Simplified IUD Insertion Technique

Study Overview
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Brief Summary
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This is a randomized controlled trial that compares traditional IUD insertion with that of a no uterine sound, no bimanual pelvic exam approach. The investigators hypothesis is that IUD placement is safe and effective without pre-procedural assessment of uterine size, direction, or depth.

Official Title
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Simplified IUD Insertion Technique: A Randomized Controlled Trial

Conditions
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Contraception

Intervention / Treatment
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* Procedure: Simplified IUD Insertion


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Women 18 years and older presenting to contraceptive clinic in Gaborone, Botswana for IUD insertion and have ability to give informed consent. Exclusion Criteria: Known contradictions to copper IUD, inability to comply with study protocol

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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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: Arm 1: Traditional IUD Insertion<br>Standard IUD insertion according to package insert. Bimanual pelvic exam to assess uterine size and position will be performed. Uterine sound will be used to measure depth of uterus prior to insertion. | |
| Experimental: Arm 2: Simplified IUD Insertion<br>Simplified, investigational IUD insertion performed. No bimanual pelvic exam or uterine sounding. | Procedure: Simplified IUD Insertion<br>* IUD Insertion with no bimanual pelvic exam or uterine sounding.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correct IUD Placement Immediately Post-Insertion | Percent of correct IUD placements between control (traditional IUD insertion) and experimental (simplified IUD insertion) groups at time of insertion as visualized by transvaginal ultrasound. | Immediately post-insertion | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correct IUD Placements 4-6 Weeks Post-Insertion | Percent of correct IUD placements between control (traditional IUD insertion) and experimental (simplified IUD insertion) groups at 4-6 weeks after insertion as visualized by transvaginal ultrasound. | 4-6 weeks post-insertion | 
| Patient Satisfaction with IUD Insertion | Visual Analogue Scale (VAS) | Immediately Post-Insertion | 
| Patient Pain Scores (VAS) | Visual Analogue Scale (VAS) | Immediately Post-Insertion | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Long Acting Reversible Contraception, Intrauterine Device (IUD), Intrauterine Device (IUD) Insertion, Family Planning, International Family Planning