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Researchers are investigating ways to prevent preterm birth in women with twin pregnancies who have a short cervix measuring 30 mm or less. This study compares two treatments: cervical cerclage combined with vaginal progesterone versus vaginal progesterone alone. Twin pregnancies carry a higher risk of early birth, which can lead to serious health problems for babies, including increased chances of infections, developmental disorders, and long-term complications. The trial addresses the need for better evidence on effective treatments in this population. Participants will be randomly assigned to one of two groups. One group will receive a cervical cerclage procedure, where a suture is placed around the cervix using the McDonald technique before 24 weeks of pregnancy, along with daily vaginal progesterone at a dose of 400 mg. The other group will receive only the vaginal progesterone at the same dose. The progesterone is taken twice daily from shortly after randomization until 37 weeks of pregnancy or delivery, whichever comes first. The cerclage procedure will be done by experienced obstetricians, with antibiotic prophylaxis given before surgery. Women in the study will have cervical length measured between 16 and 24 weeks via transvaginal ultrasound. Follow-up visits will occur one week after randomization and then every two weeks until delivery. During visits, doctors will check cervical length, treatment compliance, and any complications. Participants will keep a diary to record progesterone use. The main outcome measured is the rate of preterm birth before 28 weeks. Data on maternal and newborn health, as well as hospital costs, will also be collected. If delivery occurs at non-study hospitals, outcome information will be gathered by phone and medical records.

Age: 18Years +FEMALEPhase Not Applicable
6 locations
Tan Thuan Binh Clinical Trials | DecenTrialz