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Prevention of Preterm Birth Using Cervical Pessary in Pregnant Women With Short Cervix (PECEP)

Primary Purpose

Preterm Birth

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
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 focused on measuring Short cervix, preterm birth, arabin pessary

Eligibility Criteria

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

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

Sites / Locations

  • Hospital Materno-Infantil de Canarias
  • Hospital Son Llàtzer
  • Hospital de Reus
  • Hospital Vall d´Hebron
  • Institut Universitary Dexeus
  • Hospital de Fuenlabrada

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

1

2

Arm Description

Expectant management

Placement of arabin pessary since 23 weeks until 37 weeks

Outcomes

Primary Outcome Measures

Spontaneous Delivery Before 34 Completed Weeks
Number of spontaneous preterm births before 34 weeks occurred in each group.

Secondary Outcome Measures

Birthweight Less Than 1500 g
Number of newborns whose birthweight is less than 1500 grams
Birthweight Less Than 2500 g
Number of newborns whose birthweight is less than 2500 grams
Intrauterine Fetal Demise
The number of fetal deaths in the pessary group was compared to those in the no pessary group
Neonatal Death
The number of neonatal deaths in the pessary group was compared to those in the no pessary group
Intraventricular Haemorrhage
The number of neonatal intraventricular haemorrhage in the pessary group was compared to those in the no pessary group
Respiratory Distress Syndrome
The number of neonatal Respiratory distress syndrome in the pessary group was compared to those in the no pessary group
Retinopathy of Prematurity
The number of neonatal retinopathy in the pessary group was compared to those in the no pessary group
Necrotising Enterocolitis
The number of neonatal necrotising enterocolitis in the pessary group was compared to those in the no pessary group
Treatment for Sepsis
The number of neonatal cases of treatment needed for sepsis in the pessary group was compared to those in the no pessary group
Composite Adverse Outcomes
The number of neonatal cases with composite adverse outcomes in the pessary group was compared to those in the no pessary group
Spontaneous Delivery Before 28 Completed Weeks
Number of preterm births before 28 weeks occurred in each group.
Any Delivery Before 34 Completed Weeks
Number of all preterm births before 34 weeks occurred in each group.
Spontaneous Delivery Before 37 Completed Weeks
Number of preterm births before 37 weeks occurred in each group.
Gestational Age at Delivery
Number of weeks of gestation completed by time of delivery
Use of Tocolysis
Number of participants required use of tocolytic medication
Use of Antenatal Steroids
Number of participants that received betamethasone to reduce morbidity of expected preterm delivery
Chorioamnionitis
Number of participants that showed intrauterine infection diagnosed by maternal tachycardia, fever, uterine tenderness, purulent or abnormal cervical discharge, fetal tachycardia.
Vaginal Bleeding
Number of participants who experienced bleeding from lower genital tract during antepartum period
Preterm Premature Rupture of Membranes
Number of participants who experienced rupture of membranes as diagnosed by speculum exam showing pooling, ferning, positive nitrazine test, positive amnisure test.
Cesarean Delivery
Number of participants that underwent cesarean delivery
Vaginal Discharge
Number of participants who experienced an increased vaginal discharge.
Pessary Repositioning Without Removal
Number of participants who required pessary repositioning without removal. This outcome measure only applied to the Experimental (Pessary Arm) and no data were collected from participants in the No Intervention _(No Pessary Arm).
Pessary Withdrawal
Number of participants who experience pessary withdrawal. This outcome measure only applied to the Experimental (Pessary Arm) and no data were collected from participants in the No Intervention _(No Pessary Arm).

Full Information

First Posted
June 24, 2008
Last Updated
March 16, 2021
Sponsor
Maternal-Infantil Vall d´Hebron Hospital
Collaborators
Hospital Universitario de Canarias, Hospital Son Llatzer, Institut Universitari Dexeus
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1. Study Identification

Unique Protocol Identification Number
NCT00706264
Brief Title
Prevention of Preterm Birth Using Cervical Pessary in Pregnant Women With Short Cervix
Acronym
PECEP
Official Title
Randomized Controlled Trial: Prevention of Preterm Birth Using Cervical Pessary in Pregnant Women With Short Cervix (PECEP)
Study Type
Interventional

2. Study Status

Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
June 2007 (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
Collaborators
Hospital Universitario de Canarias, Hospital Son Llatzer, Institut Universitari Dexeus

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 at 18-22 weeks scan.
Detailed Description
This trial includes pregnant women undergoing routine ultrasound examination at 18.0 to 22.6 weeks of gestation.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Preterm Birth
Keywords
Short cervix, preterm birth, arabin pessary

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
385 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
No Intervention
Arm Description
Expectant management
Arm Title
2
Arm Type
Experimental
Arm Description
Placement of arabin pessary since 23 weeks until 37 weeks
Intervention Type
Device
Intervention Name(s)
Silicon ring (Arabin Pessary)
Other Intervention Name(s)
Vaginal pessaries CE 0482 MED / CERT ISO 9003 /EN 46003
Intervention Description
Placement of a silicon pessary in the vagina, around the cervix.
Primary Outcome Measure Information:
Title
Spontaneous Delivery Before 34 Completed Weeks
Description
Number of spontaneous preterm births before 34 weeks occurred in each group.
Time Frame
Between 24 and 34 weeks
Secondary Outcome Measure Information:
Title
Birthweight Less Than 1500 g
Description
Number of newborns whose birthweight is less than 1500 grams
Time Frame
Time of delivery
Title
Birthweight Less Than 2500 g
Description
Number of newborns whose birthweight is less than 2500 grams
Time Frame
Time of delivery
Title
Intrauterine Fetal Demise
Description
The number of fetal deaths in the pessary group was compared to those in the no pessary group
Time Frame
Pregnancy
Title
Neonatal Death
Description
The number of neonatal deaths in the pessary group was compared to those in the no pessary group
Time Frame
Between birth and 28 days of age
Title
Intraventricular Haemorrhage
Description
The number of neonatal intraventricular haemorrhage in the pessary group was compared to those in the no pessary group
Time Frame
Between birth and 28 days of age
Title
Respiratory Distress Syndrome
Description
The number of neonatal Respiratory distress syndrome in the pessary group was compared to those in the no pessary group
Time Frame
Between birth and 28 days of age
Title
Retinopathy of Prematurity
Description
The number of neonatal retinopathy in the pessary group was compared to those in the no pessary group
Time Frame
Between birth and 28 days of age
Title
Necrotising Enterocolitis
Description
The number of neonatal necrotising enterocolitis in the pessary group was compared to those in the no pessary group
Time Frame
Between birth and 28 days of age
Title
Treatment for Sepsis
Description
The number of neonatal cases of treatment needed for sepsis in the pessary group was compared to those in the no pessary group
Time Frame
Between birth and 28 days of age
Title
Composite Adverse Outcomes
Description
The number of neonatal cases with composite adverse outcomes in the pessary group was compared to those in the no pessary group
Time Frame
Between birth and 28 days of age
Title
Spontaneous Delivery Before 28 Completed Weeks
Description
Number of preterm births before 28 weeks occurred in each group.
Time Frame
Between 24 and 28 weeks
Title
Any Delivery Before 34 Completed Weeks
Description
Number of all preterm births before 34 weeks occurred in each group.
Time Frame
Between 24 and 34 weeks
Title
Spontaneous Delivery Before 37 Completed Weeks
Description
Number of preterm births before 37 weeks occurred in each group.
Time Frame
Between 24 and 37 weeks
Title
Gestational Age at Delivery
Description
Number of weeks of gestation completed by time of delivery
Time Frame
At time of birth
Title
Use of Tocolysis
Description
Number of participants required use of tocolytic medication
Time Frame
participants will be followed for the duration of pregnancy, up to nine months
Title
Use of Antenatal Steroids
Description
Number of participants that received betamethasone to reduce morbidity of expected preterm delivery
Time Frame
participants will be followed for the duration of pregnancy, up to nine months
Title
Chorioamnionitis
Description
Number of participants that showed intrauterine infection diagnosed by maternal tachycardia, fever, uterine tenderness, purulent or abnormal cervical discharge, fetal tachycardia.
Time Frame
participants will be followed for the duration of pregnancy, up to nine months
Title
Vaginal Bleeding
Description
Number of participants who experienced bleeding from lower genital tract during antepartum period
Time Frame
participants will be followed for the duration of pregnancy, up to nine months
Title
Preterm Premature Rupture of Membranes
Description
Number of participants who experienced rupture of membranes as diagnosed by speculum exam showing pooling, ferning, positive nitrazine test, positive amnisure test.
Time Frame
participants will be followed for the duration of pregnancy, up to nine months
Title
Cesarean Delivery
Description
Number of participants that underwent cesarean delivery
Time Frame
At time of delivery
Title
Vaginal Discharge
Description
Number of participants who experienced an increased vaginal discharge.
Time Frame
participants will be followed for the duration of pregnancy, up to nine months
Title
Pessary Repositioning Without Removal
Description
Number of participants who required pessary repositioning without removal. This outcome measure only applied to the Experimental (Pessary Arm) and no data were collected from participants in the No Intervention _(No Pessary Arm).
Time Frame
participants will be followed for the duration of pregnancy, up to nine months
Title
Pessary Withdrawal
Description
Number of participants who experience pessary withdrawal. This outcome measure only applied to the Experimental (Pessary Arm) and no data were collected from participants in the No Intervention _(No Pessary Arm).
Time Frame
participants will be followed for the duration of pregnancy, up to nine 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: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
ELENA CARRERAS, PhD
Organizational Affiliation
Maternal-Infantil Vall d´Hebron Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Hospital Materno-Infantil de Canarias
City
Las Palmas de Gran Canaria
State/Province
Gran Canaria
ZIP/Postal Code
35016
Country
Spain
Facility Name
Hospital Son Llàtzer
City
Palma de Mallorca
State/Province
Mallorca
ZIP/Postal Code
07198
Country
Spain
Facility Name
Hospital de Reus
City
Reus
State/Province
Tarragona
Country
Spain
Facility Name
Hospital Vall d´Hebron
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Facility Name
Institut Universitary Dexeus
City
Barcelona
Country
Spain
Facility Name
Hospital de Fuenlabrada
City
Madrid
Country
Spain

12. IPD Sharing Statement

Citations:
PubMed Identifier
22475493
Citation
Goya M, Pratcorona L, Merced C, Rodo C, Valle L, Romero A, Juan M, Rodriguez A, Munoz B, Santacruz B, Bello-Munoz JC, Llurba E, Higueras T, Cabero L, Carreras E; Pesario Cervical para Evitar Prematuridad (PECEP) Trial Group. Cervical pessary in pregnant women with a short cervix (PECEP): an open-label randomised controlled trial. Lancet. 2012 May 12;379(9828):1800-6. doi: 10.1016/S0140-6736(12)60030-0. Epub 2012 Apr 3. Erratum In: Lancet. 2012 May 12;379(9828):1790.
Results Reference
derived

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Prevention of Preterm Birth Using Cervical Pessary in Pregnant Women With Short Cervix

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