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

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
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
  Purpose

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.


Condition Intervention Phase
Preterm Birth
Device: Silicon ring (Arabin Cervical 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: Randomized Controlled Trial: Prevention of Preterm Birth Using Cervical Pessary in Pregnant Women With Short Cervix in Twins

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: 90
Study Start Date: June 2008
Estimated Study Completion Date: October 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: Silicon ring (Arabin Cervical Pessary)
Vaginal pessaries CE 0482 MED / CERT ISO 9003 /EN 46003

Detailed Description:

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

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01242410

Contacts
Contact: Maria M Goya 934893185 mariagoya@mac.com
Contact: Elena Carreras 934893072 ecarrera@vhebron.net

Locations
Spain
Hospital Vall d'Herbron Recruiting
Barcelona, Spain, 08036
Contact: Maria M Goya    934893185    mariagoya@mac.com   
Sponsors and Collaborators
Maternal-Infantil Vall d´Hebron Hospital
Investigators
Study Director: Elena Carreras Hospital Vall d'Hebron
Principal Investigator: Maria M Goya Hospital Vall d'Hebron
  More Information

No publications provided

Responsible Party: Elena Carreras Moratonas / PhD, Maternal-Infantil Vall d´Hebron Hospital
ClinicalTrials.gov Identifier: NCT01242410     History of Changes
Other Study ID Numbers: Pessary in twins TRIAL
Study First Received: September 28, 2010
Last Updated: July 24, 2011
Health Authority: Spain: Spanish Agency of Medicines

Keywords provided by Maternal-Infantil Vall d´Hebron Hospital:
Short cervix
Preterm birth
Cervical pessary
Twins

Additional relevant MeSH terms:
Premature Birth
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications

ClinicalTrials.gov processed this record on April 17, 2014