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Cerclage Plus Progesterone vs Progesterone Alone in Twin Short Cervix

NCT07372495 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 260

Last updated 2026-04-24

No results posted yet for this study

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).

Conditions

  • Preterm

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.

Sponsors & Collaborators

  • Quang Ninh Obstetrics and Pediatrics Hospital, Quang Ninh, Vietnam

    collaborator OTHER

  • Ninh Binh Obstetrics and Pediatrics Hospital, Ninh Binh, Vietnam

    collaborator OTHER

  • Bac Ninh 1 Obstetrics and Pediatrics Hospital, Bac Ninh, Vietnam

    collaborator UNKNOWN

  • Bac Ninh 2 Obstetrics and Pediatrics Hospital, Bac Ninh, Vietnam

    collaborator UNKNOWN

  • Hung Yen Obstetrics and Pediatrics Hospital, Hung Yen, Vietnam

    collaborator UNKNOWN

  • National Hospital of Obstetrics and Gynecology

    lead OTHER

Principal Investigators

  • Anh D Nguyen, Prof, MD,PhD · National Hospital of Obstetrics and Gynecology

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-04-10
Primary Completion
2028-12-30
Completion
2029-05-30

Countries

  • Vietnam

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07372495 on ClinicalTrials.gov