Feasibility Study and Predictive Value of the Uterine Cervix Polarimetric Imaging for the Management of the Threat of Premature Delivery.

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02859298
• Date of registration: 04/08/2016
• Prospective Registration: Yes
• Primary sponsor: Brugmann University Hospital
• Public title: Feasibility Study and Predictive Value of the Uterine Cervix Polarimetric Imaging for the Management of the Threat of Premature Delivery.
• Scientific title: Feasibility Study and Predictive Value of the Uterine Cervix Polarimetric Imaging for the Management of the Threat of Premature Delivery : The POLARMAP Project
• Date of first enrolment: August 9, 2016
• Target sample size: 0
• Recruitment status: Withdrawn
• URL: https://clinicaltrials.gov/show/NCT02859298
• Study type: Interventional
• Study design: Allocation: Non-Randomized. Intervention model: Parallel Assignment. Primary purpose: Diagnostic. Masking: None (Open Label).
• Phase: N/A

Countries of recruitment

Belgium

Contacts

• Name: André Nazac, MD
• Affiliation: CHU Brugmann

Key inclusion & exclusion criteria

Inclusion Criteria:

- Age = 18 years

- normal pregnancy for control group

- threat of premature delivery after 24 weeks of pregnancy for test group

Exclusion Criteria:

- None



Age minimum: 18 Years
Age maximum: N/A
Gender: Female

Health Condition(s) or Problem(s) studied

Premature Delivery

Intervention(s)

Device: Uterine Cervix Polarimetric Imaging

Primary Outcome(s)

Signal to noise ratio [Time Frame: 1 second]

Lickert scale [Time Frame: 10 minutes]

Reproducibility (%) [Time Frame: 1 second]

Secondary Outcome(s)

Depolarization [Time Frame: 1 second]

Retardance [Time Frame: 1 second]

Secondary ID(s)

CHUB-Polarmap

Source(s) of Monetary Support

Please refer to primary and secondary sponsors