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Prevention of Preterm Birth Using Cervical Pessary in Pregnant Women With Short Cervix (PECEP)
This study has been completed.
Sponsor:
Maternal-Infantil Vall d´Hebron Hospital
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
ClinicalTrials.gov Identifier:
NCT00706264
First received: June 24, 2008
Last updated: July 25, 2014
Last verified: July 2014
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Purpose
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 Elena Carreras, Maria Goya, 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.
Eligibility| 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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Please refer to this study by its ClinicalTrials.gov identifier: NCT00706264
Please refer to this study by its ClinicalTrials.gov identifier: 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
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 |
| Study First Received: | June 24, 2008 |
| Last Updated: | July 25, 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 |
ClinicalTrials.gov processed this record on July 21, 2017