Physical Exam Indicated Cerclage in Twin Gestations (TWIN-PEIC)

Columbia University, Federico II University, Albany Medical College, University of Rochester, George Washington University, Wright State University, Baystate Medical Center, Università degli Studi di Brescia, University of Bologna, University Hospital, Geneva, University of Warsaw, Maternal Fetal Medicine Associates

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.

Twin pregnancies have 58% incidence of preterm delivery (before 37 weeks of gestation), with increased perinatal mortality and neonatal morbidity. No therapy has proven effective in preventing preterm birth in twins. When cervical dilation is identified before 24 weeks in singleton pregnancies, the risk of preterm birth is 90%-100%; based on a small series of cases, approximately 50% of twin gestations with cervical dilation will be delivered prior to viability (24 weeks) and the risk of preterm birth prior to 34 and 37 weeks was 85% and 100%. Cervical dilation is the worst prognostic factor for preterm birth. There are a small number of case reports of cervical cerclage in twin pregnancies with a dilated cervix that suggest similar outcomes to those in singleton pregnancies. The investigators' objective is to determine if physical exam indicated cerclage reduces the incidence of spontaneous preterm birth <34 weeks and improve perinatal outcome in asymptomatic women with twin gestations and dilated cervix (1 to 5 cm) between 16 to 23 6/7 weeks of gestation.

Includes necrotizing enterocolitis, intraventricular hemorrhage (grade 3 or higher), respiratory distress syndrome, bronchopulmonary dysplasia, retinopathy, blood-culture proven sepsis

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 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

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