A Randomized Controlled Trial of Ultrasound-Guided Intrauterine Device (IUD) Insertion
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 85
- Locations
- 1
- Primary Endpoint
- Number of Participants Who Had IUD Removed Within 6 Months
Study Overview
Brief Summary
To determine the utility of ultrasound guided IUD insertion compared to the traditional blind insertion at an academic health institute where the skill level of the provider can vary greatly. We hypothesize that ultrasound-guided insertion will lead lower IUD discontinuation rates and greater patient satisfaction.
Detailed Description
(Visit 1) All interested women undergoing a scheduled IUD insertion will be screened for inclusion/exclusion criteria by the study coordinator or investigator prior to their clinic visit.
(Visit 2) After meeting eligibility criteria and being consented for the study, a subject will be ready to be randomized. Subject in both groups will fill out a visual analogue score (VAS) before and after the procedure grading their pain. Subjects will be instructed to call the investigator if they experience any abnormal uterine bleeding or problems with their IUD.
Subjects will then be randomized to one of two groups:
Group A: traditional blind IUD insertion. Group B: transabdominal ultrasound guided IUD insertion. Subjects will be randomized to either US guided or traditional placement of IUD using 1:1 allocation. The randomization scheme for this study will use variable-size, random permuted blocks where the variable block sizes are 2,4 and 6.
(Visit 3) Subjects will be scheduled to return to REI clinic 4-6 weeks (Visit 2) after insertion of the IUD as routine follow-up. Subjects will be asked about any adverse events. A routine string check in the form of a speculum exam will be performed in addition to a transvaginal ultrasound to confirm positioning of the IUD. If malposition is determined, then routine care will be to remove the IUD. The ultrasound operator will be blinded to the subject's arm in the study
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Undergoing IUD Insertion in an Office Setting
- •Fluent in Spoken and Written English
- •Premenopausal
Exclusion Criteria
- •Less than 6 Weeks Postpartum at Time of IUD Insertion
- •Intraoperative IUD Insertion
- •Prisoners
- •Cognitive Impairment
- •Unable to Read or Write
Arms & Interventions
Transabdominal Ultrasound Guided IUD Insertion
Ultrasound Guided IUD Insertion: Comparing the utility of ultrasound-guided intrauterine device (IUD) insertion compared to traditional blind insertion
Intervention: Transabdominal Ultrasound Guided IUD Insertion (Procedure)
Traditional Blind IUD Insertion
Traditional blind IUD insertion: Comparing the utility of ultrasound-guided intrauterine device (IUD) insertion compared to traditional blind insertion
Intervention: Traditional Blind IUD Insertion (Procedure)
Outcomes
Primary Outcomes
Number of Participants Who Had IUD Removed Within 6 Months
Time Frame: 6 Months
IUD discontinuation rates during the 6-month post-insertion period
Secondary Outcomes
- Number of Participants With Malpositioned IUD at 4-6 Week Visit(4-6 Weeks Post Insertion String Check)
- Change in Pain Score(pre and post-insertion (both collected during the insertion visit))
- Number of Participants Satisfied With IUD at 6 Months(6 Months)
Investigators
Stephanie Estes
Assistant Professor, Director, Robotic Surgical Services
Milton S. Hershey Medical Center