Prevention of Preterm Birth Using Cervical Pessary in Pregnant Women After Threatened Preterm Labor(PECEP-RETARD)
PECEP-RETARD
1 other identifier
interventional
500
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Jun 2008
Longer than P75 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2008
CompletedFirst Submitted
Initial submission to the registry
September 28, 2010
CompletedFirst Posted
Study publicly available on registry
November 17, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2014
CompletedSeptember 20, 2016
September 1, 2016
6.1 years
September 28, 2010
September 18, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
Spontaneous delivery before 34 completed weeks
Each 6 months
Secondary Outcomes (7)
Birth weight
Each 6 months
Fetal-Neonatal Death
Each 6 months
Neonatal morbidity
Each 6 months
Maternal adverse effects
Each 6 months
Preterm birth before 37 weeks or 28 weeks
Each 6 months
- +2 more secondary outcomes
Study Arms (2)
Expectant Management
NO INTERVENTIONPlacement of cervical pessary since 23 weeks until 37 weeks
EXPERIMENTALInterventions
Placement of a silicon pessary in the vagina, around the cervix.
Eligibility Criteria
You may qualify if:
- Minimal age of 18 years
- Episode of threatened preterm labour
You may not qualify if:
- 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).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hospital Vall d'Herbron
Barcelona, Barcelona, 08036, Spain
Related Publications (2)
Abdel-Aleem H, Shaaban OM, Abdel-Aleem MA, Aboelfadle Mohamed A. Cervical pessary for preventing preterm birth in singleton pregnancies. Cochrane Database Syst Rev. 2022 Dec 1;12(12):CD014508. doi: 10.1002/14651858.CD014508.
PMID: 36453699DERIVEDMerced C, Goya M, Pratcorona L, Rodo C, Llurba E, Higueras T, Cabero L, Carreras E; PECEP-RETARD Trial Group. Cervical pessary for preventing preterm birth in twin pregnancies with maternal short cervix after an episode of threatened preterm labor: randomised controlled trial. Am J Obstet Gynecol. 2019 Jul;221(1):55.e1-55.e14. doi: 10.1016/j.ajog.2019.02.035. Epub 2019 Feb 28.
PMID: 30826339DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Elena Carreras
Hospital Vall d'Hebron
- PRINCIPAL INVESTIGATOR
Maria Goya
Hospital Vall d'Hebron
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- PhD
Study Record Dates
First Submitted
September 28, 2010
First Posted
November 17, 2010
Study Start
June 1, 2008
Primary Completion
July 1, 2014
Study Completion
July 1, 2014
Last Updated
September 20, 2016
Record last verified: 2016-09