Preterm BirthCOLIBRINCT01007513
Study of Cervix and Inflammation in Preterm Birth Prediction
An observational study of Preterm Birth, run by Université de Sherbrooke at 1 site in Canada.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Preterm Birth
- What is being tested?
- Transvaginal ultrasound and Vaginal secretion sampling
- Type of treatment
- Surgery or procedure
- How many people
- 100 participants
- Where
- 1 siteCanada
- Study dates
- Jun 2008to Dec 2009
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: At risk women referred by their physician to the MFM clinic for evaluation of preterm birth risk.
Who may be able to join
- Live singleton or multiple pregnancy
- Clinical risk of preterm delivery
- Pregnancy between 20 and 34 gestational weeks
Who cannot join
- Delivery on the day of the ultrasound
- Major fetal anomaly
- Previa placentation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Preterm Birth
- Being tested
- Transvaginal ultrasound, Vaginal secretion sampling
- Keywords
- Prematurity, Inflammation, Transvaginal ultrasound, Vaginal secretion, Inflammatory process, Neonatal morbidity
- Medical subject headings
- Premature Birth, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transvaginal ultrasoundProcedure or surgery
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.
Vaginal secretion samplingProcedure or surgery
Also called Ray Biotech Multiplex Antibody Arrays
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.
| Study group | Role | What they receive |
|---|---|---|
| At risk patient for preterm delivery | Patient referred to the MFM clinic for a risk evaluation for preterm delivery. Receives: Procedure: Transvaginal ultrasound; Procedure: Vaginal secretion sampling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Preterm birth < 34 gestational weeks among patient with presence of supracervical factor at ultrasound study.
Measured: December 2009
Secondary outcomes (2)
Presence of inflammatory proteins in vaginal secretion of patient with presence of supracervical factors at transvaginal ultrasound.
Measured: December 2009
Neonatal morbidity of preterm infant.
Measured: December 2009
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2009 (estimated)
- Study startJun 2008
- Primary completionNov 2009
- Study completionDec 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Preterm BirthStudies of the same condition, open and under way.
- More trials run by Université de SherbrookeThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Université de Sherbrooke
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jean-Charles Pasquier, Université de Sherbrooke
- Investigators
- Jean-Charles Pasquier, Md, PhD, Principal investigator, Centre de recherche du Centre hospitalier universitaire de Sherbrooke
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01007513
- Sponsor's protocol ID
- 08-020
- Acronym
- COLIBRI
- Status last verified
- Mar 2012
- First submitted
- 3 Nov 2009
- Last updated
- 29 Mar 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Raiche E, Ouellet A, Berthiaume M, Rousseau E, Pasquier JC. Short and inflamed cervix predicts spontaneous preterm birth (COLIBRI study). J Matern Fetal Neonatal Med. 2014 Jul;27(10):1015-9. doi: 10.3109/14767058.2013.847917. Epub 2013 Nov 14.
PubMed 24228627
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cervical Assessment by Supracervical, Cervical and Vaginal Markers: Simultaneous Transvaginal Ultrasound and Inflammatory Proteins Detection
- ClinicalTrials.gov ID
- NCT01007513
- Acronym / sponsor ID
- COLIBRI / 08-020
- Conditions
- Preterm Birth
- Keywords
- Prematurity, Inflammation, Transvaginal ultrasound, Vaginal secretion, Inflammatory process, Neonatal morbidity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Université de SherbrookeUniversity, hospital or other
- Study start
- Jun 2008
- Primary completion
- Nov 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 4 Nov 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| At risk patient for preterm delivery | – | Procedure: Transvaginal ultrasound, Procedure: Vaginal secretion samplingPatient referred to the MFM clinic for a risk evaluation for preterm delivery. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- At risk women referred by their physician to the MFM clinic for evaluation of preterm birth risk.
Key inclusion criteria (3 listed)
- Live singleton or multiple pregnancy
- Clinical risk of preterm delivery
- Pregnancy between 20 and 34 gestational weeks
Key exclusion criteria (3 listed)
- Delivery on the day of the ultrasound
- Major fetal anomaly
- Previa placentation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transvaginal ultrasoundA 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 or surgery | At risk patient for preterm delivery |
| Vaginal secretion samplingAlso: Ray Biotech Multiplex Antibody ArraysVaginal 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. | Procedure or surgery | At risk patient for preterm delivery |
Primary outcome
Preterm birth < 34 gestational weeks among patient with presence of supracervical factor at ultrasound study.
Time frame: December 2009
2 secondary outcomes
Presence of inflammatory proteins in vaginal secretion of patient with presence of supracervical factors at transvaginal ultrasound.
Time frame: December 2009
Neonatal morbidity of preterm infant.
Time frame: December 2009
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2012.
- Derived from this study: PubMed 24228627Raiche E, Ouellet A, Berthiaume M, Rousseau E, Pasquier JC. Short and inflamed cervix predicts spontaneous preterm birth (COLIBRI study). J Matern Fetal Neonatal Med. 2014 Jul;27(10):1015-9. doi: 10.3109/14767058.2013.847917. Epub 2013 Nov 14.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jean-Charles Pasquier, Md, PhD principal investigator
Centre de recherche du Centre hospitalier universitaire de Sherbrooke
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Preterm Birth, run by Université de Sherbrooke at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Mar 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Preterm birth < 34 gestational weeks among patient with presence of supracervical factor at ultrasound study. (time frame: December 2009). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01007513, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Mar 2012.