Skip to main content
MedPath Trial logoMedPath TrialMedPath Trial Home
Clinical Trials/NCT01242410
NCT01242410CompletedPhase 4

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

Maternal-Infantil Vall d´Hebron Hospital2 sites in 1 country137 target enrollmentStarted: January 1, 2011Last updated:
Share to TwitterShare to FacebookShare to LinkedInShare to Reddit
Conditions

Trial Snapshot

Phase
Phase 4
Status
Completed
Sponsor
Enrollment
137
Locations
2
Primary Endpoint
Spontaneous delivery before 34 completed weeks
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

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.

Detailed Description

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

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Prevention
Masking
Single (Outcomes Assessor)

Eligibility Criteria

Ages
18 Years to 45 Years (Adult)
Sex
Female
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •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

Outcomes

Primary Outcomes

Spontaneous delivery before 34 completed weeks

Time Frame: Each 6 months

Secondary Outcomes

  • Birth weight(Each 6 months)
  • Fetal-Neonatal Death(Each 6 months)
  • Neonatal morbidity(Each 6 months)
  • Preterm birth before 37 weeks or 28 weeks(Each 6 months)
  • Rupture of membranes before 34 weeks(Each 6 months)
  • Hospitalisation for threatened preterm labour(Each 6 months)
  • Maternal adverse effects(Each 6 months)

Investigators

Sponsor
Maternal-Infantil Vall d´Hebron Hospital
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Maria Goya, MD, PhD

PhD

Maternal-Infantil Vall d´Hebron Hospital

Study Sites (2)

Loading locations...

Similar Trials

Completed
Not Applicable
Prevention of Preterm Birth Using Cervical Pessary in Pregnant Women With Short CervixPreterm Birth
NCT00706264Maternal-Infantil Vall d´Hebron Hospital385
Completed
Phase 4
Prevention of Preterm Birth Using Cervical Pessary in Pregnant Women After Threatened Preterm Labor(PECEP-RETARD)Preterm Birth
NCT01242384Maternal-Infantil Vall d´Hebron Hospital500
Completed
Not Applicable
Cervical pessary for the prevention of preterm delivery.Preterm Delivery
JPRN-UMIN000025404Department of Obstetrics and Gynecology Nagoya City University, Graduate School of Medical Sciences237
Completed
Phase 2
OVE MOM trialPreterm Labor
JPRN-jRCTs042180102Ozaki Yasuhiko237
Recruiting
Not Applicable
PC-studypreterm birthhistory of preterm birth short cervical length
NL-OMON26958Academic Medical Center Amsterdam440
Prevention of Preterm Birth Using Cervical... | Clinical Trial