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Prevention of Preterm Birth Using Cervical Pessary in Pregnant Women After Threatened Preterm Labor(PECEP-RETARD) (PECEP-RETARD)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Maria Goya, MD, PhD, Maternal-Infantil Vall d´Hebron Hospital
ClinicalTrials.gov Identifier:
NCT01242384
First received: September 28, 2010
Last updated: September 18, 2016
Last verified: September 2016
  Purpose
Placement of a vaginal pessary reduces significantly the rate of spontaneous preterm birth in pregnant women with short cervical length after an episode of threatened preterm labour.

Condition Intervention Phase
Preterm Birth Device: 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: Prevention of Preterm Birth Using Cervical Pessary in Pregnant Women After Threatened Preterm Labor

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: 500
Study Start Date: June 2008
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: Device: Silicon ring (Arabin Pessary)
Placement of a silicon pessary in the vagina, around the cervix.

  Eligibility

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

Inclusion Criteria:

  • Minimal age of 18 years
  • Episode of threatened preterm labour

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

Sample size: 336 singleton (168 per arm) and 128 twins (64 per arm).

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01242384

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 Goya Hospital Vall d'Hebron
  More Information

Responsible Party: Maria Goya, MD, PhD, PhD, Maternal-Infantil Vall d´Hebron Hospital
ClinicalTrials.gov Identifier: NCT01242384     History of Changes
Other Study ID Numbers: PECEP-RETARD TRIAL
Study First Received: September 28, 2010
Last Updated: September 18, 2016

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

ClinicalTrials.gov processed this record on June 26, 2017