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Clinical Trials/NCT05594108
NCT05594108
Completed
Not Applicable

Ultrasound-guided Intrauterine Device Insertion During Family Medicine Residency

University of Saskatchewan1 site in 1 country40 target enrollmentJuly 15, 2020

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.

Registry
clinicaltrials.gov
Start Date
July 15, 2020
End Date
April 1, 2024
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Responsible Party
Principal Investigator
Principal Investigator

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)

Study Sites (1)

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