Patent Application
20180228425
This invention relates generally to a system and a method for evaluation and assessment of uterine activity of a pregnant patient utilizing a workstation with a fetal monitor, such as a tocodynamometer external pressure sensor (TOCO) or an intrauterine pressure catheter (IUPC).
Recently the obstetrics industry shifted its focus to research of accurate assessment and management of uterine activity. The industry has found that excessive uterine activity was associated with abnormal fetal heart rate (FHR) patterns, presumably because of inadequate uterine relaxation time. Shortened relaxation time can lead to excess constriction of the spiral arterioles that provide oxygen delivery to the placenta and fetus, effectively reducing perfusion pressure and thus placenta blood flow.
In 2008, the National Institute of Child Health and Human Development (NICHD) and the American Congress of Obstetricians and Gynecologists (ACOG) worked on a proposal and update to the classification system and terminology for describing uterine activity patterns. The preferred term to describe excessive uterine activity is now known as tachysystole (TS), which is defined as >5 contractions in 10 minutes, averaged over a 30 minute window. In a recent study, it was also discovered that the use of oxytocin or misoprostol, an epidural, hypertension, and induction of labor were associated with an increased risk of TS and the number of TS events have been associated with an increased risk of cesarean delivery compared to vaginal delivery.
Worldwide, cesarean sections (CS) are becoming a concern because CS have quadrupled in less than 2 decades, making CS the most common surgical procedure performed in women of childbearing age. In the United States, the rate is 32%, one of the highest in the world. These new results suggest that clinicians need to start paying closer attention to uterine activity during labor. It is important for clinicians to reach consensus on definitions related to excessive uterine activity and recognize that the term TS addresses only one aspect of uterine activity, that of frequency. Other parameters such as strength, duration, resting tone, and relaxation time are equally important components of the evaluation of uterine activity during labor. Having this global understanding is crucial to the promotion of improved outcomes for both the mom and the fetus.
As such, there is an ongoing need for an improved system and method for assessment and interpretation of uterine contractions.
The present invention provides a uterine activity tool and method to support clinicians during the assessment of uterine activity during labor. The goal of the present invention is to aid clinicians during the decision making process by providing key information to help the clinician evaluate and decide on management of uterine activity, preferably at a patient's bedside. The tool of this invention will serve as an adjunct to individual clinical judgment, allowing the clinician to confirm bedside assessments.
At a high level, the uterine activity tool will be able to allow the clinician to select and analyze a uterine activity tracing segment during the intrapartum period. Preferably, the tool of this invention will provide a clinician with a uterine activity tracing showing and identifying a start point, a peak, an end point and any other important characteristic of each contraction and calculating a number of important characteristics of the contraction to assist the clinician to evaluate the contractions. The uterine activity (UA) tool of this invention also preferably allows the clinician to modify the start point, the peak and/or end point of the contraction (emphasized area) by simply clicking on the strip or tracing, before any calculation takes place. The tool of this invention displays uterine contraction average frequency based on a 10, 15, 30, or 60 min segment at any time period defined by the clinician. In an embodiment of this invention, the tool can display uterine contraction duration when a tocotransducer (TOCO) is being utilized. In another embodiment, the tool may display uterine contraction intensity, duration, relaxation time, and resting tone when an intrauterine pressure catheter (IUPC) is utilized. Use of the IUPC also allows the tool to calculate Montevideo units (MVUs). The tool of this invention may also allow the clinician to add, edit, or remove contractions if results do not match the clinician's visual assessment. The tool allows the clinician to confirm tool evaluation results or clinician's modifications and add UA information to notes and flowsheets. Clinicians are able to utilize the Uterine Contraction Evaluation tool on active traces as well as archived traces. The UA tool of this invention also provides a robust interface capable of sending the information to any EHR system.
Other advantages will be apparent to those skilled in the art from the following detailed description taken in conjunction with the drawings.
These and other objects and features of this invention will be better understood from the following detailed description taken in conjunction with the drawings, wherein:
Within the context of this specification, each term or phrase below will include the following meaning or meanings.
Frequency: Contraction frequency overall generally ranges from 2 to 5 per 10 minutes during labor, with lower frequencies seen in a first stage of labor and higher frequencies during a second stage of labor.
Duration: Contraction duration remains fairly stable throughout the first and second stages, ranging from 45-80 seconds and not generally exceeding 90 seconds.
Strength: Uterine contractions generally range from peaking at 40-70 mmHg in the first stage of labor and may rise to over 80 mmHg in the second stage. Contractions palpated as “mild” would likely peak at less than 50 mmHg if measured internally, contractions palpated as “moderate” or greater would likely peak at 50 mmHg or greater if measured internally.
Resting tone: Average resting tone during labor is 10 mmHg; if using palpation, should palate as “soft”, i.e., easily indented no palpable resistance.
Relaxation time: Relaxation time is commonly 60 seconds or more in the first stage, and 45 seconds or more in the second stage.
Montevideo Units (MVUs): One Montevideo unit is equal to exactly 1 mmHg, Montevideo Units are directly equal to pressure change in mmHg summed over a ten-minute window. It is calculated by internally measuring peak uterine pressure amplitude (in mmHg) using an intrauterine pressure catheter, subtracting the resting tone of the contraction, and adding up the numbers in a 10-minute period. Usually range from 100-250 MVUs in the first stage, may rise to 300-400 MVUs in the second stage. Contraction intensities of 40 mm Hg or more and MVUs of 80-120 are generally sufficient to initiate spontaneous labor.
Assessment of uterine activity: Includes the identification of contraction frequency, duration, strength or intensity, and resting tone.
Tachsystole: Contraction frequency of greater than 5 in 10 minutes, averaged over 30 minutes; applies to spontaneous or stimulated labor.
Inadequate relaxation time: Less than 60 seconds uterine relaxation between contractions during the first stage of labor; less than 45-50 seconds uterine relaxation between contractions in the second stage.
No pushing (NP): No pushing mode.
The present invention provides a uterine activity monitoring and assessment system 10 and methods of use thereof. The system 10 of this invention is designed to develop and support best practices in obstetrics, with a goal of providing clinicians with key information to help evaluate and decide on management of uterine activity at a patient's bedside. In a preferred embodiment, the system 10 will support a clinician's judgment, allowing the clinician to confirm bedside assessments.
Those skilled in the art and following the teachings herein provided will appreciate that while the descriptions below include preferred configurations, such configurations are used for illustrative purposes only and may be modified, as appropriate, depending on need.
The uterine activity system 10 of this invention is designed to provide users, such as clinicians, with key information to help evaluate and decide on management of uterine activity of a pregnant patient,
In another embodiment, the uterine activity system 10 may comprise the workstation 16 connected to the fetal monitor 18. In this embodiment, the workstation includes an interface, a data processor and memory sufficient to operate the uterine activity system 10 of this invention. This embodiment may not include servers.
The uterine activity system 10 allows a clinician operating the workstation 16 to select and utilize a uterine contraction evaluation tool during a patient's intrapartum period. The clinician begins by logging into the system from the workstation 16. The clinician then selects a patient, and loads an associated trace. The system will preferably work with either an active trace or an archived trace.
In a preferred embodiment of this invention, the uterine activity tool 30 will detect if the fetal monitor 18 comprises one of a tocodynamometer external pressure sensor (TOCO) or an intrauterine pressure catheter (IUPC) that is connected to the patient and the fetal monitor or, in the case of a saved or archived trace, if the trace was created using the TOCO or the IUPC. The system will then display either TOCO or IUPC in the Mode field 52. If the system of this invention detects a trace that is a crossover of an IUPC and TOCO trace, then the system shall assume the segment range is all external and follow the external algorithm.
In a preferred embodiment of this invention, contraction identifying symbols, including a start 34, a peak 36 and an end 38, are calculated by the system and displayed on the uterine activity trace 28 within the segment range start line 32 and the segment range end line. In the embodiment shown in
In a preferred embodiment of this invention, after reviewing the contractions automatically marked by the UA tool 30, the clinician may adjust placement of the symbols denoting the start 34, the peak 36, and the end 38 of each contraction, based on clinical judgment. Upon confirmation by the clinician, the uterine activity tool 30 then displays vital information for assessment and documentation of uterine activity, including date, time, mode, interval, contraction frequency, contraction duration, contraction intensity, resting tone, relax time, calculated Montevideo Units (MVUs) if IUPC is in use, and number of contraction in the chosen time period. The clinician may then choose to accept the values provided by the UA tool 30, or edit these values prior to adding the values to the patient's chart.
The method of removing one set of contraction identifiers starts by selecting one of the symbols 34, 36, 38 of the contraction that needs to be excluded and selecting the ‘(−) Remove’ option from the context menu 40. Selection of the symbol 34, 36, 38 may be accomplished by right-clicking on a mouse connected to the workstation 16. However, other methods and other types of interfaces may be used in connection with the workstation 16 to select the symbol 34, 36, 38. Upon selection, the context menu 40 automatically closes and all three contraction marking symbols for the selected contraction, are removed simultaneously. The contraction count window 42 at the bottom center of the UA Tool 30 web window is also preferably automatically updated based on the number of contractions removed. Note that the contraction markers are removed and the contraction is no longer included in calculations, but the uterine tracing is unchanged.
Repositioning one of the symbols 34, 36, 38 for the contractions can be accomplished by selecting the symbol with a left-click of the mouse and dragging the selected symbol to another position on the trace 28. Releasing the mouse button will set the symbol in a new position. Other methods and other types of interfaces may be used in connection with the workstation 30 to select the symbol and adjust the symbol as appropriate. In a preferred embodiment, a repositioned symbol will change color or otherwise indicate that the symbol has been manually changed to help a clinician differentiate repositioned symbols from those automatically detected by the system 10. The clinician user will be able to reposition multiple symbols however, preferably, the clinician may only reposition one symbol 34, 36, 38 at a time. Preferably, the symbol being moved will not be able to cross an x-coordinate of any other symbol on the trace 28. When the selected symbol is moved into an area that does not meet the specified contraction criteria, the selected symbol will preferably return to the original starting position.
In situations where the uterine activity tool 30 did not identify a contraction but the clinician visually identifies a contraction, the uterine activity tool 30 provides way for the clinician to add a contraction(s) prior to documenting. Adding the contraction starts by right-clicking on the uterine activity tracing 28 on the contraction that needs to be added. This step opens the context menu 40 and the clinician selects ‘(+) Add Ctx.’ The uterine activity tool 30 adds all three symbols 34, 36, 38 where the clinician clicked. The clinician must then reposition, as described above, the start symbol 34, the peak symbol 36, and the end symbol 38 as necessary to identify the contraction. In an alternative embodiment, the uterine activity tool 30 will identify and place the start symbol 34, the peak symbol 36, and the end symbol 38 at an appropriate position to identify the contraction. In a preferred embodiment, the uterine activity tool 30 will not allow the clinician to place a new contraction in the middle of another identified contraction. Preferably, when attempting to place a new contraction in the middle of another identified contraction, the ‘(+) Add Ctx’ option on the context menu 40 will be dimmed and unavailable for selection. In an embodiment of this invention, the clinician will not be able to add a new contraction outside of the segment. In a preferred embodiment, the manually added contractions will be identified with the symbols or a segment of the trace labeled with a new color or another identifier.
The uterine activity system of this invention preferably allows the clinician to automatically calculate Montevideo units (MVUs). MVUs are calculated by subtracting a baseline uterine pressure from a peak uterine pressure of each contraction in a 10-minute window of time and then taking the sum of these pressures. Two hundred Montevideo units or more is considered adequate for normal labor progression. The system of this invention calculates the MVUs when the intrauterine pressure catheter is used as the fetal monitor input 18. In a preferred embodiment, the clinician is unable to select ‘Start MVU Calc’ from the context menu 40 when the tocodynamometer external pressure sensor is used as the fetal monitor input 18. The clinician starts by accessing the patient on the workstation 16, selecting a segment for trace evaluation using the E-Tools context menu 90, and reviewing the patient's uterine activity tracing 28 on the trace review screen 24. The clinician may then select, preferably by right-clicking, a start point for calculating MVUs 44 on the uterine activity trace 28 and selecting ‘Start MVU Calc’ on the context menu 40. In a preferred embodiment, in order for MVUs to calculate, the clinician will need to select at least a 10-minute period. If the uterine activity tool 30 was selected for a 10-minute segment, the MVUs calculation start point 44 will be auto-selected from the beginning of the segment 32, if not selected, as shown in
In a preferred embodiment of this invention, the clinician is able to confirm the identified contractions are accurate by selecting a Confirm button 46. During a confirmation process, the uterine activity system 10 will calculate a contraction data within the designated segment. In operation, the clinician accesses a patient's uterine activity tracing 28 on the workstation 16. The clinician assesses the uterine activity tracing 28 and modifies the contractions and/or tracing as necessary. When Assessment is completed, the clinician selects the confirm button 46 and a UC note entry section 48 becomes enabled, as shown in
Preferably, a mode field 52 is automatically filled with TOCO when the fetal monitor 18 comprises a tocodynamometer external pressure sensor and the mode field 52 is automatically filled with IUPC when the fetal monitor 18 comprises an intrauterine pressure catheter (IUPC). The mode field 52 is preferably not editable by the clinician.
A Frequency Field Behavior field 54 is also shown in
In a preferred embodiment, the uterine activity tool 30 calculates and populates a duration behavior field 58. The duration behavior field 58 preferably includes a first duration text field 96 showing a shortest contraction duration measured for all positively identified contractions within the segment range. The duration behavior field 58 preferably also includes a second duration text field 98 showing a longest contraction duration measured for all positively identified contractions within the segment range. Duration values in each of the fields preferably range from 10 to 480 seconds. In a preferred embodiment, the clinician may edit the duration fields after the automatic calculation. In an embodiment, the duration values may be increased and/or decreased in increments of 5 seconds using spin box controls.
In an embodiment of this invention, the uterine activity tool 30 also calculates and populates a relax time behavior field 60. A Relax Time behavior is calculated as time between the end point and the start point of each pair of positively identified contractions and displays an average for the selected segment. As shown in
When the system of this invention detects the IUPC is being used, a MVUs field behavior 6 box is enabled. In an embodiment, the MVUs field box 66 is not a required field. In a preferred embodiment, in order for the system to calculate MVUs, the clinician must select at least a ten-minute segment. Alternatively, the ten-minute segment will be auto-selected by the system. As shown in
In a preferred embodiment of this invention, a UC note history section 56 is included in the uterine activity tool 30. In the embodiment shown in
After data is collected, calculated and evaluated, the system 10 of this invention allows the clinician to save the data into patient's chart. Preferably, after saving, the data is available in notes and flowsheets. The clinician logs into the system 10, selects a patient, and displays the patient's associated uterine activity tracing 28. As previously described, the clinician uses the uterine activity tool 30 to select the UA trace segment range, evaluates the contractions, and selects the Confirm button 46 to confirm the contractions. Upon confirmation, the UC Notes Entry 48 will become active, an Add Notes button 116 becomes enabled, and a Go To Notes button 74 becomes enabled. As shown for example in
In the embodiment shown in
When the UC Notes Entry 48 is first enabled, all the fields will be populated with the in formation just captured from the UA Tool 30. Under Toco mode, the intensity field behavior 62 and the resting field behavior 64 text boxes will not be auto-populated. The clinician will need to select values from the drop down boxes 104, 106. In a preferred embodiment, if the user removes a value leaving a required field empty, the add notes 116 button will become disabled, “greyed out”, until the required fields are populated. For the Toco mode, the required fields include frequency 54 and duration 58. For the IUPC mode, the required fields elude frequency 54, duration 58, intensity 62, and resting 64. When the required values are reentered, the add notes 116 button becomes enabled. Clicking the “add note” button 116 preferably causes the following actions to occur: UC Trending updates, values are cleared and Add button becomes disabled, the system sends all values to notes, and notes generated by UA Tool will be available to reports. Flow sheets will also be configured to display the uterine contraction values.
When adding information into the system, whether through entry into the UC notes entry 48 and/or the notes entry 120, the system of this invention shall keep track of the date, time, and user. The note time entered for the note will represent the end time and date of the selected segment range (i.e., in the 11:56-12:06 segment range, the time charted shall be 12:06 pm—late entry). The system will also keep track of the entry time when the user selects the Add option. In another embodiment, there will be no identification of the segment length in notes.
In a preferred embodiment, the clinician, after reviewing the uterine contraction evaluation information, is able to go directly to a notes module to continue charting information. As shown in
The clinician may also close the uterine activity tool 30 without saving any of the information by selecting a Close button 78 as shown in
In an embodiment of this invention, the clinician may need the ability to retrieve a last value entered in the keyword 124 UC Eval. The clinician logs in and selects a retrieve last value button 80 and the last values stored to the database are displayed, whether saved from the UC Eval Confirmation Screen or saved after a manual entry in the OBIX Notes nodule 120. Category and keyword used will be the same as current Notes/UC Eval. This function occurs on all Notes/maternal/intrapartum or intrapartum multiples/UC Eval keyword.
In a preferred embodiment of this invention, the clinician is able to view information that was charted using the add button from the UC Evaluation confirmation screen. In the embodiment shown in
In an embodiment of this invention, a date and time displayed will be an end of the segment range stored during the UC Notes Entry 120 process. For example, if the segment range at time of confirmation was 12:56-1:06 pm (Entry Time) then the time displayed on this row will be 13:06 (Note Time) as military time applies. In a preferred embodiment, the clinician logged into the system at the time of UC Notes Entry will be the clinician displayed in notes review. In a preferred embodiment, the notes review/complete (including type) will remain the same as an evaluation added from the Notes module 120. When the user clicks “Add” on the tool to chart, the type, status, and trace column codes will remain the same as if the user utilized Notes to chart. In a embodiment of this invention shown in
In a preferred embodiment, the system of this invention will allow a clinician to run a labor assessment and labor quality assessment flowsheet report 84 that includes all the information that was documented using the UA tool 30. The clinician will log in and access the UA tool 30. The clinician will then access flowsheets 84 by selecting Flowsheets>Intrapartum>Labor Assessment Uterine Contractions Evaluation section.
The invention illustratively disclosed herein suitably may be practiced in the absence of any element, part, step, component, or ingredient, which is not specifically disclosed herein.
While in the foregoing detailed description this invention has been described in relation to certain preferred embodiments thereof, and many details have been set forth for purposes of illustration, it will be apparent to those skilled in the art that the invention is susceptible to additional embodiments and that certain of the details described herein can be varied considerably without departing from the basic principles of the invention.
This application claims the benefit of U.S. Provisional Patent Application, Ser. No. 62/459,420, filed on 15 Feb. 2017. The co-pending Provisional Application is hereby incorporated by reference herein in its entirety and is made a part hereof, including but not limited to those portions which specifically appear hereinafter.
| Number | Date | Country | |
|---|---|---|---|
| 62459420 | Feb 2017 | US |
