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NCT05594108

Ultrasound-guided IUD Insertion During Family Medicine Residency Training

Completed NA Last updated 17 May 2024
What this trial tests

NA trial testing ultrasonography in IUD Insertion Complication in 40 participants. Completed in 1 April 2024.

Timeline
15 July 2020
Primary endpoint
1 April 2024
1 April 2024

Quick facts

Lead sponsorUniversity of Saskatchewan
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingnone
Primary purposeother
Enrollment40
Start date15 July 2020
Primary completion1 April 2024
Estimated completion1 April 2024
Sites1 location across Canada

Drugs / interventions tested

Conditions studied

Sponsor

University of Saskatchewan

Who can join

Adults 15 to 50, female only, with IUD Insertion Complication. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

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Other trials of ultrasonography

Trials testing the same drug.

Other University of Saskatchewan trials

Trials by the same sponsor.

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Data sources for this page

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