NCT04247555

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
270

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2020

Typical duration for all trials

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 3, 2020

Completed
25 days until next milestone

First Submitted

Initial submission to the registry

January 28, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 30, 2020

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2022

Completed
Last Updated

July 21, 2021

Status Verified

July 1, 2021

Enrollment Period

2.2 years

First QC Date

January 28, 2020

Last Update Submit

July 20, 2021

Conditions

Preterm Birth

Outcome Measures

Primary Outcomes (2)

  • Cervix elasticity

    Units measurement of elasticity in kPa

    During examination procedure

  • Cervix Length

    Units of measurement of length in mm

    During examination procedure

Eligibility Criteria

Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsPregnant women with gestational age from 24 to 28 weeks.
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Woman at 24 to 28 weeks of pregnancy scheduled for a regular examination at the Divisions of Maternal Fetal Medicine will be considered eligible for this study enrollment.

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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Rutgers The State University Of New Jersey

New Brunswick, New Jersey, 08854, United States

Location

St. Luke's University Health Network Department of Obstetrics and Gynecology, Division of Maternal Fetal Medicine (MFM)

Bethlehem, Pennsylvania, 18015, United States

Location

Related 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.

    PMID: 32133244BACKGROUND

  • 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.

    PMID: 28831274BACKGROUND

MeSH Terms

Conditions

Premature Birth

Condition Hierarchy (Ancestors)

Obstetric Labor, PrematureObstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Study Officials

  • Vladimir Egorov, PhD

    Advanced Tactile Imaging, Inc.

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 28, 2020

First Posted

January 30, 2020

Study Start

January 3, 2020

Primary Completion

March 31, 2022

Study Completion

March 31, 2022

Last Updated

July 21, 2021

Record last verified: 2021-07

Data Sharing

IPD Sharing
Will not share

Locations

US(2)