Premature Delivery Clinical Trial
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
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.
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.
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