692: Physical exam indicated cerclage in twin pregnancy, randomized clinical trial

Abstract

Twin pregnancies with dilated cervix in the second trimester are at increased risk of pregnancy loss and preterm birth (PTB); there is no proven therapy to prevent PTB in this group of women. We aimed to evaluate if physical exam indicated cerclage reduces the incidence of PTB in asymptomatic women with twin gestations and cervical dilation < 24 weeks Multicenter open label randomized clinical trial of women with twin pregnancy and asymptomatic cervical dilation from 1-4 cm between 16 0/7 to 23 6/7 weeks were enrolled from 5/2015 to 7/2019 in 8 centers. They were randomized to cerclage or no cerclage. Exclusion criteria: monoamniotic pregnancy, fetal growth restriction, twin-twin transfusion syndrome, major fetal malformations, known genetic anomaly, signs of labor or clinical chorioamnionitis. Primary outcome: incidence of PTB < 34 weeks. Secondary outcomes: PTB < 32, < 28 and < 24 weeks, interval from diagnosis to delivery and perinatal mortality. Data was analyzed as intention to treat 30 women were enrolled. 17 women were randomized to cerclage and 13 women to no cerclage. 4 women in the cerclage group did not receive the surgical procedure. Maternal demographics were not significantly different, more women in the cerclage group received indomethacin and antibiotics (Table 1). When comparing cerclage group vs no cerclage group, the incidence of PTB < 34 weeks was significantly reduced in the cerclage group: 12/17 (70%) vs 13/13 (100%) RR: 0.7 [95% CI 0.5-0.96], PTB < 32, < 28, and < 24 weeks were all significantly reduced in the cerclage group by 36%, 52% and 65% respectively. Interval from diagnosis to delivery: 8.3±5.8 vs 2.9±3.0 weeks (p=0.02). Perinatal death was significantly reduced in the cerclage group by 77% (Table 2) In this randomized trial, physical exam indicated cerclage, indomethacin and antibiotics in asymptomatic twin pregnancies with dilated cervix < 24 weeks significantly decreased PTB at all evaluated gestational ages, most importantly cerclage decreased very early PTB < 28 weeks by 52% and perinatal mortality by 77%, compared with no cerclageView Large Image Figure ViewerDownload Hi-res image Download (PPT)