Measurement of cervical dilation during late pregnancy and labor informs decisions in the management of labor and delivery. Prior published research suggests that practitioners are only 19 to 56% accurate when judging cervical simulators. When measuring laboring women, two practitioners' measurements agree only 49% of the time. Dr. Eva Martin of Elm Tree Medical Inc. developed a novel device, DilaCheck?, to enable practitioners to increase accuracy in cervical dilation measurements. Increased precision in cervical dilation measurements will enable providers to make better recommendations for admission to the hospital, augmentation or induction of labor, and cesarean section. The sterile device is composed of a nitrile glove with a soft, sliding measuring tape attached to the fingers. Elm Tree Medical completed a preliminary trial using a simulator, mirroring prior studies. Fifty Labor and Delivery practitioners completed examinations using standard methods and then the device. Standard methods yielded an accuracy of 46%. With the device, accuracy increased to 96%, representing a 108% increase. The device was equally accurate regardless of years of experience or level of training. Standard methods resulted in a 10.5% rate of errors of two or greater centimeters from the true value. The device eliminated readings that were incorrect by more than one centimeter. DilaCheck? is currently awaiting FDA clearance as a Class I device, following extensive successful biocompatibility, sterility, and manufacturing validation testing. The proposed trial tests the novel DilaCheck? device in vivo. The target population is women admitted to the Labor and Delivery unit for management of the first stage of labor. Dr. Martin will teach physicians working on the Labor and Delivery unit how to use DilaCheck?. After informed consent, the trial coordinator randomizes each patient participant to receive either two cervical dilation examinations with standard methods or two cervical dilation examinations using the device. Two practitioners complete the cervical examinations separately, same as in the prior published in vivo trial assessing dilation measurement precision. The primary outcome is inter-examiner agreement between the two examinations. Secondary outcomes include pain, patient and provider satisfaction, and documentation of adverse events. Planned enrollment is 50 participants over six months. We hypothesize that the device will increase agreement between the two practitioners from about 49% to 96%, as demonstrated in the preliminary simulator trial. The long-term objective is to validate DilaCheck? for 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.
Project Terms: Admission activity; Adverse event; Agreement; arm; biomaterial compatibility; Cervical; Cesarean section; Clinic; Clinical; commercial application; commercialization; Decision Making; Devices; Discipline of obstetrics; Documentation; Educational Status; Enrollment; experience; Fingers; First Labor Stage; flexibility; Goals; Hospitals; improved; in vivo; Individual; Induced Labor; Informed Consent; innovation; Intervention; journal article; Labor augmentation; Late pregnancy; Legal patent; Marketing; Measurement; Measures; Medical; member; Methods; Newborn Infant; Nitriles; novel; Outpatients; Pain; pain score; Participant; Patients; phase 1 study; phase 1 testing; phase I trial; Physicians; pregnant; Pregnant Women; primary outcome; Provider; Publications; Publishing; Quality of Care; Randomized; Randomized Controlled Trials; Reading; Recommendation; Research; Risk; Safety; Sales; satisfaction; secondary outcome; Slide; Sterility; Target Populations; Testing; Time; tool; Tube; two-arm study; Ulmus; Validation; Woman;
