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

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ClinicalTrials.gov Identifier: NCT00706264
Recruitment Status : Completed
First Posted : June 27, 2008
Last Update Posted : July 28, 2014
Sponsor:
Collaborators:
Hospital Materno-Infantil de Canarias
Hospital Son Llatzer
Institut Universitari Dexeus
Information provided by (Responsible Party):
Elena Carreras, Maria Goya, Maternal-Infantil Vall d´Hebron Hospital

Study Description
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Brief Summary:
Placement of a vaginal pessary reduces significantly the rate of spontaneous preterm birth in pregnant women with short cervical length at 18-22 weeks scan.

Condition or disease Intervention/treatment Phase
Preterm Birth Device: Silicon ring (Arabin Pessary) Phase 4

Detailed Description:
This trial includes pregnant women undergoing routine ultrasound examination at 18.0 to 22.6 weeks of gestation.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2780 participants
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 (PECEP)
Study Start Date : June 2007
Actual Primary Completion Date : July 2014
Actual Study Completion Date : July 2014
Arms and Interventions
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Arm Intervention/treatment
No Intervention: 1
Expectant management
Experimental: 2
Placement of arabin pessary since 23 weeks until 37 weeks
 Device: Silicon ring (Arabin Pessary)
Placement of a silicon pessary in the vagina, around the cervix.
Other Name: Vaginal pessaries CE 0482 MED / CERT ISO 9003 /EN 46003


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

Secondary Outcome Measures :
  1. Birth weight, Fetal or Neonatal Death, Neonatal morbidity, Maternal adverse effects , Preterm birth before 37 weeks or 28 weeks, Rupture of membranes before 34 weeks, Hospitalisation for threatened preterm labour. [ Time Frame: Each 6 months ]

Eligibility Criteria
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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:

  • Singleton pregnancy
  • Minimal age of 18 years

Exclusion Criteria:

  • Major fetal abnormalities (requiring surgery or leading to infant death or severe handicap)
  • SROM at the time of randomization
  • Cervical cerclage in situ
  • Active vaginal bleeding
  • Previous cone biopsy or cerclage
  • Major uterine structural anomalies
  • Placenta previa
Contacts and Locations
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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): NCT00706264


Locations
Spain
Hospital Materno-Infantil de Canarias
Las Palmas de Gran Canaria, Gran Canaria, Spain, 35016
Hospital de Reus
Reus, Tarragona, Spain
Hospital Vall d´Hebron
Barcelona, Spain, 08035
Institut Universitary Dexeus
Barcelona, Spain
Hospital de Fuenlabrada
Madrid, Spain
Hospital Son Llàtzer
Mallorca, Spain, 07198
Sponsors and Collaborators
Maternal-Infantil Vall d´Hebron Hospital
Hospital Materno-Infantil de Canarias
Hospital Son Llatzer
Institut Universitari Dexeus
Investigators
Study Director: ELENA CARRERAS, PhD Maternal-Infantil Vall d´Hebron Hospital
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Elena Carreras, Maria Goya, PhD, Maternal-Infantil Vall d´Hebron Hospital
ClinicalTrials.gov Identifier: NCT00706264     History of Changes
Other Study ID Numbers: PECEP-TRIAL
First Posted: June 27, 2008    Key Record Dates
Last Update Posted: July 28, 2014
Last Verified: July 2014

Keywords provided by Elena Carreras, Maria Goya, Maternal-Infantil Vall d´Hebron Hospital:
Short cervix
preterm birth
arabin pessary

Additional relevant MeSH terms:
Premature Birth
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications
Silicon
 Trace Elements
Micronutrients
Growth Substances
Physiological Effects of Drugs