RecruitingNot ApplicableNCT07372495

Cerclage Plus Progesterone vs Progesterone Alone in Twin Short Cervix

Cervical Cerclage Plus Vaginal Progesterone Versus Vaginal Progesterone Alone in Twin Pregnancies With a Short Cervix for Prevention of Preterm Birth: a Randomized Controlled Trial

Sponsor

National Hospital of Obstetrics and Gynecology

Enrollment

260 participants

Start Date

Apr 10, 2026

Study Type

INTERVENTIONAL

Conditions

Preterm

Summary

This study aims to compare the effectiveness of cervical cerclage combined with progesterone versus progesterone alone in preventing preterm birth among women with twin pregnancies and a short cervix (cervical length ≤ 30 mm). Participants will be randomly allocated to either the intervention group (cerclage plus progesterone) or the control group (progesterone alone).

Eligibility

Sex: FEMALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a procedure called Cervical cerclage and a drug called Progesterone for people with preterm. The study is currently recruiting participants at 6 locations. People eligible for this study include women aged 18 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDURECervical cerclage

Participants will receive cervical cerclage according to local protocols within one week after randomization. The procedure will be performed by two to three senior clinicians experienced in cerclage in each center, using the McDonald technique.

DRUGProgesterone

Vaginal micronized progesterone will be administered at a total daily dose of 400 mg, given as Utrogestan® 200 mg (Besins Healthcare, France) twice daily, in the morning and at bedtime. Participants will be asked to record their vaginal progesterone application in a patient diary sheet for up to 140 days.