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Ultrasound use for Intrauterine Device Complication (PLUS Trial)

N/A
Waitlist Available
Led By Lisa Perriera, MD, MPH
Research Sponsored by Thomas Jefferson University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6-10 weeks
Awards & highlights

Summary

This trial will compare the rates of expulsion for women who have an IUD placed with or without ultrasound guidance following a vaginal delivery.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6-10 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6-10 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
IUD expulsion
Secondary outcome measures
IUD insertion complication
Receiving IUD

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: UltrasoundExperimental Treatment1 Intervention
For participants randomly assigned to ultrasound use, a bedside ultrasound will be performed using the trans-abdominal probe during and/or immediately after placement of the IUD. The distance from the IUD arms to the fundus will be measured with the ultrasound, and the IUD will be defined as being "in place" when the distance from the top of the IUD to the fundus is measured to be 3mm or less. If the distance is greater than 4mm, the provider may reposition the IUD manually or with a ring forceps.
Group II: No ultrasoundActive Control1 Intervention
For participants randomly assigned to no ultrasound use, provider will insert the IUD with a ring forceps and will use palpation of the fundus to determine whether or not the IUD is likely in place.

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Who is running the clinical trial?

Thomas Jefferson UniversityLead Sponsor
452 Previous Clinical Trials
148,633 Total Patients Enrolled
Lisa Perriera, MD, MPHPrincipal InvestigatorThomas Jefferson University

Media Library

Intrauterine Device Placement 2023 Treatment Timeline for Medical Study. Trial Name: NCT04474548 — N/A
~53 spots leftby Jul 2025