Ultrasound-guided IUD Insertion During Family Medicine Residency Training

Not Applicable

Completed

• Conditions: IUD Insertion Complication
• Interventions: Diagnostic Test: ultrasonography

• Registration Number: NCT05594108
• Lead Sponsor: University of Saskatchewan

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-03-25
• Study Start: 2020-07-15
• Study First Submitted QC: 2022-10-24
• Study First Posted: 2022-10-26
• Primary Completion: 2024-04-01
• Study Completion: 2024-04-01
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-15
• Last Update Posted: 2024-05-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Experimental Group	ultrasonography	Ultrasound guided IUD insertion

Primary Outcome Measures

Name	Time	Method
post procedure pain score	3 years	patient pain, likert scale

Secondary Outcome Measures

Name	Time	Method
procedure completion time	3 years	time to complete IUD insertion, mins
procedure complications	3 years	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
residency confidence with procedure	3 years	family medicine resident confidence with inserting IUDs, , likert scale

Trial Locations

Locations (1)

West Winds Primary Care Center; 🇨🇦 Saskatoon, Saskatchewan, Canada