Immediate Postplacental Insertion of IUDs at Time of Cesarean Delivery: A Randomized Clinical Trial

Not Applicable

Completed

• Conditions: Intrauterine Devices; Cesarean Section
• Interventions: Device: Immediate Postplacental Placement of an IUD during cesarean delivery

• Registration Number: NCT01539759
• Lead Sponsor: University of North Carolina, Chapel Hill

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-02-21
• Study First Submitted QC: 2012-02-21
• Study First Posted: 2012-02-27
• Study Start: 2012-03
• Primary Completion: 2014-08
• Study Completion: 2014-08
• Results First Submitted: 2015-06-16
• Results First Submitted QC: 2015-06-16
• Results First Posted: 2015-07-09
• Status Verified: 2017-09
• Last Update Submitted: 2017-09-12
• Last Update Posted: 2017-10-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 112

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

Read More

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Immediate Postplacental IUD placement	Immediate Postplacental Placement of an IUD during cesarean delivery	Women randomized to this arm will receive on IUD at time of cesarean delivery, immediately after the delivery of the placenta

Primary Outcome Measures

Name	Time	Method
IUD Use	6 months postpartum	The use of an IUD at 6 months postpartum is the primary outcome measure

Secondary Outcome Measures

Name	Time	Method
Women's Satisfaction With IUDs	0-6 months postpartum
IUD Expulsion	0-6 months postpartum

Trial Locations

Locations (1)

University of North Carolina, Chapel Hill; 🇺🇸 Chapel Hill, North Carolina, United States