NCT01539759

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 112 (actual)
• Sponsor: University of North Carolina, Chapel Hill · Academic / Other
• Sex: Female
• Age: 18 Years – 45 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Intrauterine Devices
• Cesarean Section

Interventions

Type	Name	Description
DEVICE	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

Timeline

• Start date: 2012-03-01
• Primary completion: 2014-08-01
• Completion: 2014-08-01
• First posted: 2012-02-27
• Last updated: 2017-10-13
• Results posted: 2015-07-09

Locations

1 site across 1 country: United States