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.
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
deliveries below 34+0 weeks of gestation
Timeframe: observation after intervention for 26 weeks of until birth