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Clinical Trials/NCT00706264
NCT00706264CompletedNot Applicable

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

Maternal-Infantil Vall d´Hebron Hospital9 sites in 1 country385 target enrollmentStarted: June 1, 2007Last updated:
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Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
385
Locations
9
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 at 18-22 weeks scan.

Detailed Description

This trial includes pregnant women 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

  • •Singleton pregnancy
  • •Minimal age of 18 years

Exclusion Criteria

  • •Major fetal abnormalities (requiring surgery or leading to infant death or severe handicap)
  • •SROM at the time of randomization
  • •Cervical cerclage in situ
  • •Active vaginal bleeding
  • •Previous cone biopsy or cerclage
  • •Major uterine structural anomalies
  • •Placenta previa

Outcomes

Primary Outcomes

Spontaneous Delivery Before 34 Completed Weeks

Time Frame: Between 24 and 34 weeks

Number of spontaneous preterm births before 34 weeks occurred in each group.

Secondary Outcomes

  • Birthweight Less Than 1500 g(Time of delivery)
  • Birthweight Less Than 2500 g(Time of delivery)
  • Intrauterine Fetal Demise(Pregnancy)
  • Neonatal Death(Between birth and 28 days of age)
  • Intraventricular Haemorrhage(Between birth and 28 days of age)
  • Respiratory Distress Syndrome(Between birth and 28 days of age)
  • Treatment for Sepsis(Between birth and 28 days of age)
  • Composite Adverse Outcomes(Between birth and 28 days of age)
  • Spontaneous Delivery Before 28 Completed Weeks(Between 24 and 28 weeks)
  • Any Delivery Before 34 Completed Weeks(Between 24 and 34 weeks)
  • Spontaneous Delivery Before 37 Completed Weeks(Between 24 and 37 weeks)
  • Gestational Age at Delivery(At time of birth)
  • Use of Tocolysis(participants will be followed for the duration of pregnancy, up to nine months)
  • Use of Antenatal Steroids(participants will be followed for the duration of pregnancy, up to nine months)
  • Chorioamnionitis(participants will be followed for the duration of pregnancy, up to nine months)
  • Vaginal Bleeding(participants will be followed for the duration of pregnancy, up to nine months)
  • Preterm Premature Rupture of Membranes(participants will be followed for the duration of pregnancy, up to nine months)
  • Retinopathy of Prematurity(Between birth and 28 days of age)
  • Necrotising Enterocolitis(Between birth and 28 days of age)
  • Cesarean Delivery(At time of delivery)
  • Vaginal Discharge(participants will be followed for the duration of pregnancy, up to nine months)
  • Pessary Repositioning Without Removal(participants will be followed for the duration of pregnancy, up to nine months)
  • Pessary Withdrawal(participants will be followed for the duration of pregnancy, up to nine 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 (9)

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