Twin pregnancies in the United States represent a small proportion of births each year, but they are associated with increased risks of preterm birth (PTB), low birthweight, and perinatal mortality. In the setting of cervical dilation in the second trimester, the risks for complications in a twin pregnancy are even higher. In singleton pregnancies, physical examinationindicated cerclage has been shown to decrease PTB and loss of pregnancy. However, the data for this procedure in twin pregnancies are limited. There has been 1 prior randomized controlled trial (RCT) to examine cerclage for cervical dilation in pregnant women. The RCT compared 13 women who received cerclage, indomethacin, and bed rest with 10 women on bed-rest only. Although the RCT included some twin pregnancies (3 in the cerclage group and 4 in the bed-rest only group), these data were not reported separately. In addition, 3 retrospective, case-controlled studies on twin pregnancies with and without cerclage found decreases in spontaneous PTBs and perinatal mortality. The aim of this study is to assess whether physical examination-indicated cerclage could reduce the rate of PTBs in women with twin pregnancies and cervical dilation in the second trimester.This was a parallel-group, open-label RCT conducted between July 2015 and July 2019 at 8 clinical centers. Included were 18-to 50-year-old women with twin pregnancies and asymptomatic cervical dilation of 1 cm to 5 cm between 16 weeks' gestation and 23 weeks, 6/7 days' gestation. Excluded were women with monochorionic gestations, selective fetal growth restriction, known genetic anomaly or fetal malformation, twin-twin transfusion syndrome, placenta previa, and indications of labor. Women were randomly assigned to either the cerclage group or no-cerclage group. Although the use of indomethacin and antibiotics were at the discretion of the physician, all women who underwent cerclage received them. During interim analysis, the study was stopped due to significant decreases in the rate of perinatal death in the cerclage group.Of the 30 women included in the analysis, 17 were in the cerclage group and 13 in the no-cerclage group. At <34 weeks' gestation, spontaneous PTBs occurred in 12 women in the cerclage group and 13 in the no-cerclage group (70.6% vs 100%, respectively; risk ratio [RR], 0.7; 95% confidence interval [CI], 0.46-0.96; P = 0.05). Significant decreases in PTBs were also observed at <32, <28, and <24 weeks' gestation in the cerclage group versus no-cerclage group (64.
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