Skip to main content
OpenTrials
Completed

NCT Number: NCT01666912

Postpartum Etonogestrel Implant for Adolescents

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Adolescence Contraception Postpartum

Age range

14 year–24 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

University of North Carolina Hospitals

Chapel Hill, North Carolina, 27514, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Contraceptive implant

Drug

Other names: Implanon, Nexplanon, etonogestrel contraceptive implant

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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."

  2. 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.

Sponsors and collaborators

Lead sponsor

University of North Carolina, Chapel Hill

Other

Registry information

Official study title

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

Acronym: PPImplant

Important dates

Study start
2012
Primary completion
2015
Study completion
2015
First posted
Aug 16, 2012
Registry last updated
May 1, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.