Does Cervical Pessary Prevent Spontaneous Preterm Birth in Twin Pregnancies With Short Cervical Length?
NCT ID: NCT02708264
Last Updated: 2018-11-16
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
NA
242 participants
INTERVENTIONAL
2016-03-01
2021-03-31
Brief Summary
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The cervical pessary is a silicone device that has been used to prevent SPTB. The efficacy of the cervical pessary has been assessed in several populations including singletons with short CL, unselected twins, twins with short CL, and triplet pregnancies. Several randomized clinical trials (RCTs) have been published, and several are ongoing. However, no consensus on use of the cervical pessary in pregnancy or guidelines for management have been assessed.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Cervical Pessary
The cervical pessary is a silicone device that has been used to prevent SPTB Pessary will be placed between 18 and 23 6/7 weeks gestation, and will be removed during the 36th week of pregnancy (or earlier if indicated)
Cervical pessary
The cervical pessary is a silicone device that has been used to prevent SPTB
No intervention
No pessary No pessary will be used. Subjects will receive standard obstetrical management
No interventions assigned to this group
Interventions
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Cervical pessary
The cervical pessary is a silicone device that has been used to prevent SPTB
Eligibility Criteria
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Inclusion Criteria
* Twin pregnancy (limits the participants to female gender)
* Short cervical length (less than or equal to 30 mm) on second trimester ultrasound at 18-23 6/7 weeks gestation
Exclusion Criteria
* Monoamniotic twins
* Twin twin transfusion syndrome
* Ruptured membranes
* Lethal fetal structural anomaly
* Fetal chromosomal abnormality
* Cerclage in place (or planned placement)
* Vaginal bleeding
* Suspicion of chorioamnionitis
* Ballooning of membranes outside the cervix into the vagina
* Painful regular uterine contractions
* Labor
* 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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214/2015
Identifier Type: -
Identifier Source: org_study_id
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