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Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up approximately 12 minutes
Awards & highlights
Study Summary
This trial is testing whether a Foley balloon is as effective as osmotic dilators for preparing the cervix before a second trimester abortion. The time it takes to do the procedure will be compared to see which is easier for the surgeon.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ approximately 12 minutes
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~approximately 12 minutes
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Procedure time
Secondary outcome measures
Cervical dilation
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Foley balloonExperimental Treatment1 Intervention
A Foley balloon will be inserted for cervical preparation and filled to 30mL of water or saline. The balloon will stay in until the next day prior to their procedure, or earlier if it falls out on its own.
Group II: Dilapan-SPlacebo Group1 Intervention
A number of Dilapan-S will be inserted for cervical preparation. The number will be determined by a standard protocol that is based on gestational age. The dilators will stay in until the next day prior to their procedure, or earlier if they fall out on their own.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Single Foley Balloon
2022
N/A
~40
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Who is running the clinical trial?
Stanford UniversityLead Sponsor
2,386 Previous Clinical Trials
17,333,976 Total Patients Enrolled
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are individuals currently enrolling in this research endeavor?
"According to current information on clinicaltrials.gov, this investigation is not enrolling any new individuals at present. The trial was first published on February 8th 2022 and had its latest update posted 5/5/2022; however, there are other research initiatives actively looking for volunteers right now."
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