Study of Cervix and Inflammation in Preterm Birth Prediction (COLIBRI)

March 28, 2012 updated by: Jean-Charles Pasquier, Université de Sherbrooke

Cervical Assessment by Supracervical, Cervical and Vaginal Markers: Simultaneous Transvaginal Ultrasound and Inflammatory Proteins Detection

Preterm birth rate is 7.2% in Quebec, it's risen worldwide in the past decade and it's the leading cause of perinatal mortality and morbidity. Preterm birth is a major public health problem. Preterm labor leading to preterm birth is difficult to diagnose and prediction of preterm birth is a medical challenge. In the past years, research found that transvaginal ultrasound to assess the cervix of the uterus and vaginal detection of inflammatory protein, specific bacteria and fetal fibronectin can help to detect women at increase risk of preterm delivery. The investigators believe that a combination of these tests can lead to a better prediction of preterm delivery. The investigators want to conduct a study among women judged at increase risk of preterm delivery by their physician (having contractions, modified cervix, past-history of preterm delivery or multiple pregnancy) and assess their cervix by ultrasound and sample their vaginal secretion. The investigators want to analyze the vaginal sampling and look for inflammatory proteins. The objective of this study is to prove the feasibility of this assessment method and elaborate a better predictive test that the investigators can easily use in obstetrics clinics and hospitals.

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

Preterm birth rate in Quebec is 7.2% and, despite extensive research, the rate of preterm birth has risen worldwide over the past decades. Preterm birth is, all over the world, the first cause of perinatal mortality and morbidity. Spontaneous preterm birth (sPTB) groups premature births with intact and ruptured membranes and represents 70% of preterm delivery. The two conditions associated with sPTB share a common physiopathology and a progressive cascade of events. Extensive evidence supports a central role for the production of prostaglandins, inflammatory cytokines and matrix metalloproteinases (MMP) in the cervix and decidua to promote cervical ripening and decidual and fetal membrane activation but, the exact progression of events remains unclear. Several factors were described as risk factor for sPTB like bacterial vaginosis, inflammatory cytokines and fetal fibronectin in vaginal secretions. The transvaginal ultrasound of the cervix (TVUS), which estimates the length and the aspect of the cervix, can be used as predictive factor of preterm birth. To date, no study has addressed the supra-cervical region by transvaginal ultrasound. This region may be an important key of the inflammatory process leading to sPTB. The assessment of this region by ultrasound can be a predictive marker of sPTB. We want to prove the feasibility of this new approach of sPTB prediction : the transvaginal ultrasound assessment of the supracervical and cervical region associated with detection of vaginal inflammation.

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.
Observational

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.
100

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

  • Canada
    • Quebec
      • Sherbrooke, Quebec, Canada
        • Centre Hospitalier Universitaire de Sherbrooke

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

18 years to 45 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

At risk women referred by their physician to the MFM clinic for evaluation of preterm birth risk.

Description

Inclusion Criteria:

  • Live singleton or multiple pregnancy
  • Clinical risk of preterm delivery
  • Pregnancy between 20 and 34 gestational weeks

Exclusion Criteria:

  • Delivery on the day of the ultrasound
  • Major fetal anomaly
  • Previa placentation

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

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
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.
At risk patient for preterm delivery
Patient referred to the MFM clinic for a risk evaluation for preterm delivery.
Procedure: Transvaginal ultrasound
A transvaginal ultrasound with an endocavitary probe will be done as required by the medical condition of the patient. The cervical and supracervical factors will be noted.
Procedure: Vaginal secretion sampling
Vaginal secretion swab will be collected each time patient will have a transvaginal ultrasound. The sample will be centrifuged, frozen and store to be analysed at the end of the study with multiplex antibody arrays.
Other Names:
  • Ray Biotech Multiplex Antibody Arrays

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
Time Frame
Preterm birth < 34 gestational weeks among patient with presence of supracervical factor at ultrasound study.
Time Frame: December 2009
December 2009

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
Time Frame
Presence of inflammatory proteins in vaginal secretion of patient with presence of supracervical factors at transvaginal ultrasound.
Time Frame: December 2009
December 2009
Neonatal morbidity of preterm infant.
Time Frame: December 2009
December 2009

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.
Université de Sherbrooke

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.
  • Principal Investigator: Jean-Charles Pasquier, Md, PhD, Centre de recherche du Centre Hospitalier Universitaire de Sherbrooke

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, 2008

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.
November 1, 2009

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.
December 1, 2009

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).
November 3, 2009

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.
November 3, 2009

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.
November 4, 2009

Study Record Updates

Last Update Posted (Estimate)

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 29, 2012

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 28, 2012

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, 2012

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.
  • 08-020

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