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Physical examination–indicated cerclage in twin pregnancy: a randomized controlled trial

      Background

      Women with twin pregnancies and a dilated cervix in the second trimester are at increased risk of pregnancy loss and early preterm birth; there is currently no proven therapy to prevent preterm birth in this group of women.

      Objective

      This study aimed to determine whether physical examination–indicated cerclage reduces the incidence of preterm birth in women with a diagnosis of twin pregnancies and asymptomatic cervical dilation before 24 weeks of gestation.

      Study Design

      Multicenter, parallel group, open-label, randomized controlled trial of women with twin pregnancies and asymptomatic cervical dilation of 1 to 5 cm between 16 weeks 0/7 days of gestation and 23 weeks 6/7 days of gestation were enrolled from July 2015 to July 2019 in 8 centers. Eligible women were randomized in a 1:1 ratio into either cerclage or no cerclage groups. We excluded women with monochorionic-monoamniotic twin pregnancy, selective fetal growth restriction, twin-twin transfusion syndrome, major fetal malformation, known genetic anomaly, placenta previa, signs of labor, or clinical chorioamnionitis. The primary outcome was the incidence of preterm birth at <34 weeks of gestation. Secondary outcomes were preterm births at <32, <28, and <24 weeks of gestation, interval from diagnosis to delivery, and perinatal mortality. Data were analyzed by intention-to-treat methods.

      Results

      After an interim analysis was performed, the Data and Safety Monitoring Board recommended stopping the trial because of a significant decrease in perinatal mortality in the cerclage group. We randomized 34 women, with 4 women being excluded because of expired informed consent. A total of 17 women were randomized to physical examination–indicated cerclage and 13 women to no cerclage. Whereas 4 women randomized to cerclage did not receive the surgical procedure, no women in the no cerclage group received cerclage. Maternal demographics were not significantly different. All women in the cerclage group also received indomethacin and antibiotics. When comparing the cerclage group vs the no cerclage group, the incidence of preterm birth was significantly decreased as follows: preterm birth at <34 weeks of gestation, 12 of 17 women (70%) vs 13 of 13 women (100%) (risk ratio, 0.71; 95% confidence interval, 0.52–0.96); preterm birth at <32 weeks of gestation, 11 of 17 women (64.7%) vs 13 of 13 women (100%) (risk ratio, 0.65; 95% confidence interval, 0.46–0.92); preterm birth at <28 weeks of gestation, 7 of 17 women (41%) vs 11 of 13 women (84%) (risk ratio, 0.49; 95% confidence interval, 0.26–0.89); and preterm birth at <24 weeks of gestation, 5 of 17 women (30%) vs 11 of 13 women (84%) (risk ratio, 0.35; 95% confidence interval, 0.16–0.75). The mean gestational age at delivery was 29.05±1.7 vs 22.5±3.9 weeks (P<.01), respectively; the mean interval from diagnosis of cervical dilation to delivery was 8.3±5.8 vs 2.9±3.0 weeks (P=.02), respectively. Perinatal mortality was also significantly reduced in the cerclage group compared with the no cerclage group as follows: 6 of 34 women (17.6%) vs 20 of 26 women (77%) (risk ratio, 0.22; 95% confidence interval, 0.1–0.5), respectively.

      Conclusion

      In women with twin pregnancies and asymptomatic cervical dilation before 24 weeks of gestation, a combination of physical examination–indicated cerclage, indomethacin, and antibiotics significantly decreased preterm birth at all evaluated gestational ages. Most importantly, cerclage in this population was associated with a 50% decrease in early preterm birth at <28 weeks of gestation and with a 78% decrease in perinatal mortality.

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      Linked Article

      • The knowledge of cervical length is essential in decision making for cervical cerclage: a response
        American Journal of Obstetrics & GynecologyVol. 224Issue 5
        • Preview
          We appreciate Dr Olus and colleagues’ comments regarding our recent publication, “Physical examination-indicated cerclage in twin pregnancy: a randomized controlled trial.”1 Most enrolling centers were also enrolling for trials, including diamniotic twins with a transvaginal ultrasound cervical length (TVUCL) of <30 mm to pessary, progesterone, or placebo. As part of that research, TVUCL screening was offered to all women with twin pregnancy from 16 to 23 weeks’ gestation. Women who declined participation in the short cervix trials were offered additional TVUCL evaluations and pelvic examinations.
        • Full-Text
        • PDF
      • The knowledge of cervical length is essential in decision making for cervical cerclage
        American Journal of Obstetrics & GynecologyVol. 224Issue 5
        • Preview
          We read with great interest the article by Roman et al,1 who published the multicentric randomized controlled trial results on the use of physical examination–indicated cerclage in asymptomatic twin pregnancies. However, we believe that the study has important methodologic drawbacks.
        • Full-Text
        • PDF
      • Cerclage in twin gestations: the need to consider the effect of antibiotics and indomethacin
        American Journal of Obstetrics & GynecologyVol. 225Issue 1
        • Preview
          We read with interest the paper by Roman et al,1 which reports a randomized controlled trial of cervical cerclage in patients considered to have a physical examination–indicated cerclage. The results of the study reported in the American Journal of Obstetrics and Gynecology are in contrast to those of a systematic review by Rafael et al,2 which reported that cerclage is not an effective intervention to prevent preterm birth or to reduce perinatal death or neonatal morbidity. In addition, ultrasound-indicated cerclage was associated with an increased risk of respiratory distress syndrome, low birthweight, and very low birthweight.
        • Full-Text
        • PDF
      • Reply
        American Journal of Obstetrics & GynecologyVol. 224Issue 1
        • Preview
          We appreciate the comments of Dr Kaur and colleagues1 regarding our recent publication entitled “Physical examination-indicated cerclage in twin pregnancy: a randomized controlled trial.” I agree with Dr Kaur that the AJOG at Glance section should have included the conclusion that the combination of cerclage, indomethacin, and antibiotics was associated with a significantly different perinatal outcome compared with the control. Those 2 therapies were not included in the original protocol. However, most obstetricians adopted the findings in the study of Miller et al.
        • Full-Text
        • PDF
      • Physical examination–indicated cerclage in twin pregnancy: a randomized controlled trial
        American Journal of Obstetrics & GynecologyVol. 224Issue 1
        • Preview
          We read with great interest the study entitled “Physical examination-indicated cerclage in twin pregnancy: a randomized controlled trial” by Roman et al.1 We appreciate the authors for conducting a randomized controlled trial (RCT) on this rare yet enigmatic aspect of twin pregnancy and asymptomatic cervical dilation. However, we wish to make certain observations that will further help in comprehending the results of the study.
        • Full-Text
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