NCT04661553

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
683

participants targeted

Target at P75+ for not_applicable

Timeline
7mo left

Started Dec 2020

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress90%
Dec 2020Dec 2026

First Submitted

Initial submission to the registry

October 23, 2020

Completed
2 months until next milestone

First Posted

Study publicly available on registry

December 10, 2020

Completed
12 days until next milestone

Study Start

First participant enrolled

December 22, 2020

Completed
5.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2026

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2026

Expected
Last Updated

January 21, 2026

Status Verified

January 1, 2026

Enrollment Period

5.3 years

First QC Date

October 23, 2020

Last Update Submit

January 19, 2026

Conditions

Pregnancy RelatedPremature Birth

Outcome Measures

Primary Outcomes (3)

  • 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 Outcomes (3)

  • Polarimetric parameters in population with a high-risk of premature birth

    6 months

  • Polarimetric biomarkers in population with a high-risk of premature birth

    6 months

  • Parameters polarimetric in population with a high-risk of premature birth

    6 months

Study Arms (2)

Group1: patients with a low risk of premature birth

EXPERIMENTAL

Asymptomatic patient receiving usual follow-up in the maternity ward.

Device: Mueller's polarimetric colposcopy "Group 1"

Group2: patients with a high risk of premature birth

EXPERIMENTAL

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"

Interventions

Mueller's polarimetric colposcopy "Group 2"DEVICE

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.

Group2: patients with a high risk of premature birth
Mueller's polarimetric colposcopy "Group 1"DEVICE

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.

Group1: patients with a low risk of premature birth

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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."

You may not qualify if:

  • 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.
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Bicêtre - Gynecology-Obstetrics Department

Le Kremlin-Bicêtre, France, 94275, France

RECRUITING

MeSH Terms

Conditions

Premature Birth

Condition Hierarchy (Ancestors)

Obstetric Labor, PrematureObstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Study Officials

  • Dominique LUTON, Pr

    Obstetrics gynecology department - Bicetre hospital, Kremlin Bicetre, France

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Dominique LUTON, Pr

CONTACT

01 45 21 77 64dominique.luton@aphp.fr

Angelo PIERANGELO, Dr

CONTACT

01 46 69 43 69angelo.pierangelo@polytechnique.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 23, 2020

First Posted

December 10, 2020

Study Start

December 22, 2020

Primary Completion

April 1, 2026

Study Completion (Estimated)

December 1, 2026

Last Updated

January 21, 2026

Record last verified: 2026-01

Locations

FR(1)