Actively Recruiting

Phase Not Applicable
Age: 18Years +
FEMALE
NCT04661553

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

Led by Assistance Publique - Hôpitaux de Paris · Updated on 2026-01-21

683

Participants Needed

1

Research Sites

310 weeks

Total Duration

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AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Adult female patient
  • Single pregnancy
  • Baseline at 20 or more weeks of amenorrhea for low risk group
  • Baseline at 20 or more and less than 37 weeks of amenorrhea for high risk group
  • Pregnancy dating confirmed by first trimester ultrasound
  • Written and informed consent
  • Low risk group: asymptomatic patient with usual maternity follow-up
  • High risk group: symptomatic patient with cervical changes and cervical length less than 20 mm by ultrasound, or asymptomatic patient with previous premature delivery or late miscarriage and cervical changes with cervical length less than 20 mm
Not Eligible

You will not qualify if you...

  • Known or suspected uterine malformation
  • Multiple pregnancy
  • Premature rupture of membranes
  • Suspicion of chorioamnionitis
  • Heavy active bleeding preventing cervix visualization
  • History of conization
  • Imminent childbirth
  • Medical indications for birth before 37 weeks (severe pre-eclampsia, severe fetal growth restriction, hemorrhagic placenta previa, fetal malformations, etc.)
  • Inability to examine cervix under speculum
  • Lack of social coverage
  • Limited understanding
  • Participation in another interventional research
  • Low risk group exclusion: history of spontaneous premature labor, late miscarriage, or premature rupture of membranes

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Hospital Bicêtre - Gynecology-Obstetrics Department

Le Kremlin-Bicêtre, France, France, 94275

Actively Recruiting

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Research Team

D

Dominique LUTON, Pr

CONTACT

A

Angelo PIERANGELO, Dr

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

PARALLEL

Primary Purpose

DIAGNOSTIC

Number of Arms

2

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