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

This study is currently recruiting participants.
Verified July 2011 by Maternal-Infantil Vall d´Hebron Hospital
Sponsor:
Information provided by:
Maternal-Infantil Vall d´Hebron Hospital
ClinicalTrials.gov Identifier:
NCT01242410
First received: September 28, 2010
Last updated: July 24, 2011
Last verified: July 2011
History of Changes

September 28, 2010
July 24, 2011
June 2008
June 2012   (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 NCT01242410 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 With Short Cervix in Twins
Randomized Controlled Trial: Prevention of Preterm Birth Using Cervical Pessary in Pregnant Women With Short Cervix in Twins

Placement of a vaginal pessary reduces significantly the rate of spontaneous preterm birth in pregnant women with twins and a short cervical length at 18-22 weeks scan.

This trial includes pregnant women with twins 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 Cervical Pessary)
Vaginal pessaries CE 0482 MED / CERT ISO 9003 /EN 46003
  • No Intervention: Expectant Management
  • Experimental: Placement of cervical pessary since 23 weeks until 37 weeks
    Intervention: Device: Silicon ring (Arabin Cervical Pessary)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
90
October 2012
June 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Twins
  • Minimal age of 18 years

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: Maria M Goya 934893185 mariagoya@mac.com
Contact: Elena Carreras 934893072 ecarrera@vhebron.net
Spain
 
NCT01242410
Pessary in twins TRIAL
Yes
Elena Carreras Moratonas / 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 M Goya Hospital Vall d'Hebron
Maternal-Infantil Vall d´Hebron Hospital
July 2011

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