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An Open Randomised Trial of the Arabin Pessary to Prevent Pre-term Birth in Twin Pregnancy

NCT02235181 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 2228

Last updated 2020-03-25

No results posted yet for this study

Summary

This study aims to determine whether the Arabin cervical pessary prevents preterm birth in women with a twin pregnancy and a short cervix.

Conditions

  • Twin Pregnancy With Antenatal Problem

Interventions

DEVICE

Arabin Cervical Pessary

The Arabin pessary is CE-certified for preventing Spontaneous Preterm Birth (SPB) (CE 0482 / EN ISO 13485: 2003 annex III of the council directive 93/42 EEC) and is being used in this study as per the CE certification and manufacturer's guidance.

Sponsors & Collaborators

  • NHS Lothian

    collaborator OTHER_GOV

  • University of Edinburgh

    lead OTHER

Principal Investigators

  • Jane E Norman, MD · University of Edinburgh

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
16 Years
Max Age
60 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-11-01
Primary Completion
2019-07-31
Completion
2019-10-31

Countries

  • Belgium
  • United Kingdom

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 NCT02235181 on ClinicalTrials.gov