Feasibility Study and Predictive Value of the Uterine Cervix Polarimetric Imaging for the Management of the Threat of Premature Delivery : The POLARMAP Project
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- Reproducibility (%)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Age ≥ 18 years
- •normal pregnancy for control group
- •threat of premature delivery after 24 weeks of pregnancy for test group
排除标准
- 未提供
结局指标
主要结局
Reproducibility (%)
时间窗: 1 second
Reproducibility of acquired images (expressed in %)
Lickert scale
时间窗: 10 minutes
Measure of the acceptability of the patient (psychometric scale to be filled by the patient)
Signal to noise ratio
时间窗: 1 second
Measure of polarimetric imaging feasibility. Signal to noise ratio in a measurement time compatible with in vivo imaging (less than one second)
次要结局
- Retardance(1 second)
- Depolarization(1 second)
研究者
Andre Nazac
Head of clinic
Brugmann University Hospital
