Mueller polarimetric colposcopy to detect cervical changes during pregnancy.

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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
• Email: dominique.luton@aphp.fr
• Phone: 01 45 21 77 64

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Prenatal education to reduce environmental exposures during pregnancy

  Aimed at pregnant people, this program tests whether a classroom-style education can help reduce exposure to harmful pollutants from seafood and nearby pollution sources.

  Recruiting at 2 sites The University of Texas Medical Branch, Galveston · Galveston, Texas and 1 other locations · NCT07758114

• Wireless MicroPremVitals Button Sensor for the NICU

  This study tests a tiny wireless sensor system to monitor heart rate, oxygen, and temperature in extremely preterm babies in the NICU to see if it works safely without wires.

  Recruiting McGill University Health Centre/Research Institute of the McGill University Health Centre · Montreal, Quebec · NCT07732257

• Interprofessional Training to Improve Care for Peri-Delivery Patients with Substance Use Disorder

  This program tests INSPIRE, a set of online and in-person trainings for healthcare teams to reduce stigma and improve care for people with substance use disorder around labor, delivery, and postpartum at the University of Utah.

  Recruiting University of Utah · Salt Lake City, Utah · NCT07707115

• Lower-extremity blood pressure monitoring during cesarean under spinal anesthesia

  This study tests whether noninvasive blood pressure monitoring from the toe is better than the arm at predicting neonatal outcomes during cesarean delivery with spinal anesthesia.

  Recruiting Ohio State University · Columbus, Ohio · NCT07685730

• Care4mommies: a compassion-based approach to support moms-to-be

  A compassion-based program with pregnancy-specific content is being tested to see if it helps pregnant people build self-compassion and strengthen the bond with their baby.

  Recruiting Portucalense University · Porto, Porto District · NCT07611175

• Eating more eggs during pregnancy to support fetal brain development

  This test will see if pregnant women who eat 10–14 eggs per week have better fetal brain development than those who follow a general healthy prenatal diet.

  Recruiting University of Kansas Medical Center · Kansas City, Kansas · NCT07583186

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.