Immediate Postplacental Insertion of IUDs at Time of Cesarean Delivery: A Randomized Clinical Trial
Information source: University of North Carolina, Chapel Hill
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Intrauterine Devices; Cesarean Section
Intervention: Immediate Postplacental Placement of an IUD during cesarean delivery (Device)
Phase: Phase 4
Status: Completed
Sponsored by: University of North Carolina, Chapel Hill Official(s) and/or principal investigator(s): Erika Levi, MD, Principal Investigator, Affiliation: University of North Carolina, Chapel Hill
Summary
This is a randomized controlled trial among women who deliver by cesarean at UNC Women's
Hospital and desire an Intrauterine Device (IUD) for contraception postpartum. After
consenting, women will be randomized to receive an IUD at time of cesarean delivery or at a
postpartum visit 4-8 weeks later. After randomization, subjects will be given a choice of
the MirenaŽ IUD or the ParagardŽ IUD. Data collection will occur at baseline, delivery, the
4-8 week postpartum visit, and 2 follow-up encounters at 3 and 6 months. We hypothesize that
women who receive an IUD at the time of cesarean will be more likely to use an IUD 6 months
later than women who plan on receiving an IUD 4-8 weeks after delivery.
Clinical Details
Official title: Immediate Postplacental Insertion of Intrauterine Devices at Time of Cesarean Delivery: A Randomized Clinical Trial
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
Primary outcome: IUD Use
Secondary outcome: IUD ExpulsionWomen's Satisfaction With IUDs
Eligibility
Minimum age: 18 Years.
Maximum age: 45 Years.
Gender(s): Female.
Criteria:
Inclusion Criteria:
- Women ages 18-45
- Pregnant and greater than or equal to 24 weeks of estimated gestational age
- Live Pregnancy
- States a plan to use an Intrauterine Device (IUD) postpartum for contraception
- Plan for cesarean delivery
- Intend to stay in the Chapel Hill area for at least 6 months after birth
- Fluent in English or Spanish
Exclusion Criteria:
- known uterine anomalies
- allergies to any component of the IUD of their choosing
- known or suspected carcinoma of the breast
- known acute liver disease or liver tumor (benign or malignant)
- known or suspected uterine or cervical neoplasia
- active pelvic inflammatory disease
- genital bleeding of unknown etiology
- history of solid organ transplantation
- positive test for gonorrhea or chlamydia during this pregnancy
Locations and Contacts
University of North Carolina, Chapel Hill, Chapel Hill, North Carolina 27514, United States
Additional Information
Starting date: March 2012
Last updated: June 16, 2015
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