The Optimal Timing for Cerclage Removal
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Rambam Health Care Campus
- Enrollment
- 400
- Locations
- 1
- Primary Endpoint
- Cercalge removal and neonatal morbidity
Study Overview
Brief Summary
Women with a history of cervical insufficiency can be managed with elective cervical cerclage placed at the beginning of the second trimester. The McDonald technique is the most commonly used. Though lack a robust scientific evidence, the cerclage is removed electively at 36-37 weeks of gestation in order to avoid maternal cervical laceration. In addition, the incidence of spontaneous delivery is nearly 20% within 72 hours after ceclage removal, thus elective cerclage removal at 36-37 weeks may also put the newborns at complications associated with iatrogenic late preterm/early term delivery
Detailed Description
The optimal timing of cervical cerclage removal is yet unclear.
In the present study we will evaluate maternal and neonatal outcome variables after elective removal of the cerclage, and may suggest a gestational week cut-off for optimal cerclage removal/
Primary outcome:
Neonatal respiratory morbidity after cerclage removal. The respiratory outcome will be compared across each gestational week of delivery after cerclage removal, that is; group 1 (36-36.6 weeks), group 2 (37-37.6 weeks), group 3 (38-38.6 weeks), group 4 (beyond 39 weeks).
Secondary outcomes:
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Other
Eligibility Criteria
- Ages
- 18 Years to 45 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Singleton pregnancies
- •Elective or emergent cerclage in the current pregnancy
- •Cerclage that was removed after 36 weeks of pregnancy
Exclusion Criteria
- •Multiple pregnancies
- •Major congenital anomalies
- •Cerclage removal before 36weeks of pregnancy
Outcomes
Primary Outcomes
Cercalge removal and neonatal morbidity
Time Frame: 1 year
Neonatal respiratory morbidity after cerclage removal
Secondary Outcomes
- The optimal timing for cerclage removal(1 year)
Investigators
Yaniv Zipori MD
Principal Investigator
Rambam Health Care Campus