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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
PLUS Trial 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.
PLUS Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6-10 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6-10 weeks
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
PLUS 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
446 Previous Clinical Trials
147,703 Total Patients Enrolled
Lisa Perriera, MD, MPHPrincipal InvestigatorThomas Jefferson University
Media Library
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many individuals are being allowed to partake in this medical research?
"Affirmative, the clinical trials registry confirms that this medical research project is actively seeking participants. It was first published on October 5th 2020 and last updated two weeks later. A total of 254 patients are being recruited from just one site."
Answered by AI
Are there any vacancies available for individuals wishing to partake in this clinical trial?
"Affirmative. According to the clinicaltrials.gov, this research project is actively recruiting participants since its inception on October 5th 2020 and last modification of October 20th 2020. 254 individuals are required for enrollment at a single centre."
Answered by AI
Who else is applying?
What state do they live in?
New York
Pennsylvania
How old are they?
18 - 65
What site did they apply to?
Thomas Jefferson University Hospital
What portion of applicants met pre-screening criteria?
Met criteria
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