The Optimal Timing for Cerclage Removal

Study Overview
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Brief Summary
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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
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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.

Official Title
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The Optimal Timing for Cerclage Removal

Conditions
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Respiratory Disease of A Newborn

Intervention / Treatment
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* Procedure: Cervical cerclage


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Cerclage 1<br>Time to delivery after cerclage removal Between 36-36.6 weeks' gestation - group 1 | Procedure: Cervical cerclage<br>* Cervical cerclage and cervical cerclage removal<br>|
| Cerclage 2<br>Time to delivery after cerclage removal Between 37-37.6 weeks' gestation - group 2 | Procedure: Cervical cerclage<br>* Cervical cerclage and cervical cerclage removal<br>|
| Cerclage 3<br>Between 38-38.6 weeks' gestation - group 3 | Procedure: Cervical cerclage<br>* Cervical cerclage and cervical cerclage removal<br>|
| Cerclage 4<br>Time to delivery after cerclage removal Beyond 39 weeks' gestation - group 4 | Procedure: Cervical cerclage<br>* Cervical cerclage and cervical cerclage removal<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cercalge removal and neonatal morbidity | Neonatal respiratory morbidity after cerclage removal | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The optimal timing for cerclage removal | Time interval between cerclage removal and gestational age of delivery. | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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RDS, CERCLAGE, CERVIX INSUFFICIENCY