Mueller Polarimetric Colposcopy for High-performance Detection of Cervical Changes During Pregnancy
Mueller Polarimetric Colposcopy for High-performance Detection of Cervical Changes During Pregnancy (COLPOTERME)
Assistance Publique - Hôpitaux de Paris
683 participants
Dec 22, 2020
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria9
- 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 Criteria16
- 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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Interventions
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.
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.
Locations(1)
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NCT04661553