Elm Tree Medical Inc. — Department of Health and Human Services STTR Phase I: NICHD

Description

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