Overview

This trial is active, not recruiting.

Conditions intrauterine devices, cesarean section
Treatment immediate postplacental placement of an iud during cesarean delivery
Phase phase 4
Sponsor University of North Carolina, Chapel Hill
Collaborator Society of Family Planning
Start date February 2012
End date June 2014
Trial size 112 participants
Trial identifier NCT01539759, 11-2477

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 Mirena® IUD or the Paragard® 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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose prevention
Arm
(No Intervention)
Women randomized to this arm will be scheduled for their IUD placement 4-8 weeks after their cesarean delivery
(Experimental)
Women randomized to this arm will receive on IUD at time of cesarean delivery, immediately after the delivery of the placenta
immediate postplacental placement of an iud during cesarean delivery
Women randomized to this arm will have an IUD placed during their cesarean delivery, immediately after delivery of the placenta

Primary Outcomes

Measure
IUD use
time frame: 6 months postpartum

Secondary Outcomes

Measure
IUD Expulsion
time frame: 0-6 months postpartum
Women's satisfaction with IUDs
time frame: 0-6 months postpartum

Eligibility Criteria

Female participants from 18 years up to 45 years old.

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

Additional Information

Official title Immediate Postplacental Insertion of Intrauterine Devices at Time of Cesarean Delivery: A Randomized Clinical Trial
Principal investigator Erika Levi, MD
Trial information was received from ClinicalTrials.gov and was last updated in February 2014.
Information provided to ClinicalTrials.gov by University of North Carolina, Chapel Hill.