This multicenter RCT (7 tertiary centers in Poland) compared double-level vs. single-level emergency cervical cerclage — both combined with vaginal progesterone, antibiotics (ceftriaxone, clarithromycin, metronidazole), and indomethacin — in 80 women with singleton pregnancies at 16+0 to 25+6 weeks with advanced cervical dilatation and exposed fetal membranes. The primary outcome was delivery before 34 weeks.
Delivery before 34 weeks occurred in 27.5% overall (23.7% single-level vs. 31.0% double-level; p=0.53). Gestational age at delivery, latency to delivery, rates of delivery before 37/32/28 weeks, neonatal survival, and major morbidity did not differ significantly between groups.
- Small sample (n=80) limits statistical power to detect clinically meaningful differences. - Open-label (non-blinded) design introduces potential performance bias. - Single-country study (Poland) may limit generalizability to other healthcare settings.
Adding a second cerclage suture in emergency settings does not appear to improve pregnancy prolongation or neonatal outcomes over a single suture when adjunctive therapy is standardized. Single-level emergency cerclage combined with vaginal progesterone, antibiotics, and indomethacin remains a reasonable standard of care in this high-risk setting.
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