Immediate Postplacental Insertion of IUDs at Time of Cesarean Delivery: A Randomized Clinical Trial (IUD@CSD)

University of North Carolina (UNC)

Status: Completed

Conditions: Cesarean Section; Intrauterine Devices

Treatments: Device: Immediate Postplacental Placement of an IUD during cesarean delivery

Study type: Interventional

Funder types: Other

Identifiers

NCT01539759

11-2477

Details and patient eligibility

About

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.

Enrollment: 112 patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

112 participants in 2 patient groups

Interval IUD Placement

No Intervention group

Description:

Women randomized to this arm will be scheduled for their IUD placement 4-8 weeks after their cesarean delivery

Immediate Postplacental IUD placement

Experimental group

Description:

Women randomized to this arm will receive on IUD at time of cesarean delivery, immediately after the delivery of the placenta

Treatment:

Device: Immediate Postplacental Placement of an IUD during cesarean delivery