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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cerclage 1 | Time to delivery after cerclage removal Between 36-36.6 weeks' gestation - group 1 |
| |
| Cerclage 2 | Time to delivery after cerclage removal Between 37-37.6 weeks' gestation - group 2 |
| |
| Cerclage 3 | Between 38-38.6 weeks' gestation - group 3 |
| |
| Cerclage 4 | Time to delivery after cerclage removal Beyond 39 weeks' gestation - group 4 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cervical cerclage | Procedure | Cervical cerclage and cervical cerclage removal |
|
| Measure | Description | Time Frame |
|---|---|---|
| Cercalge removal and neonatal morbidity | Neonatal respiratory morbidity after cerclage removal | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| The optimal timing for cerclage removal | Time interval between cerclage removal and gestational age of delivery. | 1 year |
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Inclusion Criteria:
Exclusion Criteria:
Pregnant women
- Women with singleton pregnancies with elective or emergent cerclage that was electively removed after 36 weeks of pregnancy.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yaniv Zipori, M.D | Contact | +972 58 7966963 | y_zipori@rambam.health.gov.il |
| Name | Affiliation | Role |
|---|---|---|
| Yaniv Zipori, M.D | Rambam Health Care Campus | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rambam health care campus | Haifa | Israel |
Yet undecided
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| ID | Term |
|---|---|
| D023802 | Cerclage, Cervical |
| ID | Term |
|---|---|
| D013513 | Obstetric Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
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