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Cerclage Plus Progesterone vs Progesterone Alone in Twin Short Cervix
Sponsor: National Hospital of Obstetrics and Gynecology
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).
Official title: 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
Key Details
Gender
FEMALE
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
260
Start Date
2026-03-01
Completion Date
2029-05-30
Last Updated
2026-02-12
Healthy Volunteers
No
Conditions
Interventions
Cervical 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.
Progesterone
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.
Locations (6)
Bac Ninh 1 Obstetrics and Pediatrics Hospital, Bac Ninh, Vietnam
Bắc Ninh, Vietnam
Bac Ninh 2 Obstetrics and Pediatrics Hospital, Bac Ninh, Vietnam
Bắc Ninh, Vietnam
National Hospital of Obstetrics and Gynecology
Hanoi, Vietnam
Hung Yen Obstetrics and Pediatrics Hospital, Hung Yen, Vietnam
Hưng Yên, Vietnam
Ninh Binh Obstetrics and Pediatrics Hospital, Ninh Binh, Vietnam
Ninh Bình, Vietnam
Quang Ninh Obstetrics and Pediatrics Hospital, Quang Ninh, Vietnam
Quang Ninh, Vietnam