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

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ClinicalTrials.gov Identifier: NCT01242410
Recruitment Status : Completed
First Posted : November 17, 2010
Last Update Posted : May 12, 2015
Sponsor:
Information provided by (Responsible Party):
Maria Goya, MD, PhD, Maternal-Infantil Vall d´Hebron Hospital

Tracking Information
First Submitted Date  ICMJE September 28, 2010
First Posted Date  ICMJE November 17, 2010
Last Update Posted Date May 12, 2015
Study Start Date  ICMJE January 2011
Actual Primary Completion Date July 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 15, 2010)
Spontaneous delivery before 34 completed weeks [ Time Frame: Each 6 months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 15, 2010)
  • 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 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Prevention of Preterm Birth Using Cervical Pessary in Pregnant Women With Short Cervix in Twins
Official Title  ICMJE Randomized Controlled Trial: Prevention of Preterm Birth Using Cervical Pessary in Pregnant Women With Short Cervix in Twins
Brief Summary 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.
Detailed Description This trial includes pregnant women with twins undergoing routine ultrasound examination at 18.0 to 22.6 weeks of gestation.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE Preterm Birth
Intervention  ICMJE Device: Silicon ring (Arabin Cervical Pessary)
Vaginal pessaries CE 0482 MED / CERT ISO 9003 /EN 46003
Study Arms  ICMJE
  • No Intervention: Expectant Management
  • Experimental: Placement of cervical pessary since 23 weeks until 37 weeks
    Intervention: Device: Silicon ring (Arabin Cervical Pessary)
Publications * Goya M, de la Calle M, Pratcorona L, Merced C, Rodó C, Muñoz B, Juan M, Serrano A, Llurba E, Higueras T, Carreras E, Cabero L; PECEP-Twins Trial Group. Cervical pessary to prevent preterm birth in women with twin gestation and sonographic short cervix: a multicenter randomized controlled trial (PECEP-Twins). Am J Obstet Gynecol. 2016 Feb;214(2):145-152. doi: 10.1016/j.ajog.2015.11.012. Epub 2015 Nov 25.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 25, 2014)
137
Original Estimated Enrollment  ICMJE
 (submitted: November 15, 2010)
90
Actual Study Completion Date  ICMJE July 2014
Actual Primary Completion Date July 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 45 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Spain
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01242410
Other Study ID Numbers  ICMJE Pessary in twins TRIAL
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Maria Goya, MD, PhD, Maternal-Infantil Vall d´Hebron Hospital
Study Sponsor  ICMJE Maternal-Infantil Vall d´Hebron Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Elena Carreras Hospital Vall d'Hebron
Principal Investigator: Maria M Goya Hospital Vall d'Hebron
PRS Account Maternal-Infantil Vall d´Hebron Hospital
Verification Date July 2014

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