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

Study Overview
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Brief Summary
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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.

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

Conditions
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Intrauterine Devices, Cesarean Section

Intervention / Treatment
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* Device: Immediate Postplacental Placement of an IUD during cesarean delivery


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Interval IUD Placement<br>Women randomized to this arm will be scheduled for their IUD placement 4-8 weeks after their cesarean delivery | |
| Experimental: Immediate Postplacental IUD placement<br>Women randomized to this arm will receive on IUD at time of cesarean delivery, immediately after the delivery of the placenta | Device: Immediate Postplacental Placement of an IUD during cesarean delivery<br>* Women randomized to this arm will have an IUD placed during their cesarean delivery, immediately after delivery of the placenta<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| IUD Use | The use of an IUD at 6 months postpartum is the primary outcome measure | 6 months postpartum | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| IUD Expulsion |  | 0-6 months postpartum | 
| Women's Satisfaction With IUDs |  | 0-6 months postpartum | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Postpartum Contraception, Intrauterine Devices