A RCT of Ultrasound Guided IUD Insertion

NCT ID: NCT03493815

Last Updated: 2020-05-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 85 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-03-08
• Study Completion Date: 2019-04-30

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.

Conditions

IUD Not Visible

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Transabdominal Ultrasound Guided IUD Insertion

Ultrasound Guided IUD Insertion: Comparing the utility of ultrasound-guided intrauterine device (IUD) insertion compared to traditional blind insertion

Group Type: EXPERIMENTAL

Transabdominal Ultrasound Guided IUD Insertion

Intervention Type: PROCEDURE

Comparing the utility of ultrasound-guided intrauterine device (IUD) insertion compared to traditional blind insertion

Traditional Blind IUD Insertion

Traditional blind IUD insertion: Comparing the utility of ultrasound-guided intrauterine device (IUD) insertion compared to traditional blind insertion

Group Type: ACTIVE_COMPARATOR

Traditional Blind IUD Insertion

Intervention Type: PROCEDURE

Comparing the utility of ultrasound-guided intrauterine device (IUD) insertion compared to traditional blind insertion

Interventions

Transabdominal Ultrasound Guided IUD Insertion

Comparing the utility of ultrasound-guided intrauterine device (IUD) insertion compared to traditional blind insertion

Intervention Type: PROCEDURE

Traditional Blind IUD Insertion

Comparing the utility of ultrasound-guided intrauterine device (IUD) insertion compared to traditional blind insertion

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Milton S. Hershey Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Stephanie Estes

Assistant Professor, Director, Robotic Surgical Services

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Stephanie Estes, MD

Role: PRINCIPAL_INVESTIGATOR

Milton S. Hershey Medical Center

Locations

Penn State Hershey Medical Center

Hershey, Pennsylvania, United States

Countries

United States

Provided Documents

Document Type: Study Protocol, Statistical Analysis Plan, and Informed Consent Form

View Document

Other Identifiers

STUDY00008432

Identifier Type: -

Identifier Source: org_study_id