Cervix Monitor for Detection Conditions Leading to Spontaneous Preterm Delivery

Status unconfirmed

Conditions studied: Preterm Birth

In brief

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.

Key facts

Study ID

NCT04247555

Run by

Advanced Tactile Imaging, Inc.

People needed

270

Starts

2020-01-03

Expected to finish

2022-03-31

Last updated by the study team

2021-07-21

Who can join

Age: any. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

• 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)

Where it is running

• 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

Full record on ClinicalTrials.gov

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