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

NCT02859298 | Withdrawn

• 1 other identifier: CHUB-Polarmap
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Premature Delivery

Keywords

Premature Delivery; Polarimetric Imaging; Polarimetric colposcope; Diagnostic tool

Outcome Measures

Primary Outcomes (3)

• 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)

  1 second

• Reproducibility (%)

  Reproducibility of acquired images (expressed in %)

  1 second

• Lickert scale

  Measure of the acceptability of the patient (psychometric scale to be filled by the patient)

  10 minutes

Secondary Outcomes (2)

• Retardance

  1 second

• Depolarization

  1 second

Study Arms (2)

Suspicion of threat of premature delivery

EXPERIMENTAL

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.

Device: Uterine Cervix Polarimetric Imaging

Normal pregnancy

ACTIVE COMPARATOR

10 control patients, with the same term of pregnancy, will be benefit from the same measurements.

Device: Uterine Cervix Polarimetric Imaging

Interventions

Uterine Cervix Polarimetric Imaging DEVICE

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.

Normal pregnancy; Suspicion of threat of premature delivery

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 years
• normal pregnancy for control group
• threat of premature delivery after 24 weeks of pregnancy for test group

You may not qualify if:

• \- None

Sponsors & Collaborators

• Brugmann University Hospital: lead

Study Sites (1)

CHU Brugmann

Brussels, 1020, Belgium

Location

Related Publications (3)

• 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.

  PMID: 23787602 BACKGROUND

• 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.

  PMID: 27108592 BACKGROUND

• 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.

  PMID: 25321725 BACKGROUND

MeSH Terms

Conditions

Premature Birth

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• André Nazac, MD

  CHU Brugmann

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of clinic

Study Record Dates

• First Submitted: August 4, 2016
• First Posted: August 9, 2016
• Study Start: August 9, 2016
• Primary Completion: August 24, 2018
• Study Completion: August 24, 2018
• Last Updated: August 7, 2020

Record last verified: 2020-08

Locations

BE (1)