Mueller polarimetric colposcopy to detect cervical changes during pregnancy.

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

This project will try a special Mueller polarimetric colposcopy scan during pregnancy to see if it can predict when a person will give birth and help screen for risk of preterm birth.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 683 (estimated)
• Ages: 18 Years and up
• Sex: Female
• Sponsor: Assistance Publique - Hôpitaux de Paris (Academic / other)
• Locations: 1 site (Le Kremlin-Bicêtre, France)
• Trial ID: NCT04661553 on ClinicalTrials.gov

What this trial studies

This is a prospective, single-center interventional study using a Mueller polarimetric colposcope to image cervical microstructure changes during pregnancy. Participants are enrolled into two groups: low-risk pregnant people and high-risk pregnant people with documented cervical shortening (<20 mm). Researchers will extract polarimetric parameters and derive a combined "Polarimetric Score" intended to reflect cervical remodeling and correlate with gestational age and delivery timing. The goal is to identify the best polarimetric biomarkers and test whether the score can predict term of childbirth and serve as a screening tool for prematurity.

Who should consider this trial

Good fit: Adults with a single pregnancy dated by first-trimester ultrasound and baseline ≥20 weeks who either have routine antenatal follow-up (low risk) or symptomatic/high-risk features with cervical length <20 mm and gestational age <37 weeks (high risk) and can give informed consent.

Not a fit: People with uterine malformations, multiple pregnancy, premature rupture of membranes, suspected chorioamnionitis, heavy active cervical bleeding, history of conization, or imminently impending birth are excluded and unlikely to benefit from this procedure.

Why it matters

Potential benefit: If successful, this technique could allow earlier and more accurate prediction of preterm birth risk, enabling targeted monitoring or interventions to reduce neonatal complications.

How similar studies have performed: Mueller polarimetric imaging is a relatively new application for the cervix; prior work shows correlations between polarimetric parameters and gestational age, but using it to predict preterm birth remains novel and unproven.

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 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."

Where this trial is running

Le Kremlin-Bicêtre, France

• Hospital Bicêtre - Gynecology-Obstetrics Department — Le Kremlin-Bicêtre, France, France (Recruiting)

Study contacts

• Principal investigator: Dominique LUTON, Pr — Obstetrics gynecology department - Bicetre hospital, Kremlin Bicetre, France
• Study coordinator: Dominique LUTON, Pr

Conditions Pregnancy Related; Premature Birth