CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 81 enrolled
Drug / intervention
Double-level cervical cerclage +1 moreprocedure
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05268640
NCT05268640N/ACompleted

Comparison of the Efficacy of Emergency Double-level and Single Cervical Cerclage in Cervical Insufficiency in the Second Trimester of Pregnancy - Multicenter Prospective Randomized Trial

Centre of Postgraduate Medical Education·interventional·Posted Mar 7, 2022·Updated Sep 30, 2025

In Brief

A clinical study evaluating Double-level cervical cerclage and Single-level cervical cerclage for Cervical Incompetence. Completed, enrolled 81 participants across 7 sites.

Detailed Summary

Cervical insufficiency is defined as painless dilatation of the cervix during the second trimester of pregnancy. As a result of shortening and opening of the cervix, despite the lack of uterine contractions, the fetal membranes invade into the cervical canal and then into the vagina, which results in premature rupture of the membranes and miscarriage or preterm delivery. Cervical insufficiency occurs in approximately 1% of the women. The aim of the study is to evaluate the effectiveness of placing a double-level cervical cerclage in the treatment of advanced cervical insufficiency. The hypothesis assumes that the insertion of a double-level suture is associated with a reduction in the rate of deliveries \< 34 weeks of gestation in comparison to single-level suture. The study will include women with fetal membranes visible through open external os of the cervix between 16+0 and 25+6 weeks. They will be randomized to two arms - McDonald's single cervical cerclage or two-level cerclage.

Study Details

Timeline

N/ACompletedFinished
2023202420252026
First PostedMar 7, 2022
Enrollment StartMar 11, 2022
Primary CompletionMar 10, 2025
TodayJul 2, 2026
Enrollment to primary: 3.0 yearsPosted 4.3 years ago

Interventions

Double-level cervical cerclageprocedure

two cervical sutures + regimen of antibiotics + indomethacin + progesterone

Single-level cervical cerclageprocedure

single cervical suture + regimen of antibiotics + indomethacin + progesterone