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

March 16, 2021 updated by: Maria Goya, MD, PhD, Maternal-Infantil Vall d´Hebron Hospital

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This trial includes pregnant women undergoing routine ultrasound examination at 18.0 to 22.6 weeks of gestation.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
385

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

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

  • Spain
      • Barcelona, Spain, 08035
        • Hospital Vall D´Hebron
      • Barcelona, Spain
        • Institut Universitary Dexeus
      • Madrid, Spain
        • Hospital De Fuenlabrada
    • Gran Canaria
      • Las Palmas de Gran Canaria, Gran Canaria, Spain, 35016
        • Hospital Materno-Infantil de Canarias
    • Mallorca
      • Palma de Mallorca, Mallorca, Spain, 07198
        • Hospital Son Llatzer
    • Tarragona
      • Reus, Tarragona, Spain
        • Hospital de Reus

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years to 41 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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 Names:
  • Vaginal pessaries CE 0482 MED / CERT ISO 9003 /EN 46003

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Spontaneous Delivery Before 34 Completed Weeks
Time Frame: Between 24 and 34 weeks
Number of spontaneous preterm births before 34 weeks occurred in each group.
Between 24 and 34 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Birthweight Less Than 1500 g
Time Frame: Time of delivery
Number of newborns whose birthweight is less than 1500 grams
Time of delivery
Birthweight Less Than 2500 g
Time Frame: Time of delivery
Number of newborns whose birthweight is less than 2500 grams
Time of delivery
Intrauterine Fetal Demise
Time Frame: Pregnancy
The number of fetal deaths in the pessary group was compared to those in the no pessary group
Pregnancy
Neonatal Death
Time Frame: Between birth and 28 days of age
The number of neonatal deaths in the pessary group was compared to those in the no pessary group
Between birth and 28 days of age
Intraventricular Haemorrhage
Time Frame: Between birth and 28 days of age
The number of neonatal intraventricular haemorrhage in the pessary group was compared to those in the no pessary group
Between birth and 28 days of age
Respiratory Distress Syndrome
Time Frame: Between birth and 28 days of age
The number of neonatal Respiratory distress syndrome in the pessary group was compared to those in the no pessary group
Between birth and 28 days of age
Retinopathy of Prematurity
Time Frame: Between birth and 28 days of age
The number of neonatal retinopathy in the pessary group was compared to those in the no pessary group
Between birth and 28 days of age
Necrotising Enterocolitis
Time Frame: Between birth and 28 days of age
The number of neonatal necrotising enterocolitis in the pessary group was compared to those in the no pessary group
Between birth and 28 days of age
Treatment for Sepsis
Time Frame: Between birth and 28 days of age
The number of neonatal cases of treatment needed for sepsis in the pessary group was compared to those in the no pessary group
Between birth and 28 days of age
Composite Adverse Outcomes
Time Frame: Between birth and 28 days of age
The number of neonatal cases with composite adverse outcomes in the pessary group was compared to those in the no pessary group
Between birth and 28 days of age
Spontaneous Delivery Before 28 Completed Weeks
Time Frame: Between 24 and 28 weeks
Number of preterm births before 28 weeks occurred in each group.
Between 24 and 28 weeks
Any Delivery Before 34 Completed Weeks
Time Frame: Between 24 and 34 weeks
Number of all preterm births before 34 weeks occurred in each group.
Between 24 and 34 weeks
Spontaneous Delivery Before 37 Completed Weeks
Time Frame: Between 24 and 37 weeks
Number of preterm births before 37 weeks occurred in each group.
Between 24 and 37 weeks
Gestational Age at Delivery
Time Frame: At time of birth
Number of weeks of gestation completed by time of delivery
At time of birth
Use of Tocolysis
Time Frame: participants will be followed for the duration of pregnancy, up to nine months
Number of participants required use of tocolytic medication
participants will be followed for the duration of pregnancy, up to nine months
Use of Antenatal Steroids
Time Frame: participants will be followed for the duration of pregnancy, up to nine months
Number of participants that received betamethasone to reduce morbidity of expected preterm delivery
participants will be followed for the duration of pregnancy, up to nine months
Chorioamnionitis
Time Frame: participants will be followed for the duration of pregnancy, up to nine months
Number of participants that showed intrauterine infection diagnosed by maternal tachycardia, fever, uterine tenderness, purulent or abnormal cervical discharge, fetal tachycardia.
participants will be followed for the duration of pregnancy, up to nine months
Vaginal Bleeding
Time Frame: participants will be followed for the duration of pregnancy, up to nine months
Number of participants who experienced bleeding from lower genital tract during antepartum period
participants will be followed for the duration of pregnancy, up to nine months
Preterm Premature Rupture of Membranes
Time Frame: participants will be followed for the duration of pregnancy, up to nine months
Number of participants who experienced rupture of membranes as diagnosed by speculum exam showing pooling, ferning, positive nitrazine test, positive amnisure test.
participants will be followed for the duration of pregnancy, up to nine months
Cesarean Delivery
Time Frame: At time of delivery
Number of participants that underwent cesarean delivery
At time of delivery
Vaginal Discharge
Time Frame: participants will be followed for the duration of pregnancy, up to nine months
Number of participants who experienced an increased vaginal discharge.
participants will be followed for the duration of pregnancy, up to nine months
Pessary Repositioning Without Removal
Time Frame: participants will be followed for the duration of pregnancy, up to nine months
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).
participants will be followed for the duration of pregnancy, up to nine months
Pessary Withdrawal
Time Frame: participants will be followed for the duration of pregnancy, up to nine months
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).
participants will be followed for the duration of pregnancy, up to nine months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Maternal-Infantil Vall d´Hebron Hospital

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Hospital Universitario de Canarias
Institut Universitari Dexeus
Hospital Son Llatzer

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: ELENA CARRERAS, PhD, Maternal-Infantil Vall d´Hebron Hospital

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.

General Publications

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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2007

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 1, 2014

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 1, 2014

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 24, 2008

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 26, 2008

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 27, 2008

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 17, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 16, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • PECEP-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.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings