Clinical trial NCT03493815: A RCT of Ultrasound Guided IUD Insertion
Official title: A Randomized Controlled Trial of Ultrasound-Guided Intrauterine Device (IUD) Insertion
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: IUD Not Visible
Lead sponsor: Milton S. Hershey Medical Center
Sponsor class: OTHER
First posted: 2018-04-11
Enrollment: 85
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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

(Visit 4) At 6 months subjects will be scheduled to return to REI clinic to have an IUD string check and if no strings are visualized then this will be categorized as malposition and the investigator will continue with routine care and work up Subjects who return to clinic for Visit 4 will also have a transvaginal ultrasound performed.

If the subject does not present for a clinic follow up, then she will be contacted by the Study Coordinator or investigator via phone to see if they still have their IUD in place (and when it was removed or lost).

All subjects will be surveyed for pain with the VAS and any adverse events (including abnormal uterine bleeding) will be recorded. All subjects will be asked to categorically rate their satisfaction with the IUD on a Likert Scale.

The total duration of the study is 6 months.

Eligibility criteria: 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
* Pregnant
* Prisoners
* Cognitive Impairment
* Unable to Read or Write

Primary outcomes:
measure: Number of Participants Who Had IUD Removed Within 6 Months
timeFrame: 6 Months
Secondary outcomes:
measure: Number of Participants With Malpositioned IUD at 4-6 Week Visit
timeFrame: 4-6 Weeks Post Insertion String Check
measure: Change in Pain Score
timeFrame: pre and post-insertion (both collected during the insertion visit)
measure: Number of Participants Satisfied With IUD at 6 Months
timeFrame: 6 Months
Other outcomes:
Locations:
city: Hershey
country: United States
facility: Penn State Hershey Medical Center
state: Pennsylvania
Study officials:
affiliation: Milton S. Hershey Medical Center
name: Stephanie Estes, MD
role: PRINCIPAL_INVESTIGATOR
References: