Mueller Polarimetric Colposcopy for High-performance Detection of Cervical Changes During Pregnancy

Pregnancy Related Clinical Trial

— COLPOTERME  

Official title:

Mueller Polarimetric Colposcopy for High-performance Detection of Cervical Changes During Pregnancy (COLPOTERME)

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04661553
• Other study ID #: APHP191010
• Secondary ID: 2020-A01932-37
• Status: Not yet recruiting
• Phase: N/A
• Start date: December 2020
• Est. completion date: May 2024

Study information

• Verified date: October 2020
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: Elodie DEBRAS, Dr
• Phone: 01 45 21 76 05
• Email: elodie.debras[@]aphp.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 683
• Est. completion date: May 2024
• Est. primary completion date: May 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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."

Related Conditions & MeSH terms

• Pregnancy Related
• Premature Birth

Intervention

Device:
• Mueller's polarimetric colposcopy "Group 1"
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.
• Mueller's polarimetric colposcopy "Group 2"
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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	6 months
Primary	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.	6 months
Primary	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.	6 months
Secondary	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.	6 months
Secondary	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.	6 months
Secondary	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.	6 months