Status:
UNKNOWN
Single Versus Double Suture Cervical Cerclage to Prevent Preterm Birth
Lead Sponsor:
Stony Brook University
Conditions:
The Primary Outcome is Preterm Delivery Before 28 Weeks Gestational Age Compared to Women With One vs Two Cerclages Placed
Eligibility:
FEMALE
18+ years
Phase:
NA
Brief Summary
Cerclage placement is known to be beneficial in prevention of preterm birth when placed inn a certain subset of patients. Clinically, the number of sutures can also vary by surgeon preference to one o...
Detailed Description
Preterm birth (PTB), defined as birth at less than 37 completed weeks is the leading cause for neonatal mortality and morbidity in the USA. The most common risk factor for PTB is a prior preterm birth...
Eligibility Criteria
Inclusion
- 18 years of age and older
- Confirmed intrauterine, live pregnancy
- Singleton gestation
- Cerclage indications including:
- Prophylactic due to history of cervical insufficiency, second trimester loss
- Ultrasound indicated short cervix \<25 mm prior to 24 weeks
Exclusion
- Rescue cerclage
- Carrying a fetus with known aneuploidy or anomaly
- Fetal demise
- Clinical intra-amniotic infection
- Rupture of membranes
- Multiple gestation
- Placental Abruption
- Technique other than McDonald
- Abdominal cerclage
Key Trial Info
Start Date :
February 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2023
Estimated Enrollment :
84 Patients enrolled
Trial Details
Trial ID
NCT04742647
Start Date
February 1 2021
End Date
July 1 2023
Last Update
October 27 2022
Active Locations (1)
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1
Stony Brook University
Stony Brook, New York, United States, 11794