Copper Intrauterine Device (IUD) Insertion at Cesarean Delivery

Study Overview
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Brief Summary
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The purpose of this study is to determine the expulsion rates of copper Intrauterine Devices (IUDs) placed at time of Cesarean Delivery.

Detailed Description
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This was a prospective clinical study with 90 patients undergoing cesarean section. After delivery of the placenta, a ParaGard® copper T380A IUD was inserted through the hysterotomy site. IUD placement was confirmed by visualization of the strings at the cervical os or via ultrasound at the 6 week postpartum visit. Subjects also received a phone call 6 months after IUD placement to ascertain physician follow-up and patient satisfaction. This telephone call was to ensure that each subject attended her postpartum visit, had an evaluation of IUD placement and then we performed a survey. This survey used a Likert Scale to measure each subject's satisfaction. The fields included very satisfied, satisfied, somewhat satisfied, neutral, somewhat unsatisfied, unsatisfied and very unsatisfied.

Official Title
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Transcesarean IUD Insertion: A Prospective Cohort Study

Conditions
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Intrauterine Device Expulsion

Intervention / Treatment
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* Device: Copper IUD placement at time Cesarean Delivery (Copper T 380A)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: singleton gestation greater than 35 weeks gestation speaks English or Spanish desires IUD for contraception undergoing a cesarean delivery Exclusion Criteria: evidence of chorioamnionitis history of chlamydia within this pregnancy

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Copper IUD placement at time Cesarean Delivery (Copper T 380A)|Placement of Paragard IUD at time of Cesarean Delivery|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Expulsion of IUD | Number of participants with Expulsion of IUDs placed at time of cesarean delivery. | 6 week postpartum | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Satisfaction of IUD Placement | Satisfaction of subjects who received an IUD at time of cesarean delivery was measured based on a telephone survey administered 6 months postpartum. A 4-point Likert scale (Very Happy/Happy, Somewhat Happy, Unsure, Unhappy) was used to evaluate participants' attitude toward the IUD. | 6 months postpartum | 
| Number of Participants With Expulsion of IUD | Number of participants with Expulsion of IUDs placed at time of cesarean delivery. | 6 months postpartum | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Postpartum IUD, Cesarean Delivery, 6 months postpartum, satisfaction