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临床试验/NCT04247555
NCT04247555Unknown不适用

Cervix Monitor for Elasticity and Length Measurements

Advanced Tactile Imaging, Inc.2 个研究点 分布在 1 个国家目标入组 270 人开始时间: 2020年1月3日最近更新:
适应症

试验速览

阶段
不适用
入组人数
270
试验地点
2
主要终点
Cervix elasticity

研究概览

简要总结

Preterm birth is a leading cause of neonatal mortality despite of numerous advances and intensive research in perinatal medicine. Almost one million children die every year due to the complications of preterm birth and rates are on the rise. Of the 14 million survivors per year, most face a lifetime of disability, including learning disabilities, visual and hearing impairments. The majority of preterm birth happen spontaneously (SPTD) which is often a multi factorial event, precocious cervical softening, shortening and dilatation are a common underlying factor. In the scope of this project the investigators propose to develop and clinically validate a new device, Cervix Monitor (CM), for detecting cervix conditions leading to SPTD and its risk assessment.

详细描述

SPTD is closely related to a premature cervical ripening. The scientific basis for the proposed project is that the elasticity modulus of a cervix is a more sensitive parameter characterizing the stage of cervical ripening. The main component of the cervical tissue is collagen. Cervical ripening is the result of realignment of collagen, degradation of collagen cross-linking due to proteolytic enzymes. These processes affect the elasticity modulus of the cervical tissue. Therefore, assessment of cervix by a device (CM) measuring cervical elasticity (stiffness) and cervical length (effacement) appears to be an adequate approach for identifying pregnant women at high risk of SPTD. The CM is based on measuring applied pressure to the cervix by a tactile sensor array (stress data) and ultrasound measurement of cervix length (strain data). Tactile and ultrasound sensors are allocated on the tip of the measuring part of vaginal probe. The discovery of novel bio markers that could reliably identify women who will subsequently deliver preterm, may allow for timely medical intervention and targeted therapeutic treatments aimed at improving maternal and fetal outcomes.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

性别
Female
接受健康志愿者

入选标准

  • Gestational age from 24 to 28 weeks at time of Cervix Monitor measurement
  • Singleton in the current pregnancy

排除标准

  • Fatal anomaly
  • History of fetal reduction in the current pregnancy to the singleton gestation
  • Preterm rapture of membranes
  • Current or planned cervical cerclage
  • Planned indicated preterm delivery
  • Active known cancer of the colon, rectum wall, cervix, vaginal, uterus or bladder
  • Ischemic heart disease and or arrhythmia
  • Active skin infection or ulceration within the vaginal/vulva (Herpes infection)

结局指标

主要结局

Cervix elasticity

时间窗: During examination procedure

Units measurement of elasticity in kPa

Cervix Length

时间窗: During examination procedure

Units of measurement of length in mm

次要结局

未报告次要终点

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (2)

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