Ultrasound-guided IUD Insertion During Family Medicine Residency Training

Study Overview
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Brief Summary
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The objective of this pilot study is to test that hypothesis that ultrasound guided IUD placement by family medicine residents improves patient pain scores, procedure completion time, and procedure complication rates. The secondary objective is to test the hypothesis that ultrasound guided IUD placement improves resident confidence in performing the procedure. A prospective, randomized controlled pilot study will be conducted in the Department of Academic Family Medicine at the University of Saskatchewan. All women undergoing IUD placement (hormonal or non-hormonal) at West Winds Primary Care Center from Mar 1, 2020- Mar 1, 2021 will be invited to participate. Informed consent will be obtained from each patient and the resident inserting the IUD prior to initiating study procedures. The control group will comprise 20 women undergoing non-ultrasound guided IUD placement. The experimental group will comprise 20 women undergoing transabdominal ultrasound guided IUD placement. Patient pain scores and resident confidence scores will be tabulated using likert scales and compared between control and experimental groups using independent sample t-tests. Procedure completion time (minutes) will be compared between groups using t-tests. Procedure complications rates will be categorized as: a) inability to penetrate the cervix, b) improper location, c) inability to release the IUD from the insertion device, d) perforation, e) vasovagal reactions, and f) post-procedure infection; outcomes will be compared between groups using Chi-square analyses.

Official Title
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Ultrasound-guided Intrauterine Device Insertion During Family Medicine Residency

Conditions
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IUD Insertion Complication

Intervention / Treatment
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* Diagnostic Test: ultrasonography


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: all women of pre or perimenopausal age undergoing IUD (hormonal or non-hormonal) placement at West Winds Primary Care Center from Mar1, 2020 to Mar1, 2021 Exclusion Criteria: pregnancy, < 6 weeks postpartum

Ages Eligible for Study
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Minimum Age: 15 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: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Control group=non ultrasound guided IUD insertion Experimental group=ultrasound guided IUD insertion
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental Group<br>Ultrasound guided IUD insertion | Diagnostic Test: ultrasonography<br>* transabdominal ultrasonography<br>|
| No Intervention: Control Group<br>Non ultrasound guided IUD insertion | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| post procedure pain score | patient pain, likert scale | 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| procedure completion time | time to complete IUD insertion, mins | 3 years | 
| procedure complications | a) inability to penetrate the cervix, b) improper location, c) inability to release the IUD from the insertion device, d) perforation, e) vasovagal reactions, and f) post-procedure infection | 3 years | 
| residency confidence with procedure | family medicine resident confidence with inserting IUDs, , likert scale | 3 years |