Ultrasound-guided IUD Insertion During Family Medicine Residency Training

NCT ID: NCT05594108

Last Updated: 2024-05-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-07-15
• Study Completion Date: 2024-04-01

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.

Conditions

IUD Insertion Complication

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Experimental Group

Ultrasound guided IUD insertion

Group Type: EXPERIMENTAL

ultrasonography

Intervention Type: DIAGNOSTIC_TEST

transabdominal ultrasonography

Control Group

Non ultrasound guided IUD insertion

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

ultrasonography

transabdominal ultrasonography

Intervention Type: DIAGNOSTIC_TEST

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

• Minimum Eligible Age: 15 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

University of Saskatchewan

OTHER

Sponsor Role: lead

Responsible Party

Angela Baerwald

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

West Winds Primary Care Center

Saskatoon, Saskatchewan, Canada

Countries

Canada

Other Identifiers

DAFM-ARB001

Identifier Type: -

Identifier Source: org_study_id