NCT03199079

Brief Summary

Preterm birth is a leading global cause of neonatal mortality despite of numerous advances and intensive research in perinatal medicine. Almost one million children die each year due to complications of preterm birth and in almost all countries with reliable data, preterm birth rates are increasing. Of the 14 million survivors per year, many face a lifetime of disability, including learning disabilities, visual and hearing impairments. Spontaneous preterm delivery (SPTD) is often multi factorial event, precocious cervical softening, shortening and dilatation are a common denominator. The majority of preterm births happen spontaneously, though some are due to early induction of labor or cesarean birth, typically due to medical maternal of neonatal conditions.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started May 2017

Longer than P75 for all trials

Geographic Reach
1 country

2 active sites

Status
completed

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

May 1, 2017

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

May 22, 2017

Completed
1 month until next milestone

First Posted

Study publicly available on registry

June 26, 2017

Completed
2.8 years until next milestone

Results Posted

Study results publicly available

April 14, 2020

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 27, 2022

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 11, 2022

Completed
Last Updated

October 17, 2022

Status Verified

April 1, 2020

Enrollment Period

5 years

First QC Date

May 22, 2017

Results QC Date

January 30, 2020

Last Update Submit

October 11, 2022

Conditions

Preterm Birth

Outcome Measures

Primary Outcomes (1)

  • Cervix Elasticity

    Young's modulus of the cervix at 4 locations. Units of measurement is kPa.

    During examination procedure

Secondary Outcomes (1)

  • Cervix Length

    During examination procedure

Study Arms (2)

Group 1: Non-pregnant women

Non-pregnant women with normal pelvic floor

Other: Measurement

Group 2: Pregnant women

Pregnant women; 22-29 weeks of pregnancy

Other: Measurement

Interventions

MeasurementOTHER

Measurement of cervix elasticity and length measurements is not an intervention

Group 1: Non-pregnant womenGroup 2: Pregnant women

Eligibility Criteria

Age21 Years - 44 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsAdult women
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Conditions precluding patients from participation are listed in the study exclusion criteria below. In addition, cognitively impaired patients will not be asked to participate. No patients will be excluded on the basis of race.

You may qualify if:

  • Adult women age 21-44 years
  • Non-pregnant women, or
  • Pregnant women

You may not qualify if:

  • Active cancer of the colon, rectum wall, cervix, vaginal, uterus or bladder
  • Ongoing or prior radiation therapy for abdominal or pelvic cancer
  • Recent (less than four months) pelvic surgery
  • Surgically absent uterus, rectum or bladder
  • Significant circulatory or cardiac conditions that could cause excessive risk from the examination as determined by attending physician
  • Severe abdominal or pelvic adhesions preventing access to pertinent anatomy
  • Known or suspected bleeding disorder
  • HIV or hepatitis B positive serology
  • Warty lesions on the vulva
  • Extensive varicose veins on the vulva
  • Active skin infection or ulceration within the vagina/vulva (Herpes infection)
  • Presence of a vaginal septum
  • Severe hemorrhoids

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Rutgers Robert Wood Johnson Medical School

New Brunswick, New Jersey, 08854, United States

Location

Princeton Urogynecology

Princeton, New Jersey, 08540, United States

Location

Related Publications (1)

  • 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: 32133244RESULT

MeSH Terms

Conditions

Premature Birth

Interventions

Weights and Measures

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Investigative Techniques

Results Point of Contact

Title
Egorov Vladimir, Principal Investigator
Organization
Advanced Tactile Imaging, Inc.
egorov@tactile-imaging.com
609 883-0100

Study Officials

  • Vladimir Egorov, PhD

    Advanced Tactile Imaging, Inc.

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

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

Study Record Dates

First Submitted

May 22, 2017

First Posted

June 26, 2017

Study Start

May 1, 2017

Primary Completion

April 27, 2022

Study Completion

October 11, 2022

Last Updated

October 17, 2022

Results First Posted

April 14, 2020

Record last verified: 2020-04

Data Sharing

IPD Sharing
Will not share

Locations

US(2)