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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Premature Birth; Pregnancy Related
• Intervention / Treatment: Device: Mueller's polarimetric colposcopy "Group 1"; Device: Mueller's polarimetric colposcopy "Group 2"

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.

• Study Type: Interventional
• Enrollment (Anticipated): 683
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Elodie DEBRAS, Dr; Phone Number: 01 45 21 76 05; Email: elodie.debras@aphp.fr
• Study Contact Backup: Name: Angelo PIERANGELO, Dr; Phone Number: 01 46 69 43 69; Email: angelo.pierangelo@polytechnique.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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."

Study Plan

How is the study designed?

Design Details

• Primary Purpose: DIAGNOSTIC
• Allocation: NON_RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Group1: patients with a low risk of premature birth; Asymptomatic patient receiving usual follow-up in the maternity ward.	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.
EXPERIMENTAL: Group2: patients with a high risk of premature birth; 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.	Device: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris
• Investigators: Principal Investigator: Elodie DEBRAS, Dr, Obstetrics gynecology department - Bicetre hospital, Kremlin Bicetre, France

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): December 1, 2020
• Primary Completion (ANTICIPATED): May 1, 2024
• Study Completion (ANTICIPATED): May 1, 2024

Study Registration Dates

• First Submitted: October 23, 2020
• First Submitted That Met QC Criteria: December 3, 2020
• First Posted (ACTUAL): December 10, 2020

Study Record Updates

• Last Update Posted (ACTUAL): December 10, 2020
• Last Update Submitted That Met QC Criteria: December 3, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pregnancy Complications; Obstetric Labor Complications; Obstetric Labor, Premature; Premature Birth
• Other Study ID Numbers: APHP191010; 2020-A01932-37 (REGISTRY: IDRCB)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No