Preterm Birth
Conditions
Brief summary
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.
Detailed description
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.
Interventions
None listed
Sponsors
Rutgers, The State University of New Jersey
St. Luke's Hospital and Health Network, Pennsylvania
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Advanced Tactile Imaging, Inc.
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Inclusion criteria
* Gestational age from 24 to 28 weeks at time of Cervix Monitor measurement * Singleton in the current pregnancy
Exclusion criteria
* 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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cervix elasticity | During examination procedure | Units measurement of elasticity in kPa |
| Cervix Length | During examination procedure | Units of measurement of length in mm |
Countries
United States
Outcome results
None listed