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Pessary Versus Cerclage With or Without Progesterone in Twins

NCT03863613 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 219

Last updated 2024-02-20

No results posted yet for this study

Summary

This study compares the effectiveness of cervical pessary and cervical cerclage with or without vaginal progesterone for prevention of preterm birth in women with a twin pregnancy and a cervix ≤28 mm.

Participants will be randomly assigned in a 1:1:1:1 ratio to receive cerclage, pessary, cerclage plus progesterone or pessary plus progesterone.

Conditions

Interventions

DEVICE

Pessary

A soft, flexible, silicone pessary (Arabin®, Dr Arabin GmbH \& Co KG, Germany) will be inserted through the vagina, upward around the cervix.

PROCEDURE

Cervical cerclage

Cervical cerclage using Mc Donald technique, under anaesthesia

DRUG

Vaginal progesterone

Cyclogest® 400mg, Actavis, United Kingdom, applied once daily at bedtime

Sponsors & Collaborators

  • Mỹ Đức Hospital

    lead OTHER

Principal Investigators

  • Yen TN He, MD · My Duc Phu Nhuan Hospital

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
FACTORIAL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-03-23
Primary Completion
2023-07-08
Completion
2023-07-29

Countries

  • Vietnam

Study Locations

More Related Trials

Entities

Diseases

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 NCT03863613 on ClinicalTrials.gov