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#Grand Rounds

Does Cerclage for Cervical Dilation Decrease Preterm Birth in Twins?

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BACKGROUND AND PURPOSE:

  • Roman et al. (AJOG, 2020) sought to determine if physical exam-indicated cerclage reduced the incidence of preterm birth in asymptomatic women with twin gestations and cervical dilation prior to 24 weeks

METHODS:

  • Multicenter, parallel-group, open-label, randomized controlled trial
  • Participants
    • Twin pregnancy | 16w0d to 23w6d
    • Asymptomatic cervical dilation from 1 to 5 cm
  • Exclusion criteria
    • Monochorionic-monoamniotic pregnancy | Selective FGR | TTTS | Major fetal and genetic anomalies | Placenta previa | Labor | Chorioamnionitis
  • Randomization 1:1 to 2 groups
    • Cerclage placed under anesthesia
      • Additional interventions such as amnioreduction, indomethacin, antibiotics or suture selection left to physician discretion
    • No cerclage
  • Study design
    • 8 centers | July 2015 to July 2019
    • Data were analyzed as intention to treat
  • Statistical Analysis
    • To detect a reduction in the incidence of PTB < 34 weeks from 80% to 40% with cerclage group
    • Power 80% | Significance level 5%
    • Sample size required: 46 subjects | Total of 52 to account for participant drop out rate
  • Primary outcome
    • Incidence of preterm birth <34 weeks
  • Secondary outcomes
    • Preterm birth <32, <28 and <24 weeks
    • Interval from diagnosis to delivery
    • Perinatal mortality

RESULTS:

  • Following interim analysis, the Data Safety Monitoring Board recommended stopping the trial due to significant decrease in perinatal mortality in the cerclage group
  • A total of 30 women were included
    • Cerclage: 17 women (4 women in this group did not received the surgical procedure)
    • No cerclage: 13 women
  • All women in cerclage group received
    • Indomethacin: 50 to 100mg loading dose followed by 25 to 50 mg every 6 hours for 48 hours
    • Antibiotics: 12 cephalosporin | 1 clindamycin/ gentamycin | 1 azithromycin
  • The incidence of preterm birth was significantly decreased in the cerclage group
    • Preterm birth <34 weeks
      • Cerclage: 70% (12 out of 17 women)
      • No cerclage: 100% (13 out of 13 women)
      • RR 0.71 (95% CI, 0.52 to 0.96)
    • Preterm birth <32 weeks
      • Cerclage: 64.7% (11 out of 17 women)
      • No cerclage: 100% (13 out of 13 women)
      • RR 0.65 (95% CI, 0.46 to 0.92)
    • Preterm birth <28 weeks
      • Cerclage: 41% (7 out of 17 women)
      • No cerclage: 84% (11 out of 13 women)
      • RR 0.49 (95% CI, 0.26 to 0.89)
    • Preterm birth <24 weeks
      • Cerclage: 30% (5 out of 17 women)
      • No cerclage: 84% (11 out of 13 women)
      • RR 0.35 (95% CI, 0.16 to 0.75)
  • The mean gestational age at delivery was later in the cerclage group (p<0.01)
    • Cerclage: 29.05±1.7 weeks
    • No cerclage: 22.5±3.9 weeks
  • The mean interval from diagnosis of cervical dilation to delivery was longer in the cerclage group (p=0.02)
    • Cerclage: 8.3±5.8 weeks
    • No cerclage: 2.9±3.0 weeks
  • Perinatal mortality was significantly reduced in the cerclage group
    • Cerclage: 17.6% (6 out of 34)
    • No cerclage: 77% (20 out of 26)
    • RR 0.22 (95% CI, 0.1 to 0.5)

CONCLUSION:

  • Authors recognize limitations in this study, including sample size that was smaller than initial calculations due to early termination of the trial  
  • Preterm birth was significantly decreased in twin pregnancies that received physical exam-indicated cerclage, indomethacin, and antibiotics <24 weeks
    • 50% decrease in very early preterm birth <28 weeks
    • 78% decrease in perinatal mortality

Learn More – Primary Sources:

Physical Exam Indicated Cerclage in Twin pregnancy: a Randomized Controlled Trial

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Related ObG Topics:

Cervical Cerclage – Professional Recommendations
Preventing Preterm Birth in Twins – What works?
Can Obstetric History Predict Preterm Birth Risk in Twins?
Progesterone, Cerclage or Pessary for Prevention of Preterm Birth: A Comparison

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