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The Optimal Timing for Cerclage Removal

The Optimal Timing for Cerclage Removal

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04151303
Enrollment
400
Registered
2019-11-05
Start date
2019-12-01
Completion date
2021-01-01
Last updated
2019-11-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Respiratory Disease of A Newborn

Keywords

RDS, CERCLAGE, CERVIX INSUFFICIENCY

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: Time interval between cerclage removal and gestational age of delivery.

Interventions

Cervical cerclage and cervical cerclage removal

Sponsors

Rambam Health Care Campus
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
OTHER

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 45 Years
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

Design outcomes

Primary

MeasureTime frameDescription
Cercalge removal and neonatal morbidity1 yearNeonatal respiratory morbidity after cerclage removal

Secondary

MeasureTime frameDescription
The optimal timing for cerclage removal1 yearTime interval between cerclage removal and gestational age of delivery.

Countries

Israel

Contacts

Primary ContactYaniv Zipori, M.D
y_zipori@rambam.health.gov.il+972 58 7966963

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026