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

This study has been completed.
Sponsor:
Collaborators:
Hospital Materno-Infantil de Canarias
Hospital Son Llatzer
Institut Universitari Dexeus
Information provided by (Responsible Party):
Elena Carreras, Maria Goya, Maternal-Infantil Vall d´Hebron Hospital
ClinicalTrials.gov Identifier:
NCT00706264
First received: June 24, 2008
Last updated: July 25, 2014
Last verified: July 2014

June 24, 2008
July 25, 2014
June 2007
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 NCT00706264 on ClinicalTrials.gov Archive Site
Birth weight, Fetal or Neonatal Death, Neonatal morbidity, Maternal adverse effects , Preterm birth before 37 weeks or 28 weeks, Rupture of membranes before 34 weeks, 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 With Short Cervix
Randomized Controlled Trial: Prevention of Preterm Birth Using Cervical Pessary in Pregnant Women With Short Cervix (PECEP)

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.

This trial includes pregnant women undergoing routine ultrasound examination at 18.0 to 22.6 weeks of gestation.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
Preterm Birth
Device: Silicon ring (Arabin Pessary)
Placement of a silicon pessary in the vagina, around the cervix.
Other Name: Vaginal pessaries CE 0482 MED / CERT ISO 9003 /EN 46003
  • No Intervention: 1
    Expectant management
  • Experimental: 2
    Placement of arabin pessary since 23 weeks until 37 weeks
    Intervention: Device: Silicon ring (Arabin Pessary)
Goya M, Pratcorona L, Merced C, Rodó C, Valle L, Romero A, Juan M, Rodríguez A, Muñoz B, Santacruz B, Bello-Muñoz JC, Llurba E, Higueras T, Cabero L, Carreras E; Pesario Cervical para Evitar Prematuridad (PECEP) Trial Group. Cervical pessary in pregnant women with a short cervix (PECEP): an open-label randomised controlled trial. Lancet. 2012 May 12;379(9828):1800-6. doi: 10.1016/S0140-6736(12)60030-0. Epub 2012 Apr 3. Erratum in: Lancet. 2012 May 12;379(9828):1790.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
2780
July 2014
July 2014   (final data collection date for primary outcome measure)

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
Female
18 Years to 45 Years
No
Contact information is only displayed when the study is recruiting subjects
Spain
 
NCT00706264
PECEP-TRIAL
Yes
Elena Carreras, Maria Goya, Maternal-Infantil Vall d´Hebron Hospital
Maternal-Infantil Vall d´Hebron Hospital
  • Hospital Materno-Infantil de Canarias
  • Hospital Son Llatzer
  • Institut Universitari Dexeus
Study Director: ELENA CARRERAS, PhD Maternal-Infantil Vall d´Hebron Hospital
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