Prevention of Preterm Birth Using Cervical Pessary in Pregnant Women After Threatened Preterm Labor(PECEP-RETARD)

NCT01242384 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 500

Last updated 2016-09-20

No results posted yet for this study

Summary

Placement of a vaginal pessary reduces significantly the rate of spontaneous preterm birth in pregnant women with short cervical length after an episode of threatened preterm labour.

Conditions

Interventions

DEVICE

Device: Silicon ring (Arabin Pessary)

Placement of a silicon pessary in the vagina, around the cervix.

Sponsors & Collaborators

  • Maternal-Infantil Vall d´Hebron Hospital

    lead OTHER

Principal Investigators

  • Elena Carreras · Hospital Vall d'Hebron

  • Maria Goya · Hospital Vall d'Hebron

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-06-30
Primary Completion
2014-07-31
Completion
2014-07-31

Countries

  • Spain

Study Locations

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Entities

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 NCT01242384 on ClinicalTrials.gov