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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 Expulsion

Women'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

Page last updated: August 23, 2015

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