Comparing Cervical Cerclage Plus Vaginal Progesterone Versus Vaginal Progesterone Alone to Prevent Preterm Birth in Women with Singleton Pregnancy and Short Cervix

What this Trial Is About

Researchers are evaluating the effectiveness of cervical cerclage combined with vaginal progesterone compared to vaginal progesterone alone to prevent preterm birth in women who have a single pregnancy and a short cervix measuring 25 mm or less. This open-label, randomized trial involves women between 16 and 24 weeks of pregnancy. Participants are assigned randomly to either receive both treatments or progesterone only, with neonatologists unaware of group assignments to reduce bias. Women in the combined therapy group will undergo the cervical cerclage procedure using the McDonald technique within a week after randomization, followed by daily vaginal progesterone 200 mg at bedtime. The progesterone-only group will receive the same dose of vaginal progesterone daily without cerclage. Both treatments continue until 37 weeks of pregnancy or delivery. Participants will record their progesterone use in a diary. Participants will have initial screening with cervical length measurement and examinations to ensure eligibility and treatment feasibility. Researchers will monitor the time from randomization to delivery as the primary outcome. Secondary outcomes include various neonatal and maternal health measures up to 28 days after birth. Safety will be overseen by an independent committee, with interim analysis planned after 162 participants to evaluate effectiveness and adverse events. The study is expected to continue until October 2026.

Cerclage With Progesterone Versus Progesterone Only in Singleton Pregnancies