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OpenTrials
Completed

NCT Number: NCT05594108

Ultrasound-guided IUD Insertion During Family Medicine Residency Training

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.

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Key information

Age range

15 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

West Winds Primary Care Center

Saskatoon, Saskatchewan, S7T 1C6, Canada

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ultrasonography

Diagnostic Test

transabdominal ultrasonography

Primary outcomes

  1. post procedure pain score

    Time frame: 3 years

    patient pain, likert scale

Secondary outcomes

  1. procedure completion time

    Time frame: 3 years

    time to complete IUD insertion, mins

  2. procedure complications

    Time frame: 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

    Time frame: 3 years

    family medicine resident confidence with inserting IUDs, , likert scale

Sponsors and collaborators

Lead sponsor

University of Saskatchewan

Other

Registry information

Official study title

Ultrasound-guided Intrauterine Device Insertion During Family Medicine Residency

Important dates

Study start
2020
Primary completion
2024
Study completion
2024
First posted
Oct 26, 2022
Registry last updated
May 17, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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