Cerclage for Singletons With Short Cervix Without Prior Preterm Birth
NCT ID: NCT02716922
Last Updated: 2016-03-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
300 participants
INTERVENTIONAL
2016-03-31
2019-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Cervical cerclage
Women randomized to receive cerclage should receive cervical cerclage Cerclage is a circumferential stitch of non-absorbable suture placed around the cervix
Cervical cerclage
Cerclage is a circumferential stitch of non-absorbable suture placed around the cervix Cerclage type: McDonald Cerclage Suture: Permanent monofilament Pericerclage antibiotics: none Pericerclage tocolytics: none Bed rest: not recommended (in both groups)
No intervention
No cerclage Women randomized to not receive cerclage represent the control arm
No interventions assigned to this group
Interventions
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Cervical cerclage
Cerclage is a circumferential stitch of non-absorbable suture placed around the cervix Cerclage type: McDonald Cerclage Suture: Permanent monofilament Pericerclage antibiotics: none Pericerclage tocolytics: none Bed rest: not recommended (in both groups)
Eligibility Criteria
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Inclusion Criteria
* Short cervical length (less than or equal to 25 mm) on second trimester ultrasound at 18-23 6/7 weeks gestation
* 18-50 years of age
Exclusion Criteria
* Prior spontaneous preterm birth 16-36 6/7 weeks
* Ruptured membranes
* Lethal fetal structural anomaly
* Fetal chromosomal abnormality
* Pessary in place (or planned placement)
* Vaginal bleeding
* Suspicion of chorioamnionitis
* Ballooning of membranes outside the cervix into the vagina or CL = 0 mm on transvaginal ultrasound
* Painful regular uterine contractions
* Placenta previa
18 Years
50 Years
FEMALE
No
Sponsors
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Federico II University
OTHER
Responsible Party
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Gabriele Saccone
Medical Doctor
Locations
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Gabriele Saccone
Napoli, , Italy
Countries
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Facility Contacts
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Other Identifiers
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33/2016
Identifier Type: -
Identifier Source: org_study_id
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