Mueller Polarimetric Colposcopy for High-performance Detection of Cervical Changes During Pregnancy
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorAssistance Publique - Hôpitaux de Paris
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Major patient.
Single pregnancy.
Baseline ≥ 20 amenorrhea week for group 1 and baseline ≥ 20 amenorrhea week and <37 amenorrhea week for group 2.
Dating obtained by ultrasound of the 1st trimester.
Disqualifiers
Known uterine malformation or suspected uterine malformation.
Pregnancy circled.
Premature rupture of membranes.
Suspicion of chorioamnionitis.
Trial design
Design model
Parallel
Treatments tested in this trial
Mueller's polarimetric colposcopy "Group 1"
DeviceDetermination 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.
Mueller's polarimetric colposcopy "Group 2"
DeviceDetermination 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.
Treatment groups
683 Participants
are divided into 2 treatment groupsGroup A: Group1: patients with a low risk of premature birthExperimental treatment 1 intervention
Group B: Group2: patients with a high risk of premature birthExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
6 months2
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.
Time frame
6 months3
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.
Time frame
6 monthsSecondary outcomes
1
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.
Time frame
6 months2
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.
Time frame
6 months3
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.
Time frame
6 monthsSponsors and contacts
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Source ClinicalTrials.gov