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Clinical Trials in France / NCT04661553
Recruiting Not applicable

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

NCT04661553 · tracked via the Priya Life Science France tracker
Sponsor
Assistance Publique - Hôpitaux de Paris
Phase
Not applicable
Started
2020-12-22
Last updated
2026-01-21

Condition(s) studied

Pregnancy RelatedPremature Birth

Investigational drug(s) / intervention(s)

Mueller's polarimetric colposcopy "Group 1"Mueller's polarimetric colposcopy "Group 2"

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.

Study 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.

Eligibility

Sex
FEMALE
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * 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. * 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."

Primary outcome measure(s)

  • Polarimetric parameters in population with a low-risk of premature birth — 6 months
    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 — 6 months
    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 — 6 months
    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.

Trial sites (1)

FacilityCityRegionStatus
Hospital Bicêtre - Gynecology-Obstetrics Department Le Kremlin-Bicêtre France Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04661553 on ClinicalTrials.gov ↗ ← All trials in France