Cervix Monitor for Detection Conditions Leading to Spontaneous Preterm Delivery

• Conditions: Preterm Birth

• Registration Number: NCT04247555
• Lead Sponsor: Advanced Tactile Imaging, Inc.

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.

Study Timeline

• Study Start: 2020-01-03
• Study First Submitted: 2020-01-28
• Study First Submitted QC: 2020-01-29
• Study First Posted: 2020-01-30
• Status Verified: 2021-07
• Last Update Submitted: 2021-07-20
• Last Update Posted: 2021-07-21
• Primary Completion: 2022-03-31
• Study Completion: 2022-03-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 270

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)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Cervix elasticity	During examination procedure	Units measurement of elasticity in kPa
Cervix Length	During examination procedure	Units of measurement of length in mm

Trial Locations

Locations (2)

Rutgers The State University Of New Jersey; 🇺🇸 New Brunswick, New Jersey, United States

St. Luke's University Health Network Department of Obstetrics and Gynecology, Division of Maternal Fetal Medicine (MFM); 🇺🇸 Bethlehem, Pennsylvania, United States