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Clinical Trials/NCT01242384
NCT01242384
Completed
Phase 4

Prevention of Preterm Birth Using Cervical Pessary in Pregnant Women After Threatened Preterm Labor

Maternal-Infantil Vall d´Hebron Hospital1 site in 1 country500 target enrollmentJune 2008
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ConditionsPreterm Birth

Overview

Phase
Phase 4
Intervention
Not specified
Conditions
Preterm Birth
Sponsor
Maternal-Infantil Vall d´Hebron Hospital
Enrollment
500
Locations
1
Primary Endpoint
Spontaneous delivery before 34 completed weeks
Status
Completed
Last Updated
9 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

Overview

Brief 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.

Registry
clinicaltrials.gov
Start Date
June 2008
End Date
July 2014
Last Updated
9 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

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

Maria Goya, MD, PhD

PhD

Maternal-Infantil Vall d´Hebron Hospital

Eligibility Criteria

Inclusion Criteria

  • •Minimal age of 18 years
  • •Episode of threatened preterm labour

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
  • •Sample size: 336 singleton (168 per arm) and 128 twins (64 per arm).

Outcomes

Primary Outcomes

Spontaneous delivery before 34 completed weeks

Time Frame: Each 6 months

Secondary Outcomes

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

Study Sites (1)

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