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

This study has been completed.
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 Identifier:
First received: June 24, 2008
Last updated: July 25, 2014
Last verified: July 2014
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 Intervention Phase
Preterm Birth
Device: Silicon ring (Arabin Pessary)
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
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 (PECEP)

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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 2780
Study Start Date: June 2007
Study Completion Date: July 2014
Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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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Please refer to this study by its identifier: NCT00706264

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
Study Director: ELENA CARRERAS, PhD Maternal-Infantil Vall d´Hebron Hospital
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Elena Carreras, Maria Goya, PhD, Maternal-Infantil Vall d´Hebron Hospital Identifier: NCT00706264     History of Changes
Other Study ID Numbers: PECEP-TRIAL
Study First Received: June 24, 2008
Last Updated: July 25, 2014

Keywords provided by 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
Trace Elements
Growth Substances
Physiological Effects of Drugs processed this record on May 22, 2017