NCT04661553 Mueller Polarimetric Colposcopy for High-performance Detection of Cervical Changes During Pregnancy
| NCT ID | NCT04661553 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Assistance Publique - Hôpitaux de Paris |
| Condition | Pregnancy Related |
| Study Type | INTERVENTIONAL |
| Enrollment | 683 participants |
| Start Date | 2020-12-22 |
| Primary Completion | 2026-04 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 683 participants in total. It began in 2020-12-22 with a primary completion date of 2026-04.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 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 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."
Contact & Investigator
Dominique LUTON, Pr
PRINCIPAL INVESTIGATOR
Obstetrics gynecology department - Bicetre hospital, Kremlin Bicetre, France
Frequently Asked Questions
Who can join the NCT04661553 clinical trial?
This trial is open to female participants only, aged 18 Years or older, studying Pregnancy Related. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04661553 currently recruiting?
Yes, NCT04661553 is actively recruiting participants. Contact the research team at dominique.luton@aphp.fr for enrollment information.
Where is the NCT04661553 trial being conducted?
This trial is being conducted at Le Kremlin-Bicêtre, France.
Who is sponsoring the NCT04661553 clinical trial?
NCT04661553 is sponsored by Assistance Publique - Hôpitaux de Paris. The principal investigator is Dominique LUTON, Pr at Obstetrics gynecology department - Bicetre hospital, Kremlin Bicetre, France. The trial plans to enroll 683 participants.