Back to resultsMueller Polarimetric Colposcopy for High-performance Detection of Cervical Changes During Pregnancy (COLPOTERME)
Primary Purpose
Pregnancy Related, Premature Birth
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Mueller's polarimetric colposcopy "Group 1"
Mueller's polarimetric colposcopy "Group 2"
Sponsored by
About this trial
This is an interventional diagnostic trial for Pregnancy Related
Eligibility Criteria
Inclusion Criteria:
- Major patient.
- Single pregnancy.
- Baseline ≥ 20 amenorrhea week and <37 amenorrhea week.
- Dating obtained by ultrasound of the 1st trimester.
Written and informed consent.
- Group 1 (low risk):
Asymptomatic patient benefiting from usual follow-up in the maternity hospital.
> Group 2 (high risk): Symptomatic patient with cervical changes objectified by endovaginal ultrasound of the cervix with an effective length of <20mm.
Asymptomatic patient with a history of premature delivery or late miscarriage and cervical changes objectified by endovaginal ultrasound of the cervix with an effective length of <20mm."
Exclusion Criteria:
- Known uterine malformation or suspected uterine malformation.
- Pregnancy circled.
- Premature rupture of membranes.
- Suspicion of chorioamnionitis.
- Abundant active bleeding hindering the visualization of the cervix.
- History of conization.
- Imminent childbirth.
- Known medical indication at a birth <37 amenorrhea week (severe pre-eclampsia, severe intrauterine growth retardation, hemorrhagic placenta previa, fetal malformations,….).
- Examination of the cervix under speculum not possible.
- Lack of social coverage (AME).
- Limited understanding.
Participation in another intervention research.
> Group1 (Low risk):
- History of spontaneous premature labor.
- History of late miscarriage.
- History of premature rupture of membranes."
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Group1: patients with a low risk of premature birth
Group2: patients with a high risk of premature birth
Arm Description
Asymptomatic patient receiving usual follow-up in the maternity ward.
Symptomatic patients with cervical changes objectified by endovaginal ultrasound of the cervix with length <20mm. Asymptomatic patients with a history of premature delivery or late miscarriage and cervical changes objectified by endovaginal ultrasound of the cervix with length <20mm.
Outcomes
Primary Outcome Measures
Polarimetric parameters in population with a low-risk of premature birth
The principal outcome will be determining the best "polarimetric biomarkers" able to monitor and quantify the uterine cervix's modifications in a population with a low risk of premature birth. Specifically, the "polarimetric biomarkers" are the most relevant polarimetric parameters (or a combination of them) characterizing the cervical microstructure modifications during a normal pregnancy. They can be the main polarimetric parameters obtained from the measured Mueller matrices using different algebraic methods.
One example of a polarimetric parameter that can be assessed is the Phase Retardance, measured in degrees at different wavelengths. It characterizes the anisotropy of the tissue.
Polarimetric biomarkers in population with a low-risk of premature birth
A polarimetric parameter that can be assessed is the azimuth of the Phase Retardance, measured in degrees at different wavelengths. It characterizes the orientations of the microscopic fibrous structures (such as the collagen) in the tissue.
Parameters Polarimetric in population with a low-risk of premature birth
A polarimetric parameter that can be assessed is the Depolarization, measured in arbitrary units at different wavelengths. It characterizes the scattering properties of the tissue.
Secondary Outcome Measures
Polarimetric parameters in population with a high-risk of premature birth
A polarimetric parameter that can be assessed is the azimuth of the Phase Retardance, measured in degrees at different wavelengths. It characterizes the orientations of the microscopic fibrous structures (such as the collagen) in the tissue.
Polarimetric biomarkers in population with a high-risk of premature birth
A polarimetric parameter that can be assessed is the Depolarization, measured in arbitrary units at different wavelengths. It characterizes the scattering properties of the tissue.
Parameters polarimetric in population with a high-risk of premature birth
The principal outcome will be determining the best "polarimetric biomarkers" able to monitor and quantify the uterine cervix's modifications in a population with a high risk of premature birth. Specifically, the "polarimetric biomarkers" are the most relevant polarimetric parameters (or a combination of them) characterizing the cervical microstructure modifications during a normal pregnancy. They can be the main polarimetric parameters obtained from the measured Mueller matrices using different algebraic methods.
One example of a polarimetric parameter that can be assessed is the Phase Retardance, measured in degrees at different wavelengths. It characterizes the anisotropy of the tissue.
Full Information
NCT ID
NCT04661553
First Posted
October 23, 2020
Last Updated
December 3, 2020
Sponsor
Assistance Publique - Hôpitaux de Paris
1. Study Identification
Unique Protocol Identification Number
NCT04661553
Brief Title
Mueller Polarimetric Colposcopy for High-performance Detection of Cervical Changes During Pregnancy
Acronym
COLPOTERME
Official Title
Mueller Polarimetric Colposcopy for High-performance Detection of Cervical Changes During Pregnancy (COLPOTERME)
Study Type
Interventional
2. Study Status
Record Verification Date
October 2020
Overall Recruitment Status
Not yet recruiting
Study Start Date
December 2020 (Anticipated)
Primary Completion Date
May 2024 (Anticipated)
Study Completion Date
May 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique - Hôpitaux de Paris
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
Mueller polarimetric colposcopy appears to be a powerful tool for evaluating cervical microstructure modification during pregnancy. Some polarimetric parameters of the uterine cervix can be correlated with the gestational age. The uterine cervix's polarimetric analysis could make it possible to accurately predict the term of childbirth and be used as a screening tool for preterm birth.
Detailed Description
Interventional research protocol involving the human person relating to a medical device. This is a prospective, not randomized, monocentric study. Prematurity accounts for around 11% of births worldwide. In France, around 60,000 children (7.4%) are born each year prematurely. The term of gestation has a strong impact on mortality, severe neonatal morbidity, and child development. For this reason, premature birth represents a major public health issue. The means to reliably predict a premature birth are still ineffective. The medical device used in this research is a Mueller polarimetric colposcope which appears to be a powerful tool for evaluating the process of remodeling of cervical microstructure during pregnancy.
Mueller polarimetric imaging is the only technique that enables obtaining the comprehensive polarimetric characterization of a sample. Two groups are considered for this study: i) patients at low risk of premature birth (Group 1); ii) patients at high risk of premature birth (Group 2).
This study's main objective is to determine, for the two groups of patients, the best "polarimetric biomarkers" which make it possible to define an optimal "polarimetric score" reflecting the state of the cervical microstructure throughout its remodeling process during pregnancy.
This "Polarimetric Score" will be able to predict the term of childbirth and used as a screening tool for prematurity.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pregnancy Related, Premature Birth
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
683 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Group1: patients with a low risk of premature birth
Arm Type
Experimental
Arm Description
Asymptomatic patient receiving usual follow-up in the maternity ward.
Arm Title
Group2: patients with a high risk of premature birth
Arm Type
Experimental
Arm Description
Symptomatic patients with cervical changes objectified by endovaginal ultrasound of the cervix with length <20mm. Asymptomatic patients with a history of premature delivery or late miscarriage and cervical changes objectified by endovaginal ultrasound of the cervix with length <20mm.
Intervention Type
Device
Intervention Name(s)
Mueller's polarimetric colposcopy "Group 1"
Intervention Description
Determination of the best "polarimetric biomarkers" reflecting the status of the cervical microstructure throughout its remodeling process due to the pregnancy in a population with a low-risk premature birth. This "polarimetric biomarkers" should make it possible to accurately determine the time remaining before childbirth for a normal pregnancy and, therefore, to monitor the regular advancement of the gestation.
Intervention Type
Device
Intervention Name(s)
Mueller's polarimetric colposcopy "Group 2"
Intervention Description
Determination of the best "polarimetric biomarkers" reflecting the status of the cervical microstructure throughout its remodeling process due to the pregnancy in a population at high-risk of preterm birth.
This "polarimetric biomarkers" should make it possible to accurately determine the time remaining before childbirth for an abnormal pregnancy and, therefore, to predict premature childbirth.
Primary Outcome Measure Information:
Title
Polarimetric parameters in population with a low-risk of premature birth
Description
The principal outcome will be determining the best "polarimetric biomarkers" able to monitor and quantify the uterine cervix's modifications in a population with a low risk of premature birth. Specifically, the "polarimetric biomarkers" are the most relevant polarimetric parameters (or a combination of them) characterizing the cervical microstructure modifications during a normal pregnancy. They can be the main polarimetric parameters obtained from the measured Mueller matrices using different algebraic methods.
One example of a polarimetric parameter that can be assessed is the Phase Retardance, measured in degrees at different wavelengths. It characterizes the anisotropy of the tissue.
Time Frame
6 months
Title
Polarimetric biomarkers in population with a low-risk of premature birth
Description
A polarimetric parameter that can be assessed is the azimuth of the Phase Retardance, measured in degrees at different wavelengths. It characterizes the orientations of the microscopic fibrous structures (such as the collagen) in the tissue.
Time Frame
6 months
Title
Parameters Polarimetric in population with a low-risk of premature birth
Description
A polarimetric parameter that can be assessed is the Depolarization, measured in arbitrary units at different wavelengths. It characterizes the scattering properties of the tissue.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Polarimetric parameters in population with a high-risk of premature birth
Description
A polarimetric parameter that can be assessed is the azimuth of the Phase Retardance, measured in degrees at different wavelengths. It characterizes the orientations of the microscopic fibrous structures (such as the collagen) in the tissue.
Time Frame
6 months
Title
Polarimetric biomarkers in population with a high-risk of premature birth
Description
A polarimetric parameter that can be assessed is the Depolarization, measured in arbitrary units at different wavelengths. It characterizes the scattering properties of the tissue.
Time Frame
6 months
Title
Parameters polarimetric in population with a high-risk of premature birth
Description
The principal outcome will be determining the best "polarimetric biomarkers" able to monitor and quantify the uterine cervix's modifications in a population with a high risk of premature birth. Specifically, the "polarimetric biomarkers" are the most relevant polarimetric parameters (or a combination of them) characterizing the cervical microstructure modifications during a normal pregnancy. They can be the main polarimetric parameters obtained from the measured Mueller matrices using different algebraic methods.
One example of a polarimetric parameter that can be assessed is the Phase Retardance, measured in degrees at different wavelengths. It characterizes the anisotropy of the tissue.
Time Frame
6 months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Major patient.
Single pregnancy.
Baseline ≥ 20 amenorrhea week and <37 amenorrhea week.
Dating obtained by ultrasound of the 1st trimester.
Written and informed consent.
Group 1 (low risk):
Asymptomatic patient benefiting from usual follow-up in the maternity hospital.
> Group 2 (high risk): Symptomatic patient with cervical changes objectified by endovaginal ultrasound of the cervix with an effective length of <20mm.
Asymptomatic patient with a history of premature delivery or late miscarriage and cervical changes objectified by endovaginal ultrasound of the cervix with an effective length of <20mm."
Exclusion Criteria:
Known uterine malformation or suspected uterine malformation.
Pregnancy circled.
Premature rupture of membranes.
Suspicion of chorioamnionitis.
Abundant active bleeding hindering the visualization of the cervix.
History of conization.
Imminent childbirth.
Known medical indication at a birth <37 amenorrhea week (severe pre-eclampsia, severe intrauterine growth retardation, hemorrhagic placenta previa, fetal malformations,….).
Examination of the cervix under speculum not possible.
Lack of social coverage (AME).
Limited understanding.
Participation in another intervention research.
> Group1 (Low risk):
History of spontaneous premature labor.
History of late miscarriage.
History of premature rupture of membranes."
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Elodie DEBRAS, Dr
Phone
01 45 21 76 05
Email
elodie.debras@aphp.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Angelo PIERANGELO, Dr
Phone
01 46 69 43 69
Email
angelo.pierangelo@polytechnique.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elodie DEBRAS, Dr
Organizational Affiliation
Obstetrics gynecology department - Bicetre hospital, Kremlin Bicetre, France
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
Mueller Polarimetric Colposcopy for High-performance Detection of Cervical Changes During Pregnancy
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