- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01242384
Prevention of Preterm Birth Using Cervical Pessary in Pregnant Women After Threatened Preterm Labor(PECEP-RETARD) (PECEP-RETARD)
September 18, 2016 updated by: Maria Goya, MD, PhD, Maternal-Infantil Vall d´Hebron Hospital
Prevention of Preterm Birth Using Cervical Pessary in Pregnant Women After Threatened Preterm Labor
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
500
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Barcelona, Spain, 08036
- Hospital Vall d'Herbron
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 45 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
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).
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: Expectant Management
|
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Experimental: Placement of cervical pessary since 23 weeks until 37 weeks
|
Placement of a silicon pessary in the vagina, around the cervix.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Spontaneous delivery before 34 completed weeks
Time Frame: Each 6 months
|
Each 6 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Birth weight
Time Frame: Each 6 months
|
Each 6 months
|
Fetal-Neonatal Death
Time Frame: Each 6 months
|
Each 6 months
|
Neonatal morbidity
Time Frame: Each 6 months
|
Each 6 months
|
Maternal adverse effects
Time Frame: Each 6 months
|
Each 6 months
|
Preterm birth before 37 weeks or 28 weeks
Time Frame: Each 6 months
|
Each 6 months
|
Rupture of membranes before 34 weeks
Time Frame: Each 6 months
|
Each 6 months
|
Hospitalisation for threatened preterm labour
Time Frame: Each 6 months
|
Each 6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Study Director: Elena Carreras, Hospital Vall d'Hebron
- Principal Investigator: Maria Goya, Hospital Vall d'Hebron
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2008
Primary Completion (Actual)
July 1, 2014
Study Completion (Actual)
July 1, 2014
Study Registration Dates
First Submitted
September 28, 2010
First Submitted That Met QC Criteria
November 15, 2010
First Posted (Estimate)
November 17, 2010
Study Record Updates
Last Update Posted (Estimate)
September 20, 2016
Last Update Submitted That Met QC Criteria
September 18, 2016
Last Verified
September 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PECEP-RETARD TRIAL
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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