Prevention of Preterm Birth Using Cervical Pessary in Pregnant Women With Short Cervix in Twins (PECEP-TWINS)

May 9, 2015 updated by: Maria Goya, MD, PhD, Maternal-Infantil Vall d´Hebron Hospital

Randomized Controlled Trial: Prevention of Preterm Birth Using Cervical Pessary in Pregnant Women With Short Cervix in Twins

Placement of a vaginal pessary reduces significantly the rate of spontaneous preterm birth in pregnant women with twins and a short cervical length at 18-22 weeks scan.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This trial includes pregnant women with twins undergoing routine ultrasound examination at 18.0 to 22.6 weeks of gestation.

Study Type

Interventional

Enrollment (Actual)

137

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Barcelona, Spain, 08036
        • Hospital Vall d'Herbron

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Twins
  • Minimal age of 18 years

Exclusion Criteria:

  • Major fetal abnormalities (requiring surgery or leading to infant death or severe handicap)
  • Spontaneous rupture of membranes at the time of randomization
  • Cervical cerclage in situ
  • Active vaginal bleeding
  • Placenta previa

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Expectant Management
Experimental: Placement of cervical pessary since 23 weeks until 37 weeks
Device: Silicon ring (Arabin Cervical Pessary)
Vaginal pessaries CE 0482 MED / CERT ISO 9003 /EN 46003

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Spontaneous delivery before 34 completed weeks
Time Frame: Each 6 months
Each 6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Birth weight
Time Frame: Each 6 months
Each 6 months
Fetal-Neonatal Death
Time Frame: Each 6 months
Each 6 months
Neonatal morbidity
Time Frame: Each 6 months
Each 6 months
Maternal adverse effects
Time Frame: Each 6 months
Each 6 months
Preterm birth before 37 weeks or 28 weeks
Time Frame: Each 6 months
Each 6 months
Rupture of membranes before 34 weeks
Time Frame: Each 6 months
Each 6 months
Hospitalisation for threatened preterm labour
Time Frame: Each 6 months
Each 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Maternal-Infantil Vall d´Hebron Hospital

Investigators

  • Study Director: Elena Carreras, Hospital Vall d'Hebron
  • Principal Investigator: Maria M Goya, Hospital Vall d'Hebron

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2011

Primary Completion (Actual)

July 1, 2014

Study Completion (Actual)

July 1, 2014

Study Registration Dates

First Submitted

September 28, 2010

First Submitted That Met QC Criteria

November 15, 2010

First Posted (Estimate)

November 17, 2010

Study Record Updates

Last Update Posted (Estimate)

May 12, 2015

Last Update Submitted That Met QC Criteria

May 9, 2015

Last Verified

July 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Pessary in twins TRIAL

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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