Postplacental Insertion of Levonorgestrel-releasing Intrauterine System (LNG-IUS) After Cesarean vs. Interval Insertion

Study Overview
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Brief Summary
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The study is a randomized controlled trial comparing outcomes of immediate postplacental insertion of the levonorgestrel-releasing intrauterine system (LNG-IUS) vs. interval insertion of the LNG-IUS performed 4-8 weeks after delivery for patients undergoing scheduled cesarean delivery. Our primary hypothesis is that the proportion of women using the LNG-IUS for contraception at 12 months after delivery will be higher in the group randomized to immediate post-placental insertion.

Official Title
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Immediate Post-placental Insertion of the Levonorgestrel-releasing Intrauterine System (LNG-IUS) After Cesarean Delivery vs. 4-8 Week Post-delivery Interval Insertion: A Randomized Controlled Trial

Conditions
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Healthy

Intervention / Treatment
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* Device: Levonorgestrel-releasing intrauterine system (LNG-IUS)
* Device: Levonorgestrel-releasing intrauterine system (LNG-IUS)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Pregnant at time of enrollment Planning to undergo a scheduled cesarean delivery Desires to use the LNG-IUS for contraception Willing and able to sign an informed consent in English Willing to comply with the study protocol Age greater than or equal to 18 years English speaking Exclusion Criteria: Allergy to either polyethylene or levonorgestrel, or other contraindications to use of the LNG-IUS Positive testing for Gonorrhea, Chlamydia, or trichomoniasis during the pregnancy without treatment and a subsequent test of cure confirming a negative result Presence of leiomyomata significantly distorting the uterine cavity and thus not allowing placement of the LNG-IUS Uterine anomaly which would not allow placement of the LNG-IUS Current cervical cancer or carcinoma in-situ Desire for repeat pregnancy in less than 12 months History of postabortal or postpartum sepsis

Ages Eligible for Study
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Minimum Age: 18 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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: postplacental insertion after cesarean<br>Immediate postplacental insertion of the LNG-IUS through the uterine incision during cesarean, within 10 minutes after delivery of the placenta Device of intervention: Levonorgestrel-releasing intrauterine system (LNG-IUS) | Device: Levonorgestrel-releasing intrauterine system (LNG-IUS)<br>* Immediate postplacental insertion of the LNG-IUS through the uterine incision during cesarean, within 10 minutes after delivery of the placenta<br>* Other names: Mirena IUD;|
| Active Comparator: delayed insertion group<br>Insertion of the LNG-IUS 4-8 weeks after cesarean delivery Device of intervention: Levonorgestrel-releasing intrauterine system (LNG-IUS) | Device: Levonorgestrel-releasing intrauterine system (LNG-IUS)<br>* Insertion of the LNG-IUS 4-8 weeks after cesarean delivery<br>* Other names: Mirena IUD;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Use of the LNG-IUS for Contraception |  | 12 months after cesarean delivery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rates of Expulsion of the LNG-IUS |  | 12 months after cesarean delivery | 
| Perforation Rates |  | 12 months after cesarean delivery | 
| Satisfaction With LNG-IUS | We measured satisfaction with the IUS at each visit using a single question with a 5 point Likert scale, with 1 being very unsatisfied, 2 unsatisfied, 3 neutral, 4 satisfied, and 5 very satisfied. For statistical purposes, subjects were determined to be SATISFIED with the IUS if they chose either 4 or 5 for this question. | 6 months after cesarean delivery | 
| Satisfaction With LNG-IUS | We measured satisfaction with the IUS at each visit using a single question with a 5 point Likert scale, with 1 being very unsatisfied, 2 unsatisfied, 3 neutral, 4 satisfied, and 5 very satisfied. For statistical purposes, subjects were determined to be SATISFIED with the IUS if they chose either 4 or 5 for this question. | 12 months after cesarean delivery | 

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