Cervix Monitor for Detection Conditions Leading to Spontaneous Preterm Delivery

Preterm Birth Clinical Trial

— CM  

Official title:

Cervix Monitor for Elasticity and Length Measurements

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT04247555
• Other study ID #: CM02
• Secondary ID: R44HD090793
• Status: Enrolling by invitation
• Start date: January 3, 2020
• Est. completion date: March 31, 2022

Study information

• Verified date: July 2021
• Source: Advanced Tactile Imaging, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 270
• Est. completion date: March 31, 2022
• Est. primary completion date: March 31, 2022
• Gender: Female
• Age group: N/A and older

Eligibility

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)

Related Conditions & MeSH terms

• Premature Birth
• Preterm Birth

Locations

Country	Name	City	State
United States	St. Luke's University Health Network Department of Obstetrics and Gynecology, Division of Maternal Fetal Medicine (MFM)	Bethlehem	Pennsylvania
United States	Rutgers The State University Of New Jersey	New Brunswick	New Jersey

Sponsors (4)

Lead Sponsor	Collaborator
Advanced Tactile Imaging, Inc.	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), Rutgers, The State University of New Jersey, St. Luke's Hospital and Health Network, Pennsylvania

Country where clinical trial is conducted

United States, 

References & Publications (2)

Egorov V, Rosen T, van Raalte H, Kurtenoks V. Cervical Characterization with Tactile-Ultrasound Probe. Open J Obstet Gynecol. 2020 Jan;10(1):85-99. doi: 10.4236/ojog.2020.101008. Epub 2020 Jan 8. — View Citation

Lucente V, van Raalte H, Murphy M, Egorov V. Biomechanical paradigm and interpretation of female pelvic floor conditions before a treatment. Int J Womens Health. 2017 Aug 3;9:521-550. doi: 10.2147/IJWH.S136989. eCollection 2017. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cervix elasticity	Units measurement of elasticity in kPa	During examination procedure
Primary	Cervix Length	Units of measurement of length in mm	During examination procedure