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Pessary Versus Progesterone in Singletons

NCT04300322 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 804

Last updated 2020-10-09

No results posted yet for this study

Summary

This study compares the effectiveness of cervical pessary to vaginal progesterone for prevention of preterm birth in women with singleton pregnancies and a cervix ≤25 mm.

Participants will be randomly assigned in a 1:1 ratio to receive cervical pessary or vaginal progesterone.

Conditions

Interventions

DEVICE

Cervical pessary

Arabin (cervical pessary) will be inserted at 16-22 weeks and removed at 37 weeks of pregnancy or in case of premature rupture of membranes, signs of preterm labour or patient severe discomfort

DRUG

Vaginal Progesterone

Vaginal progesterone (Cyclogest 200 mg) once a day will be used, from 16-22 to 37 weeks of pregnancy or in case of premature rupture of membranes, signs of preterm labour or patient severe discomfort.

Sponsors & Collaborators

  • My Duc Phu Nhuan Hospital HCMC, Vietnam

    collaborator UNKNOWN

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

    collaborator UNKNOWN

  • Mỹ Đức Hospital

    lead OTHER

Principal Investigators

  • Vinh Q Dang, MD · Mỹ Đức Hospital

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-05-01
Primary Completion
2022-03-01
Completion
2022-12-01

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 NCT04300322 on ClinicalTrials.gov