Cerclage for Twins With Short Cervical Length ≤ 15mm
Status unconfirmed · Not applicable
Conditions studied: Twin Pregnancy With Antenatal Problem, Preterm Birth, Short Cervix
In brief
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 and cervical length ≤15mm, diagnosed by transvaginal ultrasound between 16 to 23 6/7 weeks of gestation.
Key facts
- Study ID
- NCT03340688
- Run by
- Thomas Jefferson University
- People needed
- 200
- Starts
- 2017-06-22
- Expected to finish
- 2025-06-01
- Last updated by the study team
- 2020-04-27
Who can join
Age: 18 and older, up to 60. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- University of Barcelona — Barcelona, Spain (enrolling)
- Thomas Jefferson University Hospital — Philadelphia, Pennsylvania, United States (enrolling)
- Austin Maternal Fetal Medicine St David's Health Care — Austin, Texas, United States (enrolling)
- The Egyptian IVF Center — Cairo, Egypt (enrolling)
- Bologna University — Bologna, Italy (enrolling)
- University of Brescia — Brescia, Italy (enrolling)
- Università degli Studi di Napoli "Federico II" — Naples, Italy (enrolling)
- George Washington University — Washington D.C., District of Columbia, United States
Full record on ClinicalTrials.gov
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