Polarimetric Colposcopy for Cervical Changes in Pregnancy
Mueller Polarimetric Colposcopy for High-performance Detection of Cervical Changes During Pregnancy
Recruiting
N/AInterventional Study
Pregnancy RelatedPremature Birth
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
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Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 and older
Sex
Female
Study type
Interventional
Purpose
Diagnostic
Participants needed
683 (estimated)
Sponsor
Assistance Publique - Hôpitaux de Paris · Other
Who this trial is looking for
This trial is looking for pregnant women to study cervical changes. Participants will undergo a special examination to evaluate the cervix during their pregnancy.
Are You a Good Fit for This Trial?
Rules you outHistory of spontaneous premature laborHistory of late miscarriageHistory of premature rupture of membranes
You may be able to join if
I am an adult.
I have a single pregnancy.
I am at least 20 weeks pregnant.
I have had an ultrasound in my first trimester.
I have given informed consent.
You may not be able to join if
I have known or suspected uterine malformation.
I have premature rupture of membranes.
I have suspicion of chorioamnionitis.
I have abundant bleeding that makes it hard to see my cervix.
I have a history of conization.
I am about to give birth.
I do not have social coverage.
I have limited understanding.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
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 Locations
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Status
Eligibility Criteria
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 p…
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."
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