Status:
UNKNOWN
Cerclage for Twins With Short Cervical Length ≤ 15mm
Lead Sponsor:
Thomas Jefferson University
Collaborating Sponsors:
Federico II University
Conditions:
Twin Pregnancy With Antenatal Problem
Preterm Birth
Eligibility:
FEMALE
18-60 years
Phase:
NA
Brief Summary
This is a multicenter randomized study designed to determine if ultrasound indicated cerclage reduces the incidence of spontaneous preterm birth \<34 weeks in asymptomatic women with twin gestations a...
Detailed Description
Twin pregnancies have 59% incidence of preterm delivery (before 37 weeks of gestation), with increased perinatal mortality and neonatal morbidity. No therapy has proven effective in preventing preterm...
Eligibility Criteria
Inclusion
- Pregnant women more than 18 years of age (limits the participants to female gender)
- Diamniotic twin pregnancy
- Asymptomatic
- Transvaginal cervical length ≤ 15 mm between 16-23 6/7 weeks gestation
Exclusion
- Singleton or higher order than twins multiple gestation
- Transvaginal cervical length \>15mm
- Cervical dilation with visible amniotic membranes
- Amniotic membranes prolapsed into the vagina
- Fetal reduction after 14 weeks form higher order
- Monoamniotic twins
- Twin-twin transfusion syndrome
- Ruptured membranes
- Major fetal structural anomaly
- Fetal chromosomal abnormality
- Cerclage already in place for other indication
- Active vaginal bleeding
- Clinical chorioamnionitis
- Placenta previa
- Painful regular uterine contractions
- Labor
Key Trial Info
Start Date :
June 22 2017
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2025
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT03340688
Start Date
June 22 2017
End Date
June 1 2025
Last Update
April 27 2020
Active Locations (8)
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1
George Washington University
Washington D.C., District of Columbia, United States, 20052
2
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, United States, 19107
3
Austin Maternal Fetal Medicine St David's Health Care
Austin, Texas, United States, 78758
4
The Egyptian IVF Center
Cairo, Egypt