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

This study has been completed.
Information provided by (Responsible Party):
Elena Carreras, Maria Goya, Maternal-Infantil Vall d´Hebron Hospital Identifier:
First received: September 28, 2010
Last updated: July 25, 2014
Last verified: July 2014
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.

Condition Intervention Phase
Preterm Birth
Device: Device: Silicon ring (Arabin Pessary)
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Prevention of Preterm Birth Using Cervical Pessary in Pregnant Women After Threatened Preterm Labor

Further study details as provided by Maternal-Infantil Vall d´Hebron Hospital:

Primary Outcome Measures:
  • Spontaneous delivery before 34 completed weeks [ Time Frame: Each 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Birth weight [ Time Frame: Each 6 months ] [ Designated as safety issue: No ]
  • Fetal-Neonatal Death [ Time Frame: Each 6 months ] [ Designated as safety issue: No ]
  • Neonatal morbidity [ Time Frame: Each 6 months ] [ Designated as safety issue: No ]
  • Maternal adverse effects [ Time Frame: Each 6 months ] [ Designated as safety issue: No ]
  • Preterm birth before 37 weeks or 28 weeks [ Time Frame: Each 6 months ] [ Designated as safety issue: No ]
  • Rupture of membranes before 34 weeks [ Time Frame: Each 6 months ] [ Designated as safety issue: No ]
  • Hospitalisation for threatened preterm labour [ Time Frame: Each 6 months ] [ Designated as safety issue: No ]

Enrollment: 500
Study Start Date: June 2008
Study Completion Date: July 2014
Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Expectant Management
Experimental: Placement of cervical pessary since 23 weeks until 37 weeks Device: Device: Silicon ring (Arabin Pessary)
Placement of a silicon pessary in the vagina, around the cervix.


Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   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
  Contacts and Locations
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Please refer to this study by its identifier: NCT01242384

Hospital Vall d'Herbron
Barcelona, Spain, 08036
Sponsors and Collaborators
Maternal-Infantil Vall d´Hebron Hospital
Study Director: Elena Carreras Hospital Vall d'Hebron
Principal Investigator: Maria Goya Hospital Vall d'Hebron
  More Information

Responsible Party: Elena Carreras, Maria Goya, PhD, Maternal-Infantil Vall d´Hebron Hospital Identifier: NCT01242384     History of Changes
Other Study ID Numbers: PECEP-RETARD TRIAL 
Study First Received: September 28, 2010
Last Updated: July 25, 2014
Health Authority: Spain: Spanish Agency of Medicines

Additional relevant MeSH terms:
Obstetric Labor, Premature
Premature Birth
Obstetric Labor Complications
Pregnancy Complications processed this record on May 25, 2016