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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2011 by Maternal-Infantil Vall d´Hebron Hospital.
Recruitment status was  Recruiting
Information provided by:
Maternal-Infantil Vall d´Hebron Hospital Identifier:
First received: September 28, 2010
Last updated: July 24, 2011
Last verified: July 2011

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 ]

Estimated Enrollment: 900
Study Start Date: June 2008
Estimated Study Completion Date: June 2012
Estimated Primary Completion Date: June 2012 (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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01242384

Contact: Maria M Goya 934893185
Contact: Elena Carreras 934893072

Hospital Vall d'Herbron Recruiting
Barcelona, Spain, 08036
Contact: Maria M Goya    934893185   
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

No publications provided

Responsible Party: Elena Carreras Moratonas / 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 24, 2011
Health Authority: Spain: Spanish Agency of Medicines

Additional relevant MeSH terms:
Obstetric Labor, Premature
Premature Birth
Obstetric Labor Complications
Pregnancy Complications
Trace Elements
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions processed this record on July 22, 2014