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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Elena Carreras, Maria Goya, Maternal-Infantil Vall d´Hebron Hospital
ClinicalTrials.gov Identifier:
NCT01242384
First received: September 28, 2010
Last updated: July 25, 2014
Last verified: July 2014

September 28, 2010
July 25, 2014
June 2008
July 2014   (final data collection date for primary outcome measure)
Spontaneous delivery before 34 completed weeks [ Time Frame: Each 6 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01242384 on ClinicalTrials.gov Archive Site
  • 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 ]
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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (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
Female
18 Years to 45 Years
No
Contact information is only displayed when the study is recruiting subjects
Spain
 
NCT01242384
PECEP-RETARD TRIAL
Yes
Elena Carreras, Maria Goya, 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
July 2014

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