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

Cesarean Section Clinical Trial

— IUD@CSD  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01539759
• Other study ID #: 11-2477
• Status: Completed
• Phase: N/A
• First received: February 21, 2012
• Last updated: September 12, 2017
• Start date: March 2012
• Est. completion date: August 2014

Study information

• Verified date: September 2017
• Source: University of North Carolina, Chapel Hill
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 112
• Est. completion date: August 2014
• Est. primary completion date: August 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Cesarean Section
• Intrauterine Devices

Intervention

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

Locations

Country	Name	City	State
United States	University of North Carolina, Chapel Hill	Chapel Hill	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
University of North Carolina, Chapel Hill	Society of Family Planning

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	IUD Use	The use of an IUD at 6 months postpartum is the primary outcome measure	6 months postpartum
Secondary	IUD Expulsion		0-6 months postpartum
Secondary	Women's Satisfaction With IUDs		0-6 months postpartum