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Inter-examiner Agreement of a Novel Device for the Measurement of Cervical Dilation in Labor: A Randomized Controlled Trial

Award Information
Agency: Department of Health and Human Services
Branch: National Institutes of Health
Contract: 1R41HD094398-01
Agency Tracking Number: R41HD094398
Amount: $168,683.00
Phase: Phase I
Program: STTR
Solicitation Topic Code: NICHD
Solicitation Number: PA16-303
Timeline
Solicitation Year: 2016
Award Year: 2018
Award Start Date (Proposal Award Date): 2018-09-21
Award End Date (Contract End Date): 2020-06-30
Small Business Information
3350 VICENTE ST
San Francisco, CA 94116-2661
United States
DUNS: 080070588
HUBZone Owned: No
Woman Owned: Yes
Socially and Economically Disadvantaged: No
Principal Investigator
 VINCENZO BERGHELLA
 (215) 955-9191
 vincenzo.berghella@jefferson.edu
Business Contact
 EVA MARTIN
Phone: (215) 805-0862
Email: evamartin@elmtreemedical.com
Research Institution
 THOMAS JEFFERSON UNIVERSITY
 
125 S 9TH STREET
PHILADELPHIA, PA 19107-5125
United States

 Nonprofit college or university
Abstract

Measurement of cervical dilation during late pregnancy and labor informs decisions in the management of
labor and deliveryPrior published research suggests that practitioners are onlytoaccurate when
judging cervical simulatorsWhen measuring laboring womentwo practitionersandaposmeasurements agree
onlyof the timeDrEva Martin of Elm Tree Medical Incdeveloped a novel deviceDilaCheckto
enable practitioners to increase accuracy in cervical dilation measurementsIncreased precision in cervical dilation measurements will enable providers to make better recommendations for admission to the hospitalaugmentation or induction of laborand cesarean sectionThe sterile device is composed of a nitrile glove with a softsliding measuring tape attached to the fingersElm Tree Medical completed a preliminary trial using a simulatormirroring prior studiesFifty Labor and Delivery practitioners completed examinations using standard methods and then the deviceStandard methods yielded an accuracy ofWith the deviceaccuracy increased torepresenting aincreaseThe device was equally accurate regardless of years of experience or level of trainingStandard methods resulted in arate of errors of two or greater centimeters from the true valueThe device eliminated readings that were incorrect by more than one centimeterDilaCheckis currently awaiting FDA clearance as a Class I devicefollowing extensive successful biocompatibilitysterilityand manufacturing validation testingThe proposed trial tests the novel DilaCheckdevice in vivoThe target population is women admitted to
the Labor and Delivery unit for management of the first stage of laborDrMartin will teach physicians
working on the Labor and Delivery unit how to use DilaCheckAfter informed consentthe trial
coordinator randomizes each patient participant to receive either two cervical dilation examinations with
standard methods or two cervical dilation examinations using the deviceTwo practitioners complete the
cervical examinations separatelysame as in the prior published in vivo trial assessing dilation
measurement precisionThe primary outcome is inter examiner agreement between the two
examinationsSecondary outcomes include painpatient and provider satisfactionand documentation of
adverse eventsPlanned enrollment isparticipants over six monthsWe hypothesize that the device will increase agreement between the two practitioners from abouttoas demonstrated in the
preliminary simulator trialThe long term objective is to validate DilaCheckfor in vivo use in increasing
precision in cervical dilation measurements so that this tool may be available to Labor and Delivery
providers to enhance quality of care for pregnant mothers Labor and Delivery providers use cervical dilation measurements to manage laborbut standard methods of measurement are only aboutaccurateWithmillion deliveries in the US a year and overcesarean sections performed for arrest of dilationmillions of women and newborns in the US alone stand to benefit from increased accuracy in cervical dilation measurementsPotential benefits include increased agreement in dilation measurements between hospital team members and better recommendations regarding admission to the hospitalaugmentation of laborinduction of laborand cesarean section

* Information listed above is at the time of submission. *

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