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Clinical Trials/NCT01242384
NCT01242384CompletedPhase 4

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

Maternal-Infantil Vall d´Hebron Hospital2 sites in 1 country500 target enrollmentStarted: June 1, 2008Last updated:
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Conditions

Trial Snapshot

Phase
Phase 4
Status
Completed
Sponsor
Enrollment
500
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 short cervical length after an episode of threatened preterm labour.

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
  • •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)

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)

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Prevention of Preterm Birth Using Cervical... | Clinical Trial