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Procedure
Double cerclage for Preterm Delivery
N/A
Recruiting
Research Sponsored by Stony Brook University
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 through study completion, an average of 1 year
Awards & highlights
Study Summary
This trial looks at whether placing two stitches instead of one in a cerclage procedure (a surgery to help prevent preterm birth) is more effective. Retrospective data (data from past cases) suggests that two stitches may be more effective, but this has not been proven in a large, controlled trial yet. The authors propose conducting a randomized control trial (a type of experiment where some patients receive the standard treatment and some receive the experimental treatment, and the outcomes are compared) to answer this question.
Eligible Conditions
- Preterm Delivery Before 28 Weeks Gestational Age Compared to Women With One vs Two Cerclages Placed
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ through study completion, an average of 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion, an average of 1 year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Preterm delivery <28 weeks gestation
Secondary outcome measures
Preterm delivery <34 weeks gestation
Preterm delivery <37 weeks gestation
Trial Design
2Treatment groups
Experimental Treatment
Group I: Single CerclageExperimental Treatment1 Intervention
Standard single cervical cerclage will be placed
Group II: Double CerclageExperimental Treatment1 Intervention
Double cerclage placement
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Who is running the clinical trial?
Stony Brook UniversityLead Sponsor
217 Previous Clinical Trials
39,902 Total Patients Enrolled
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