IUD Insertion Complication
Conditions
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.
Interventions
DIAGNOSTIC_TESTultrasonography
transabdominal ultrasonography
Sponsors
University of Saskatchewan
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Intervention model description
Control group=non ultrasound guided IUD insertion Experimental group=ultrasound guided IUD insertion
Eligibility
Sex/Gender
FEMALE
Age
15 Years to 50 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| post procedure pain score | 3 years | patient pain, likert scale |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| procedure completion time | 3 years | time to complete IUD insertion, mins |
| 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 |
| residency confidence with procedure | 3 years | family medicine resident confidence with inserting IUDs, , likert scale |
Countries
Canada
Outcome results
None listed