TerminatedNot Applicable

Physical Exam Indicated Cerclage in Twin Gestations

Stopped: due to significant decrease of perinatal mortality in the cerclage group

United States30 participantsStarted 2015-06

Plain-language summary

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.

Who can participate

Age range18 Years – 60 Years

SexFEMALE

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Inclusion criteria

✓. 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

Exclusion criteria

✕. 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

What they're measuring

Preterm delivery less than 34 weeks

Timeframe: at delivery

Trial details

NCT IDNCT02490384

SponsorThomas Jefferson University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2019-12

View on ClinicalTrials.gov More Twin Pregnancy, Antepartum Condition or Complication trials