We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01242410
First Posted: November 17, 2010
Last Update Posted: May 12, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Maria Goya, MD, PhD, Maternal-Infantil Vall d´Hebron Hospital
September 28, 2010
November 17, 2010
May 12, 2015
January 2011
July 2014   (Final data collection date for primary outcome measure)
Spontaneous delivery before 34 completed weeks [ Time Frame: Each 6 months ]
Same as current
Complete list of historical versions of study NCT01242410 on ClinicalTrials.gov Archive Site
  • 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 ]
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
Intervention Model: Parallel Assignment
Masking: Single (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)
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.
 
Completed
137
July 2014
July 2014   (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
Sexes Eligible for Study: Female
18 Years to 45 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
Spain
 
 
NCT01242410
Pessary in twins TRIAL
Yes
Not Provided
Not Provided
Maria Goya, MD, 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 2014

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