Feasibility Study and Predictive Value of the Uterine Cervix Polarimetric Imaging for the Management of the Threat of Premature Delivery.
Primary Purpose
Premature Delivery
Status
Withdrawn
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Uterine Cervix Polarimetric Imaging
Sponsored by

About this trial
This is an interventional diagnostic trial for Premature Delivery focused on measuring Premature Delivery, Polarimetric Imaging, Polarimetric colposcope, Diagnostic tool
Eligibility 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
Sites / Locations
- CHU Brugmann
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Suspicion of threat of premature delivery
Normal pregnancy
Arm Description
10 consecutive patients arriving at the Brugmann maternity with suspicion of a threat of premature delivery will be encouraged to participate in this study, before the onset of any tocolytic treatment. The patient will receive an standard examination of the cervix and at the same time a polarimetric measurement.
10 control patients, with the same term of pregnancy, will be benefit from the same measurements.
Outcomes
Primary Outcome Measures
Signal to noise ratio
Measure of polarimetric imaging feasibility. Signal to noise ratio in a measurement time compatible with in vivo imaging (less than one second)
Reproducibility (%)
Reproducibility of acquired images (expressed in %)
Lickert scale
Measure of the acceptability of the patient (psychometric scale to be filled by the patient)
Secondary Outcome Measures
Retardance
Correlation between retardance (polarimetric parameter) and premature delivery.
Depolarization
Correlation between depolarization (polarimetric parameter) and premature delivery.
Full Information
NCT ID
NCT02859298
First Posted
August 4, 2016
Last Updated
August 6, 2020
Sponsor
Brugmann University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT02859298
Brief Title
Feasibility Study and Predictive Value of the Uterine Cervix Polarimetric Imaging for the Management of the Threat of Premature Delivery.
Official Title
Feasibility Study and Predictive Value of the Uterine Cervix Polarimetric Imaging for the Management of the Threat of Premature Delivery : The POLARMAP Project
Study Type
Interventional
2. Study Status
Record Verification Date
August 2020
Overall Recruitment Status
Withdrawn
Why Stopped
Lack of human ressources
Study Start Date
August 9, 2016 (Actual)
Primary Completion Date
August 24, 2018 (Actual)
Study Completion Date
August 24, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Brugmann University Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Prematurity is the first cause of perinatal mortality and morbidity worldwide. The threat of premature delivery (TPD), the most important complication and the leading cause of hospitalization during pregnancy has multiple origins which are seldom precisely identified.
The standard medical examination for the detection of patients with TPD is the endovaginal ultrasonographic examination of uterine cervix (echography).
Gynaecologists focus on the use of a new low-cost diagnostic tool based on optical imaging technologies with polarized light. The polarization is the spatio-temporal orientation of a wave's electric field. This light property, invisible with the naked eye, is sensitive to the morphological transformations of a tissue and the orientation of collagen fibers. Such tool would not require an extensive training and should provide an objective quantitative result with a sensitivity and specificity greater than conventional ultrasonography. This would be a considerable contribution to the health care of TPD, a real societal problem in Belgium, Europe and all over the world.
The POLARMAP project proposes the possibility to observe in vivo and during pregnancy, the structural evolution, the density and the orientation changes of collagen fibers. A relevant scoring of collagen status might provide an alternative, and potentially objective and accurate quantifier of the time left before delivery.
Detailed Description
Prematurity is the first cause of perinatal mortality and morbidity worldwide. The threat of premature delivery (TPD), the most important complication and the leading cause of hospitalization during pregnancy has multiple origins which are seldom precisely identified.
In Belgium and Europe, the estimated rate of premature births is about 10 %. This rate has been stable over the last two decades in spite of the introduction of new tocolytic treatments and the use of cervical length measurement by transvaginal ultrasound to assess the risk of preterm birth.
The standard medical examination for the detection of patients with TPD is the endovaginal ultrasonographic examination of uterine cervix (echography). Ultrasound examination is more accurate and reproducible compared to cervical digital one, and it possesses two essential qualities of a diagnostic examination: it is easily accepted by the patients and the learning curve is fast.
This technique is validated with well-known criteria, namely, the shortening of the effective length and the opening of the internal orifice of the cervix. The threshold for these two criteria depends on the practitioner's choice: at 30 mm effective length, the sensitivity and negative predictive values are high, but the specificity is poor, while the opposite is true if the threshold is set at 20 mm.
Ultrasound examination for the identification of the patients at risk of premature delivery is a real improvement over cervical digital examination. However, this technique is not ideal, due to the lack of objective criteria for the choice of threshold, because of the imperfect correlation ("noise") between the measured effective length of uterine cervix and the time left before the birth. Moreover, the use of cervical ultrasonography in the strategy of premature delivery screening is not well established.Finally, the transvaginal ultrasound probes are not available in all perinatal centers that would be yet all concerned in case of preterm delivery.
Gynaecologists focus on the use of a new low-cost diagnostic tool based on optical imaging technologies with polarized light. The polarization is the spatio-temporal orientation of a wave's electric field. This light property, invisible with the naked eye, is sensitive to the morphological transformations of a tissue and the orientation of collagen fibers. Such tool would not require an extensive training and should provide an objective quantitative result with a sensitivity and specificity greater than conventional ultrasonography. This would be a considerable contribution to the health care of TPD, a real societal problem in Belgium, Europe and all over the world.
The POLARMAP project proposes the possibility to observe in vivo and during pregnancy, the structural evolution, the density and the orientation changes of collagen fibers.
During the whole pregnancy and until its very end, the cervix is kept closed by abundant and well-organized collagen (the main structural protein in cervical tissue), when the collagen is partly destroyed and/or disorganized before the onset of labor. These changes in collagen structure, which soften the cervix and allow its opening for child birth, have been seen for both premature and full-term births. A relevant scoring of collagen status might thus provide an alternative, and potentially objective and accurate quantifier of the time left before delivery.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Premature Delivery
Keywords
Premature Delivery, Polarimetric Imaging, Polarimetric colposcope, Diagnostic tool
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Suspicion of threat of premature delivery
Arm Type
Experimental
Arm Description
10 consecutive patients arriving at the Brugmann maternity with suspicion of a threat of premature delivery will be encouraged to participate in this study, before the onset of any tocolytic treatment. The patient will receive an standard examination of the cervix and at the same time a polarimetric measurement.
Arm Title
Normal pregnancy
Arm Type
Active Comparator
Arm Description
10 control patients, with the same term of pregnancy, will be benefit from the same measurements.
Intervention Type
Device
Intervention Name(s)
Uterine Cervix Polarimetric Imaging
Intervention Description
Polarimetric imaging is a promising optical technique that can provide information in large field and potentially in vivo about the abundance and 3D structure of collagen. Images will be taken with a polarimetric colposcope. As the imaging is realized with visible light from classical sources (lamps or LEDs, neither lasers or other high intensity sources, nor any ionizing UV radiation) and without any chemicals, it is totally innocuous, just like the intensity imaging used in conventional colposcopy.
Primary Outcome Measure Information:
Title
Signal to noise ratio
Description
Measure of polarimetric imaging feasibility. Signal to noise ratio in a measurement time compatible with in vivo imaging (less than one second)
Time Frame
1 second
Title
Reproducibility (%)
Description
Reproducibility of acquired images (expressed in %)
Time Frame
1 second
Title
Lickert scale
Description
Measure of the acceptability of the patient (psychometric scale to be filled by the patient)
Time Frame
10 minutes
Secondary Outcome Measure Information:
Title
Retardance
Description
Correlation between retardance (polarimetric parameter) and premature delivery.
Time Frame
1 second
Title
Depolarization
Description
Correlation between depolarization (polarimetric parameter) and premature delivery.
Time Frame
1 second
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
André Nazac, MD
Organizational Affiliation
CHU Brugmann
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU Brugmann
City
Brussels
ZIP/Postal Code
1020
Country
Belgium
12. IPD Sharing Statement
Citations:
PubMed Identifier
23787602
Citation
Pierangelo A, Nazac A, Benali A, Validire P, Cohen H, Novikova T, Ibrahim BH, Manhas S, Fallet C, Antonelli MR, Martino AD. Polarimetric imaging of uterine cervix: a case study. Opt Express. 2013 Jun 17;21(12):14120-30. doi: 10.1364/OE.21.014120.
Results Reference
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PubMed Identifier
27108592
Citation
Rehbinder J, Haddad H, Deby S, Teig B, Nazac A, Novikova T, Pierangelo A, Moreau F. Ex vivo Mueller polarimetric imaging of the uterine cervix: a first statistical evaluation. J Biomed Opt. 2016 Jul 1;21(7):71113. doi: 10.1117/1.JBO.21.7.071113.
Results Reference
background
PubMed Identifier
25321725
Citation
Bancelin S, Nazac A, Ibrahim BH, Dokladal P, Decenciere E, Teig B, Haddad H, Fernandez H, Schanne-Klein MC, De Martino A. Determination of collagen fiber orientation in histological slides using Mueller microscopy and validation by second harmonic generation imaging. Opt Express. 2014 Sep 22;22(19):22561-74. doi: 10.1364/OE.22.022561.
Results Reference
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Feasibility Study and Predictive Value of the Uterine Cervix Polarimetric Imaging for the Management of the Threat of Premature Delivery.
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