Fetal Life: Smart-Device Based Uterine Activity Monitoring
Condition: Labor Pain; Contraction
MeSH terms: Labor Pain
Study type: Interventional

Summary: 
      This study will compare the performance of a contraction monitor (tocometer) device developed
      by Fetal Life with standard tocometer devices.

      The study aims to test a uterine contraction monitor that can be applied by the patient to
      her abdomen and connected to her smart device to detect the frequency and duration of uterine
      contractions. Phase 1 will collect data for calibration of the monitor and for a
      noninferiority study comparing the Fetal Life uterine contraction monitor (tocometer) with
      standard tocometry devices. Phase 2 will be a feasibility study in which patients will
      position the monitor, connect to the corresponding Fetal Life app and measure their own
      uterine contraction activity.

      The study's hypothesis is that after calibration, the new monitor will reliably detect at
      least 95% of the number and duration of contractions detected by the standard monitor, and
      that the device will perform comparably whether applied by the patient or by research staff.
    

Detailed description: 
      Pregnant patients are counseled to monitor the frequency and duration of contractions in
      order to know when to come to the hospital for evaluation. Once a pregnant patient arrives at
      the hospital, contraction monitoring is important to help diagnose labor, which is defined as
      contractions with cervical change. In the hospital, a pressure-sensitive external contraction
      monitor or tocometer is positioned on the patient's abdomen with a belt to measure the
      frequency and length of her contractions. These tocometry monitors are impractical for home
      use because of their expense and because they create their output by connecting to bulky
      component devices. For these reasons reason, pregnant patients at home do not have access to
      automated tocometry monitoring.

      Patients are educated during prenatal care that contractions should be timed from the start
      of one contraction to the start of the next. These instructions can be difficult for patients
      to remember, and patients who are having painful contractions may prefer a more automated
      method for timing contractions. All methods currently available for home contraction tracking
      (on paper, using a smart device, or using one of many available smart device applications)
      require manual data entry either by the patient or her support partners.

      Patients are cautioned during pregnancy to maintain awareness of the development of uterine
      contractions. Early in pregnancy, patients are frequently counseled that infrequent,
      irregular contractions can be normal, but that frequent contractions occurring in a pattern
      can be a sign of preterm labor. As dehydration can cause the uterus to contract, preterm
      patients who notice contractions occurring in a pattern are often instructed to drink water,
      observe their contraction pattern, and come to the hospital if their contractions continue to
      occur every 15 minutes or more frequently following oral hydration. At term, patients are
      frequently counseled to come to the hospital when they are experiencing contractions that
      last about a minute, are occurring every five minutes, and have been at this duration and
      frequency for about an hour. Both preterm and at term, patients may have runs of contractions
      which resolve with time and hydration, but patients in both situations need to recognize when
      their contractions have reached the parameters recommended by their health care providers to
      seek medical attention.

      The new tocometer device tested in this study has significant cost savings in comparison to
      existing devices, and connects to a smart phone or tablet rather than a bulky receiver. The
      device will allow the patient to apply a monitor belt, connect it to her smart phone, and
      view a graphical representation of her contraction pattern with verbal descriptors that she
      can share with her health care team. Many patients have at least one visit to the hospital
      for evaluation of a contraction pattern which did not warrant this time and expense. This
      device may help patients to share a more accurate report of their symptoms with their
      prenatal care providers, potentially decreasing the stress of manual contraction tracking,
      improving the understanding of progress in early labor and decreasing unnecessary hospital
      visits. The device and app will not give the patient instructions on whether to come to the
      hospital, but will be used to help the patient understand if her uterine activity meets the
      parameters her prenatal care provider has given her to come in for evaluation. The Fetal Life
      device is constructed of smooth, latex-free plastic, is powered by a Lithium battery similar
      to a watch battery, and is held in place using a standard tocometry belt manufactured by
      General Electric. The investigators consider this to be a nonsignificant risk device.

      Phase 1 of this initial trial will allow a noninferiority comparison of the performance of
      this new contraction monitoring device with standard devices currently used in Labor and
      Delivery settings for monitoring duration and frequency of contractions. Phase 2 will assess
      feasibility for patient use.

      Procedure for Calibration and Noninferiority Phase (Phase 1):

        -  Patients meeting inclusion criteria will be offered participation in the study by the
           Clinical Trials Unit (CTU) Staff

        -  If the patient agrees to participate, CTU staff will obtain consent.

        -  The patient will be assigned a participant number.

        -  The Fetal Life tocometer will be applied to the patient's lower abdomen in addition to
           the standard tocometer used on Labor and Delivery and secured with the monitor belt by
           CTU staff

        -  The Fetal Life tocometer will be paired the study iPad and output will be captured by
           CTU staff

        -  The patient will be asked to cough in order to create a peak that synchronizes the
           graphic output of the Fetal Life tocometer and the standard tocometer

        -  The patient will be monitored with the both the standard tocometer and the Fetal Life
           tocometer for 45-60 minutes

        -  If the maternal or fetal status requires changes of maternal position during the trial,
           the Fetal Life monitor may be left in place, disconnected from the iPad or removed from
           the patient, whichever is least disruptive, so as not to interfere with the patient's
           obstetrical care in any way

        -  CTU staff will document patient's age, parity, estimated gestational age and body mass
           index on a data collection sheet identified by participant number. No personal health
           information will be maintained on the data sheet.

        -  If 45-60 minutes of monitoring is not completed, CTU staff will document the reason why

        -  Patient will complete a brief survey on monitor comfort in comparison to the standard
           monitor

        -  Image files from the standard tocometry fetal monitoring system will be exported for
           comparison with the output of the Fetal Life tocometer.

        -  Fetal Life device will be sanitized with the antiviral, antibacterial wipes used
           routinely for sanitation of the standard tocometer devices before use with another
           patient. A new belt will be attached to the device for each subject.

        -  For calibration, deidentified data from standard tocometer and the Fetal Life device
           will be reviewed by the team in the University of Louisville School of Engineering so
           that any needed adjustments can be made to the pressure transducer's sensitivity or
           graphic output

        -  After calibration is completed (estimate 3 subjects needed), subjects will then be
           enrolled using the same protocol to collect data required for statistical analysis of
           non-inferiority

      Procedure for Feasibility Phase (Phase 2):

        -  Patients meeting the inclusion criteria will be offered participation in the study by
           the Clinical Trials Unit (CTU) Staff

        -  If the patient agrees to participate, CTU staff will obtain consent.

        -  The patient will be assigned a participant number.

        -  The patient will read the Fetal Life monitor instructions

        -  Standard tocometry and fetal heart rate devices will be removed

        -  The patient will apply the Fetal Life monitor using the positioning belt and will
           connect to the study iPad or lap top computer via Bluetooth

        -  Fifteen minutes of monitoring will be captured via the iPad or lap top computer by CTU
           staff

        -  During this time, the patient will note when she perceives the beginning and the end of
           her contractions; this will be documented the Clinical Trials Unit staff with time
           notations

        -  Fetal Life monitor will be removed and the standard external fetal monitoring will
           resume

        -  Patient will complete the patient survey
    

Intervention name(s): Fetal Life tocometer device
Intervention type(s): Device
Intervention description(s): The fetal life tocometer device is a uterine contraction monitor which is less expensive to manufacture than existing contraction monitor devices and which pairs with a smart device rather than a bulky output device.
Intervention model: Single Group Assignment
Intervention model description: The study will use a single group for the intervention as detailed above.
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Labor; Uterine contraction