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Postpartum Etonogestrel Implant for Adolescents (PPImplant)

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified July 2014 by University of North Carolina, Chapel Hill.
Recruitment status was:  Active, not recruiting
Information provided by (Responsible Party):
Amy Bryant, University of North Carolina, Chapel Hill Identifier:
First received: August 14, 2012
Last updated: July 10, 2014
Last verified: July 2014
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
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 ]
    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 ]
    To assess satisfaction with the contraceptive implant inserted in the postpartum period.

  • Rapid repeat pregnancy [ Time Frame: 12 months ]
    To assess rapid repeat pregnancies among the study population.

Estimated Enrollment: 96
Study Start Date: August 2012
Estimated Study Completion Date: April 2015
Estimated Primary Completion Date: April 2015 (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


Ages Eligible for Study:   14 Years to 24 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01666912

United States, North Carolina
University of North Carolina Hospitals
Chapel Hill, North Carolina, United States, 27514
Sponsors and Collaborators
University of North Carolina, Chapel Hill
  More Information

Responsible Party: Amy Bryant, Assistant Professor, University of North Carolina, Chapel Hill Identifier: NCT01666912     History of Changes
Other Study ID Numbers: PPI-12-0732
Study First Received: August 14, 2012
Last Updated: July 10, 2014

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

Additional relevant MeSH terms:
Contraceptive Agents
Contraceptive Agents, Female
Reproductive Control Agents
Physiological Effects of Drugs
Contraceptives, Oral, Synthetic
Contraceptives, Oral
Hormones, Hormone Substitutes, and Hormone Antagonists processed this record on April 28, 2017