Highlight
- Comparison of double-level versus single-level emergency cervical cerclage combined with vaginal progesterone in women with advanced cervical dilation and exposed fetal membranes.
- No statistically significant difference in delivery before 34 weeks between double-level (31.0%) and single-level cerclage (23.7%).
- Gestational age at delivery, latency, and neonatal outcomes were comparable across intervention groups.
- Procedure-related complications were infrequent, supporting safety of both cerclage techniques with adjunctive therapy.
Study Background
Emergency cervical cerclage is an intrapartum intervention aimed at reducing extreme preterm birth in pregnant women diagnosed with cervical insufficiency characterized by advanced cervical dilation and protruding fetal membranes, a condition associated with significant perinatal morbidity and mortality. Although single-level cerclage is conventionally employed, double-level cerclage has been proposed to provide enhanced mechanical reinforcement of the cervix. The clinical benefit of this approach, however, remains inadequately substantiated, with limited randomized evidence, particularly when combined with adjunctive pharmacological therapy such as vaginal progesterone, antibiotics, and indomethacin. This study addresses the unmet need for rigorous comparative efficacy data to guide management in this high-risk cohort.
Study Design
This was a prospective, multi-center, open-label randomized controlled trial conducted at seven tertiary perinatal centers in Poland. Eligible participants were women with singleton pregnancies between 16+0 and 25+6 weeks of gestation, presenting with advanced cervical dilation and visible fetal membranes. Participants were randomized 1:1 to receive either a single-level emergency cervical cerclage or a double-level cerclage. In both arms, patients received a standardized adjunctive regimen including vaginal progesterone, empirical antibiotics (ceftriaxone, clarithromycin, metronidazole), perioperative indomethacin, and antenatal corticosteroids when clinically indicated. The primary endpoint was delivery before 34 weeks of gestation. Secondary endpoints included gestational age at delivery, latency from cerclage placement to delivery, maternal complications, and neonatal outcomes including survival and major morbidity. Statistical analysis employed time-to-event methods and Cox proportional hazards modeling.
Key Findings
Eighty women underwent emergency cerclage placement: 38 in the single-level group and 42 in the double-level group. The overall rate of delivery before 34 weeks was 27.5%, notably lower than previously reported rates in this severely compromised population. Delivery before 34 weeks occurred in 23.7% of women receiving single-level cerclage and 31.0% in the double-level group, a difference that was not statistically significant (p=0.53). Secondary measures such as gestational age at delivery and latency from cerclage to delivery showed no meaningful differences between groups. Rates of earlier preterm delivery before 37, 32, and 28 weeks were similarly comparable.
Neonatal outcomes, comprising survival rates and incidence of major neonatal morbidities, did not differ significantly between groups, reinforcing equivalence in perinatal safety and efficacy. Importantly, procedure-related complications were rare and evenly distributed, indicating that adding a second cerclage level did not increase procedural risk appreciably.
Expert Commentary
The findings support the clinical equipoise between single- and double-level emergency cerclage when combined with targeted adjunctive therapy including vaginal progesterone and antibiotics. The lack of superiority of double-level cerclage suggests that increased mechanical reinforcement may not translate into meaningful clinical benefit in prolonging pregnancy. This is consistent with the biological plausibility that the adjunctive pharmacotherapies and meticulous patient selection may mitigate risk factors associated with cervical insufficiency beyond the mechanical support alone.
Limitations include the open-label design and sample size, which may not detect subtle differences or rare adverse events. Nonetheless, the multicenter nature enhances generalizability across tertiary care settings. Future research may explore patient subgroups who could preferentially benefit from intensified cerclage techniques or adjuncts, and investigate mechanistic biomarkers to personalize interventions.
Conclusion
In women with advanced cervical insufficiency and exposed fetal membranes, emergency double-level cerclage combined with adjunctive vaginal progesterone, antibiotics, and indomethacin did not demonstrate superior efficacy in preventing preterm delivery before 34 weeks compared to single-level cerclage under similar adjunctive protocols. Both techniques showed low complication rates and comparable neonatal outcomes. This evidence supports the continued use of single-level emergency cerclage with adjunctive therapy as a standard approach pending further research.
Funding and Trial Registration
This investigator-initiated multicenter trial was conducted without commercial sponsorship. Trial registration details were not provided in the source abstract.
References
1. Kosińska-Kaczyńska K, Rebizant B, et al. Double versus single emergency cervical cerclage combined with vaginal progesterone: a multicenter, non-blinded, randomized controlled trial. Am J Obstet Gynecol. 2026 Jul 7. PMID: 42413808.
2. American College of Obstetricians and Gynecologists Practice Bulletin No. 142: Cerclage for the management of cervical insufficiency. Obstet Gynecol. 2014 Feb;123(2 Pt 1):372-9.
3. Berghella V, et al. Cerclage for preventing preterm birth in women with a short cervix detected by ultrasonography: a meta-analysis. Obstet Gynecol. 2011 Jun;117(6):1200-7.
4. McDonald SJ et al. Cervical cerclage for preventing preterm birth in singleton pregnancy. Cochrane Database Syst Rev. 2013;2013(6):CD008991.