Physical Exam Indicated Cerclage in Twin Gestations

Stopped early · Not applicable

Conditions studied: Twin Pregnancy, Antepartum Condition or Complication, Preterm Birth, Cervical Dilation Premature

In brief

This is a multicenter randomized study designed to determine if physical exam indicated cerclage reduces the incidence of spontaneous preterm birth \<34 weeks in asymptomatic women with twin gestations and dilated cervix, diagnosed by pelvic exam between 16 to 23 6/7 weeks of gestation.

Key facts

Study ID

NCT02490384

Run by

Thomas Jefferson University

People needed

30

Starts

2015-06-01

Expected to finish

2019-12-12

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 older than 18 years of age
• Diamniotic twin pregnancy
• Cervical dilation between 1 to 5 cm and/or visible membranes by pelvic exam or speculum exam between at 16-23 6/7 weeks gestation

You may not qualify if…

• Singleton pregnancy or higher order than twins multiple gestation
• Cervical dilation more than 5 cm
• Amniotic membranes prolapsed beyond external os into the vagina, unable to visualize cervical tissue
• More than 24 weeks of gestation
• Multifetal reduction after 14 weeks
• Monoamniotic twins
• Twin-twin transfusion syndrome
• Ruptured amniotic membranes at the time of diagnosis of dilated cervix
• Major fetal structural anomaly
• Fetal chromosomal abnormality
• Cerclage already in place for other indications
• Active vaginal bleeding
• Suspicion of clinical or biochemical chorioamnionitis
• Painful regular uterine contractions
• Labor (progressing cervical dilation)
• Placenta previa

Where it is running

• George Washington University — Washington D.C., District of Columbia, United States
• Albany Medical Center — Albany, New York, United States
• Columbia University Medical Center — New York, New York, United States
• University of Rochester Medical Center — Rochester, New York, United States
• Wright State University — Dayton, Ohio, United States
• Thomas Jefferson University Hospital — Philadelphia, Pennsylvania, United States
• Austin Maternal Fetal Medicine St David's Health Care — Austin, Texas, United States
• Bologna University — Bologna, Italy
• University of Brescia — Brescia, Italy
• Università degli Studi di Napoli "Federico II" — Naples, Italy
• University of Warsaw — Warsaw, Poland

Full record on ClinicalTrials.gov

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