Status:
UNKNOWN
Mueller Polarimetric Colposcopy for High-performance Detection of Cervical Changes During Pregnancy
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Conditions:
Pregnancy Related
Premature Birth
Eligibility:
FEMALE
18+ years
Phase:
NA
Brief 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...
Detailed Description
Interventional research protocol involving the human person relating to a medical device. This is a prospective, not randomized, monocentric study. Prematurity accounts for around 11% of births worldw...
Eligibility Criteria
Inclusion
- Major patient.
- Single pregnancy.
- Baseline ≥ 20 amenorrhea week and \<37 amenorrhea week.
- 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
- 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."
Key Trial Info
Start Date :
December 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2024
Estimated Enrollment :
683 Patients enrolled
Trial Details
Trial ID
NCT04661553
Start Date
December 1 2020
End Date
May 1 2024
Last Update
December 10 2020
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