MedTrace Logo

Randomized Study of Pessary Versus Standard Management in Women With Increased Chance of Premature Birth

NCT00735137 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 2109

Last updated 2021-02-12

No results posted yet for this study

Summary

The aim of the study is to determine the effect of cerclage pessary on the incidence of spontaneous delivery between randomization (at 20-24+6 weeks) and 33+6 weeks in asymptomatic women with singleton pregnancies found at routine mid-trimester screening to have a cervix of \<25 mm in length and in twin pregnancies.

Conditions

Interventions

DEVICE

Vaginal pessary (CE0482, MED/CERT ISO 9003 / EN 46003)

Inserted from randomization till 36-37 weeks of gestation

Sponsors & Collaborators

  • King's College Hospital NHS Trust

    lead OTHER

Principal Investigators

  • Kypros H Nicolaides, Professor · Consultant,Director of the Department of Fetal Medicine

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
16 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2008-08-31
Primary Completion
2012-02-29
Completion
2012-02-29

Countries

  • Austria
  • Brazil
  • Chile
  • Colombia
  • Germany
  • Hong Kong
  • India
  • Italy
  • Portugal
  • Slovenia
  • Spain
  • United Kingdom

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 NCT00735137 on ClinicalTrials.gov