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Ultrasound-guided IUD Insertion During Family Medicine Residency Training

Sponsor
University of Saskatchewan (Other)
Overall Status
Recruiting
CT.gov ID
NCT05594108
Collaborator
(none)
40
Enrollment
1
Location
2
Arms
33.5
Anticipated Duration (Months)
1.2
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: ultrasonography
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
40 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Control group=non ultrasound guided IUD insertion Experimental group=ultrasound guided IUD insertionControl group=non ultrasound guided IUD insertion Experimental group=ultrasound guided IUD insertion
Masking:
None (Open Label)
Primary Purpose:
Other
Official Title:
Ultrasound-guided Intrauterine Device Insertion During Family Medicine Residency
Actual Study Start Date :
Jul 15, 2020
Anticipated Primary Completion Date :
May 1, 2023
Anticipated Study Completion Date :
May 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Experimental Group

Ultrasound guided IUD insertion

Diagnostic Test: ultrasonography
transabdominal ultrasonography
No Intervention: Control Group

Non ultrasound guided IUD insertion

Outcome Measures

Primary Outcome Measures

  1. post procedure pain score [3 years]

    patient pain, likert scale

Secondary Outcome Measures

  1. procedure completion time [3 years]

    time to complete IUD insertion, mins

  2. 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

  3. residency confidence with procedure [3 years]

    family medicine resident confidence with inserting IUDs, , likert scale

Eligibility Criteria

Criteria

Ages Eligible for Study:
15 Years to 50 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 West Winds Primary Care Center Saskatoon Saskatchewan Canada S7T 1C6

Sponsors and Collaborators

  • University of Saskatchewan

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Angela Baerwald, Assistant Professor, University of Saskatchewan
ClinicalTrials.gov Identifier:
NCT05594108
Other Study ID Numbers:
  • DAFM-ARB001
First Posted:
Oct 26, 2022
Last Update Posted:
Oct 26, 2022
Last Verified:
Oct 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Oct 26, 2022