Ultrasound-guided IUD Insertion During Family Medicine Residency Training

IUD Insertion Complication Clinical Trial

Official title:

Ultrasound-guided Intrauterine Device Insertion During Family Medicine Residency

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05594108
• Other study ID #: DAFM-ARB001
• Status: Completed
• Phase: N/A
• Start date: July 15, 2020
• Est. completion date: April 1, 2024

Study information

• Verified date: May 2024
• Source: University of Saskatchewan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: April 1, 2024
• Est. primary completion date: April 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 15 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• IUD Insertion Complication

Intervention

Diagnostic Test:
• ultrasonography
transabdominal ultrasonography

Locations

Country	Name	City	State
Canada	West Winds Primary Care Center	Saskatoon	Saskatchewan

Sponsors (1)

Lead Sponsor	Collaborator
University of Saskatchewan

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	post procedure pain score	patient pain, likert scale	3 years
Secondary	procedure completion time	time to complete IUD insertion, mins	3 years
Secondary	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
Secondary	residency confidence with procedure	family medicine resident confidence with inserting IUDs, , likert scale	3 years