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Ultrasound-guided Intrauterine Device Insertion During Family Medicine Residency
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.
Age
15 - 50 years
Sex
FEMALE
Healthy Volunteers
Yes
West Winds Primary Care Center
Saskatoon, Saskatchewan, Canada
Start Date
July 15, 2020
Primary Completion Date
April 1, 2024
Completion Date
April 1, 2024
Last Updated
May 17, 2024
40
ACTUAL participants
ultrasonography
DIAGNOSTIC_TEST
Lead Sponsor
University of Saskatchewan
NCT05875571
NCT03828760
Data Source & Attribution
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