NCT04661553

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

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 683 (estimated)
• Sponsor: Assistance Publique - Hôpitaux de Paris · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Pregnancy Related
• Premature Birth

Interventions

Type	Name	Description
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.
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.

Timeline

• Start date: 2020-12-22
• Primary completion: 2026-04-01
• Completion: 2026-12-01
• First posted: 2020-12-10
• Last updated: 2026-01-21

Locations

1 site across 1 country: France