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NOT YET RECRUITING
NCT07372495
NA

Cerclage Plus Progesterone vs Progesterone Alone in Twin Short Cervix

Sponsor: National Hospital of Obstetrics and Gynecology

View on ClinicalTrials.gov

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

PROCEDURE

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.

DRUG

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