Ultrasound-guided Intrauterine Device Insertion During Family Medicine Residency
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- IUD Insertion Complication
- Sponsor
- University of Saskatchewan
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- post procedure pain score
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
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.
Investigators
Angela Baerwald
Assistant Professor
University of Saskatchewan
Eligibility Criteria
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
Outcomes
Primary Outcomes
post procedure pain score
Time Frame: 3 years
patient pain, likert scale
Secondary Outcomes
- procedure completion time(3 years)
- procedure complications(3 years)
- residency confidence with procedure(3 years)