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NCT03199079

Cervix Monitor for Elasticity and Length Measurements

Completed Results posted Last updated 17 October 2022
What this trial tests

trial testing Measurement in Preterm Birth in 20 participants. Completed in 11 October 2022.

Timeline
1 May 2017
Primary endpoint
27 April 2022
11 October 2022

Quick facts

Lead sponsorAdvanced Tactile Imaging, Inc.
StatusCompleted
Study typeOBSERVATIONAL
Enrollment20
Start date1 May 2017
Primary completion27 April 2022
Estimated completion11 October 2022
Sites2 locations across United States

Drugs / interventions tested

Conditions studied

Sponsor

Advanced Tactile Imaging, Inc.

Who can join

Adults 21 to 44, female only, with Preterm Birth. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Cervix Elasticity Primary · During examination procedure

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

GroupValue95% CI
Non-pregnant Women54± 17
Pregnant Women19.7± 15.4
Cervix Length Secondary · During examination procedure

Cervix length in mm

GroupValue95% CI
Non-pregnant Women42± 13
Pregnant Women30.7± 6.6

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

Other trials of Measurement

Trials testing the same drug.

Other recruiting trials for Preterm Birth

Currently open trials in the same condition.

Other Advanced Tactile Imaging, Inc. trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03199079.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing