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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01242384
First Posted: November 17, 2010
Last Update Posted: September 20, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Maria Goya, MD, PhD, Maternal-Infantil Vall d´Hebron Hospital
September 28, 2010
November 17, 2010
September 20, 2016
June 2008
July 2014   (Final data collection date for primary outcome measure)
Spontaneous delivery before 34 completed weeks [ Time Frame: Each 6 months ]
Same as current
Complete list of historical versions of study NCT01242384 on ClinicalTrials.gov Archive Site
  • Birth weight [ Time Frame: Each 6 months ]
  • Fetal-Neonatal Death [ Time Frame: Each 6 months ]
  • Neonatal morbidity [ Time Frame: Each 6 months ]
  • Maternal adverse effects [ Time Frame: Each 6 months ]
  • Preterm birth before 37 weeks or 28 weeks [ Time Frame: Each 6 months ]
  • Rupture of membranes before 34 weeks [ Time Frame: Each 6 months ]
  • Hospitalisation for threatened preterm labour [ Time Frame: Each 6 months ]
Same as current
Not Provided
Not Provided
 
Prevention of Preterm Birth Using Cervical Pessary in Pregnant Women After Threatened Preterm Labor(PECEP-RETARD)
Prevention of Preterm Birth Using Cervical Pessary in Pregnant Women After Threatened Preterm Labor
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.
Not Provided
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Preterm Birth
Device: Device: Silicon ring (Arabin Pessary)
Placement of a silicon pessary in the vagina, around the cervix.
  • No Intervention: Expectant Management
  • Experimental: Placement of cervical pessary since 23 weeks until 37 weeks
    Intervention: Device: Device: Silicon ring (Arabin Pessary)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
500
July 2014
July 2014   (Final data collection date for primary outcome measure)

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).

Sexes Eligible for Study: Female
18 Years to 45 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
Spain
 
 
NCT01242384
PECEP-RETARD TRIAL
Yes
Not Provided
Not Provided
Maria Goya, MD, PhD, Maternal-Infantil Vall d´Hebron Hospital
Maternal-Infantil Vall d´Hebron Hospital
Not Provided
Study Director: Elena Carreras Hospital Vall d'Hebron
Principal Investigator: Maria Goya Hospital Vall d'Hebron
Maternal-Infantil Vall d´Hebron Hospital
September 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP