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

Primary Purpose

Preterm Birth

Status
Completed
Phase
Phase 4
Locations
Spain
Study Type
Interventional
Intervention
Device: Silicon ring (Arabin Pessary)
Sponsored by
Maternal-Infantil Vall d´Hebron Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Preterm Birth

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleDoes not accept healthy volunteers

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).

Sites / Locations

  • Hospital Vall d'Herbron

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Expectant Management

Placement of cervical pessary since 23 weeks until 37 weeks

Arm Description

Outcomes

Primary Outcome Measures

Spontaneous delivery before 34 completed weeks

Secondary Outcome Measures

Birth weight
Fetal-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

Full Information

First Posted
September 28, 2010
Last Updated
September 18, 2016
Sponsor
Maternal-Infantil Vall d´Hebron Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01242384
Brief Title
Prevention of Preterm Birth Using Cervical Pessary in Pregnant Women After Threatened Preterm Labor(PECEP-RETARD)
Acronym
PECEP-RETARD
Official Title
Prevention of Preterm Birth Using Cervical Pessary in Pregnant Women After Threatened Preterm Labor
Study Type
Interventional

2. Study Status

Record Verification Date
September 2016
Overall Recruitment Status
Completed
Study Start Date
June 2008 (undefined)
Primary Completion Date
July 2014 (Actual)
Study Completion Date
July 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Maternal-Infantil Vall d´Hebron Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Preterm Birth

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
500 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Expectant Management
Arm Type
No Intervention
Arm Title
Placement of cervical pessary since 23 weeks until 37 weeks
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
Device: Silicon ring (Arabin Pessary)
Intervention Description
Placement of a silicon pessary in the vagina, around the cervix.
Primary Outcome Measure Information:
Title
Spontaneous delivery before 34 completed weeks
Time Frame
Each 6 months
Secondary Outcome Measure Information:
Title
Birth weight
Time Frame
Each 6 months
Title
Fetal-Neonatal Death
Time Frame
Each 6 months
Title
Neonatal morbidity
Time Frame
Each 6 months
Title
Maternal adverse effects
Time Frame
Each 6 months
Title
Preterm birth before 37 weeks or 28 weeks
Time Frame
Each 6 months
Title
Rupture of membranes before 34 weeks
Time Frame
Each 6 months
Title
Hospitalisation for threatened preterm labour
Time Frame
Each 6 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility 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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elena Carreras
Organizational Affiliation
Hospital Vall d'Hebron
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Maria Goya
Organizational Affiliation
Hospital Vall d'Hebron
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital Vall d'Herbron
City
Barcelona
ZIP/Postal Code
08036
Country
Spain

12. IPD Sharing Statement

Citations:
PubMed Identifier
30826339
Citation
Merced 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. Erratum In: Am J Obstet Gynecol. 2021 May;224(5):532.
Results Reference
derived

Learn more about this trial

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

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