Physical Exam Indicated Cerclage for Premature Births

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Albany Medical Center, Albany, NY
Premature Births+1 More
Physical Exam Indicated Cerclage - Procedure
Eligibility
18+
Female
What conditions do you have?
Select

Study Summary

RCT assessing preterm delivery rate in singleton pregnancies having a physical-exam indicated cerclage placed between 24 weeks and 25 weeks and 6 days. Patients randomized to either cerclage intervention or routine standard of care (no cerclage).

Eligible Conditions

  • Premature Births

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

1 Primary · 1 Secondary · Reporting Duration: 1 Year

1 Year
Neonatal Outcomes
Preterm Delivery Rate
1 year
Cerclage Surgical Complications

Trial Safety

Safety Progress

1 of 3

Trial Design

2 Treatment Groups

Control
1 of 2
Cerclage
1 of 2
Active Control
Experimental Treatment

30 Total Participants · 2 Treatment Groups

Primary Treatment: Physical Exam Indicated Cerclage · No Placebo Group · N/A

Cerclage
Procedure
Experimental Group · 1 Intervention: Physical Exam Indicated Cerclage · Intervention Types: Procedure
ControlNoIntervention Group · 1 Intervention: Control · Intervention Types:

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 1 year
Closest Location: Albany Medical Center · Albany, NY
Photo of new york 1Photo of new york 2Photo of new york 3
2003First Recorded Clinical Trial
2 TrialsResearching Premature Births
158 CompletedClinical Trials

Who is running the clinical trial?

Albany Medical CollegeLead Sponsor
84 Previous Clinical Trials
9,838 Total Patients Enrolled
1 Trials studying Premature Births
30 Patients Enrolled for Premature Births

Eligibility Criteria

Age 18+ · Female Participants · 5 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You are pregnant and have not had a preterm to term delivery.
You have cervical dilation between 1- 2 cm, without visible membranes beyond the external cervical os and without any evidence of infection, active labor or active bleeding between 24 0/7 and 25 6/7 weeks gestation.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.