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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
  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
Intervention Model: Parallel Assignment
Masking: Single (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 Maria Goya, MD, PhD, Maternal-Infantil Vall d´Hebron Hospital:

Primary Outcome Measures:
  • Spontaneous delivery before 34 completed weeks [ Time Frame: Each 6 months ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 137
Study Start Date: January 2011
Study Completion Date: July 2014
Primary Completion Date: July 2014 (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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01242410


Locations
Spain
Hospital Vall d'Herbron
Barcelona, Spain, 08036
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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Maria Goya, MD, PhD, PhD, Maternal-Infantil Vall d´Hebron Hospital
ClinicalTrials.gov Identifier: NCT01242410     History of Changes
Other Study ID Numbers: Pessary in twins TRIAL
First Submitted: September 28, 2010
First Posted: November 17, 2010
Last Update Posted: May 12, 2015
Last Verified: July 2014

Keywords provided by Maria Goya, MD, PhD, 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
Silicon
Trace Elements
Micronutrients
Growth Substances
Physiological Effects of Drugs