Double versus single emergency cervical cerclage combined with vaginal progesterone: a multicenter, nonblinded, randomized controlled trial.

BACKGROUND

Emergency cervical cerclage is used to reduce extreme preterm birth in women with advanced cervical dilatation and exposed fetal membranes. Although double-level cerclage has been proposed to provide greater mechanical support than single-level cerclage, evidence comparing these techniques in emergency settings is limited.

OBJECTIVE

To compare the effectiveness of emergency double-level versus single-level cerclage, both combined with adjunctive vaginal progesterone, antibiotics and indomethacin in preventing delivery before 34 weeks of gestation.

STUDY

DESIGN

This prospective, multicenter, open-label randomized controlled trial was conducted at 7 tertiary perinatal centers in Poland. Women with singleton pregnancies between 16+0 and 25+6 weeks of gestation, advanced cervical dilatation, and visible fetal membranes were randomized 1:1 to single-level or double-level cerclage. All participants received a standardized management protocol including vaginal progesterone, empirical antibiotics (ceftriaxone, clarithromycin, and metronidazole), perioperative indomethacin, and antenatal corticosteroids when indicated. The primary outcome was delivery before 34 weeks of gestation. Secondary outcomes included gestational age at delivery, latency to delivery, maternal complications, and neonatal outcomes. Time-to-event analyses and Cox regression models were applied.

RESULTS

Eighty women underwent emergency cerclage (38 single-level, 42 double-level suture). Delivery before 34 weeks occurred in 27.5% of the overall cohort (23.7% of the single-level group and 31.0% of the double-level cerclage group, P=.53), which was relatively low rate compared with historical reports in women presenting with advanced cervical dilatation and prolapsed membranes. Gestational age at delivery, latency from cerclage placement to delivery, and rates of delivery before 37, 32, and 28 weeks did not differ significantly between groups. Neonatal outcomes, including survival and major morbidity, were comparable. Procedure-related complications were infrequent.

CONCLUSION

In women with advanced cervical insufficiency and exposed fetal membranes, double-level emergency cerclage combined with adjunctive therapy was not found to improve pregnancy prolongation or perinatal outcomes compared with single-level cerclage.