Double versus single emergency cervical cerclage combined with vaginal progesterone: a multicenter, nonblinded, randomized controlled trial.
Katarzyna Kosińska-Kaczyńska, Beata Rebizant, Katarzyna Chaberek et al.
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In 30 seconds
This prospective, multicenter, open-label randomized trial compared single-level with double-level emergency cervical cerclage in women with singleton pregnancies, advanced cervical dilatation, and visible fetal membranes. Both groups also received vaginal progesterone, antibiotics, and indomethacin. Among 80 women, delivery before 34 weeks occurred in 23.7% with single-level and 31.0% with double-level cerclage (P=.53). Gestational age at delivery, latency, other preterm-delivery rates, and neonatal outcomes did not differ significantly. The trial found no improvement in pregnancy prolongation or perinatal outcomes with double-level cerclage.
Key findings
- Delivery before 34 weeks occurred in 23.7% of the single-level group and 31.0% of the double-level group (P=.53).
- Gestational age at delivery, latency to delivery, and rates of delivery before 37, 32, and 28 weeks did not differ significantly.
- Neonatal survival and major morbidity were comparable between groups; procedure-related complications were infrequent.
Why it matters
Emergency cerclage is used in pregnancies at risk of extreme preterm birth when the cervix is advanced in dilatation and membranes are exposed. This randomized comparison addresses whether adding a second suture level improves outcomes when both approaches are paired with the same adjunctive management. The results did not demonstrate an advantage for the more extensive technique in pregnancy prolongation or neonatal outcomes.
What to keep in mind
The trial was open-label and included 80 women, limiting the strength and precision of comparisons, particularly for neonatal outcomes.