Carolina, Chapel Hill:
adolescence
contraception
postpartum
rapid repeat pregnancy

Additional relevant MeSH terms:
Contraceptive Agents
3-keto-desogestrel
Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses
Contraceptive Agents, Female

ClinicalTrials.gov processed this record on April 23, 2014