Ultrasound-guided IUD Insertion During Family Medicine Residency Training

NCT05594108 | Completed

• 1 other identifier: DAFM-ARB001
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• post procedure pain score

  patient pain, likert scale

  3 years

Secondary Outcomes (3)

• procedure completion time

  3 years

• procedure complications

  3 years

• residency confidence with procedure

  3 years

Study Arms (2)

Experimental Group

EXPERIMENTAL

Ultrasound guided IUD insertion

Diagnostic Test: ultrasonography

Control Group

NO INTERVENTION

Non ultrasound guided IUD insertion

Interventions

ultrasonography DIAGNOSTIC_TEST

transabdominal ultrasonography

Experimental Group

Eligibility Criteria

• Age: 15 Years - 50 Years
• Gender Eligibility Details: Individuals that identify as a female gender will be eligible to participate
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• pregnancy, \< 6 weeks postpartum

Sponsors & Collaborators

• University of Saskatchewan: lead

Study Sites (1)

West Winds Primary Care Center

Saskatoon, Saskatchewan, S7T 1C6, Canada

Location

MeSH Terms

Interventions

Ultrasonography

Intervention Hierarchy (Ancestors)

Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Control group=non ultrasound guided IUD insertion Experimental group=ultrasound guided IUD insertion

Study Record Dates

• First Submitted: March 25, 2020
• First Posted: October 26, 2022
• Study Start: July 15, 2020
• Primary Completion: April 1, 2024
• Study Completion: April 1, 2024
• Last Updated: May 17, 2024

Record last verified: 2024-05

Locations

CA (1)