WO2007110625A2 - Device for prediction of human or other mammalian labour onset - Google Patents
Device for prediction of human or other mammalian labour onset Download PDFInfo
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- WO2007110625A2 WO2007110625A2 PCT/GB2007/001091 GB2007001091W WO2007110625A2 WO 2007110625 A2 WO2007110625 A2 WO 2007110625A2 GB 2007001091 W GB2007001091 W GB 2007001091W WO 2007110625 A2 WO2007110625 A2 WO 2007110625A2
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- labour
- data
- onset
- peak
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/24—Detecting, measuring or recording bioelectric or biomagnetic signals of the body or parts thereof
- A61B5/316—Modalities, i.e. specific diagnostic methods
- A61B5/389—Electromyography [EMG]
Definitions
- the present invention relates to a device for the prediction of the onset of labour in humans or non-human mammals, a method for predicting labour using the device and the use thereof. More specifically the invention relates to a device for predicting the onset of labour which may be premature, on time or delayed relative to an initial estimate, a method of using the device, to facilitate operation by the subject or another individual who is not a clinician, and the use thereof.
- WO 94/14373 (Garfield) records signals from embedded electrodes
- WO 95/31932 and WO 96/39931 (Garfield) disclose a method which stores data and compares activity
- US 5,373,852 (Harrison) uses radiotelemetric transmission for sensing pressure, temperature and electrical activity
- WO 97/25922 (Rosenberg) discloses a further method for analysis of electromyographic data.
- biomarkers present in body fluid which may indicate the uterus 's preparation or readiness for labour.
- the use of such biomarkers will present the patient with the challenge of body fluids sampling and test interpretation at home if they are to come into widespread use.
- WOO 1/45555 (Simpson & Walker) describes a device for prediction of onset of labour comprising a portable assembly of: a plurality of recording electrodes and optionally a reference electrode, each electrode comprising a contact surface for application to a subject, and in particular to an abdominal and/or vaginal surface of a subject; a means for data acquisition; a means for conversion of analogue to digitised data; a data analysing means to process the data to determine a result indicative of uterine preparedness for labour; and a display adapted to display this result.
- the device can be operated by a non-expert, it relies upon complex data analysis of frequency shifts and advanced frequency spectral analysis to determine the state of uterine preparedness.
- the present invention is directed at the provision of an alternative device and method, and in particular a device and method based on less complex data processing principles, for home or other non-clinical use to improve accuracy of the predicted delivery date in any pregnancy.
- the invention is in particular directed at provision of a non-expert system which will provide an indication of imminence of onset of labour during any pregnancy and for any purpose, and not merely where a clinical need or abnormality is identified.
- a device for prediction of imminence of onset of labour comprising a portable assembly of: a plurality of recording electrodes and optionally a reference electrode, each electrode comprising a contact surface for application to a subject, and in particular to an abdominal and/or vaginal surface of a subject; a means for data acquisition; a data analysing means to process the data to determine a result indicative of the electromyographic readings of the subject and a display adapted to display this result.
- the device is characterised in that the data analysing means comprises a means adapted to produce a result indicative an electromyographic parameter known to vary cyclically in the period preceding labour, a data register to store previous results, and a data comparator to compare a currently generated result with previous results and thereby to identify a peak in the said parameter.
- the data analysing means comprises a means adapted to produce a result indicative an electromyographic parameter known to vary cyclically in the period preceding labour, a data register to store previous results, and a data comparator to compare a currently generated result with previous results and thereby to identify a peak in the said parameter.
- Readings are taken consistently periodically, for example once a day, preferably at a consistent time.
- the device identifies and indicates a parameter peak (for example, it identifies and indicates this when a given measured data reading is determined by the comparator to be lower than the most recent stored equivalent data reading in the data register).
- the principles of the invention can be applied to any parameter derivable from successive readings of electromyographic potentials of a subject which can be shown to vary cyclically in a consistent manner to the extent at least that it delivers a characteristic peak at a sufficiently consistent time period in advance of the onset of labour to make the peak serve as a marker from which a more accurate indication of the imminence of onset of labour can be derived.
- a characteristic peak is used to refine a previously obtained estimate of labour onset, which may for example have been derived as a delivery estimate in an entirely conventional manner, or by some other data analysis technique. Such a previous estimated delivery date may similarly be stored within the system on a suitable data register.
- the data analysing means comprises a means adapted to produce a result indicative of the total energy level within at least one specific narrow band of the overall frequency spectrum for electromyographic data. It has surprisingly been found that if a narrow band is resolved from the spectrum such energy levels are cyclical during pregnancy and that a final peak occurs 7 to 14 days before labour onset.
- an indicated peak can provide a simple way of indicating labour onset and improving the accuracy of an initial prediction, in that, in a simple mode of operation, a peak within 15 days of predicted delivery can be taken as such an indicator.
- the comparator On identifying such a peak, the comparator causes a suitable indication to be made via the display.
- the device works best when separate recordings are obtained for consecutive days or sessions during gestation in the third trimester whereby the energy patterns in the frequency bands of electrophysiological activity from the patient can be ascertained.
- At least one narrow frequency band is used, and data indicative of the energy within the band is produced by the acquisition and analysis means.
- Data across a plurality of such narrow bands within the overall spectrum may be used.
- Frequencies in the range 0 -5 Hz recorded from the mother have been found to be particularly useful in the determination of cyclic energy patterns and have been grouped in short intervals.
- a suitable frequency interval for such a narrow band to perform the analysis in accordance with the invention is of 0.2 to 0.5 Hz, and most preferably around 0.25 Hz.
- Suitable narrow frequency bands across which total energy may be determined in accordance with the invention might be 0 to 0.25 Hz, 0.25 to 0.50 Hz etc.
- the frequency bands may be narrowed or extended as required.
- the energy in each frequency band relative to the overall energy in the total signal is produced as the result indicative of the energy within the band. This minimises day to day fluctuations such as skin impedance during electrical recording etc.
- the actual total energy in the signal for the recording session in individual frequency bands could be derived and used as the result.
- the device records uterine electrical activity, in particular by application to the abdominal or vaginal surface, in generally similar manner to that known in the art. That is to say, a plurality of recording electrodes for measuring action potential are provided which are applicable to an abdominal or vaginal surface of a patient under analysis, conveniently an analogue to digital converter connected to the electrodes acts to convert electromyographic signals produced by the electrodes into digitised data indicative of the electromyographic signals and action potentials.
- the optionally digitised data are stored and analysed with reference to previously recorded results and optionally predetermined reference parameters, the results being used to actuate a display adapted to display this data as indicating imminence of labour.
- the invention differs from most of the prior art by exploiting the surprising result that analysis of uterine electrical activity can be used not merely to monitor the progress of, and/or diagnose active labour as in the prior art, but can be used to obtain an indication of uterine preparedness for labour in the initial phase of parturition before onset of active labour.
- analysis of uterine electrical activity can be used not merely to monitor the progress of, and/or diagnose active labour as in the prior art, but can be used to obtain an indication of uterine preparedness for labour in the initial phase of parturition before onset of active labour.
- the ability to utilise such analysis in a predictive manner was first described in WOO 145555 but this current invention develops a simple but effective data analysis technique to produce a device that significantly extends the abilities of analysis and prediction.
- the data analysis means performs at least one such an analysis to determine a cyclical peak in at least one such narrow frequency range. It is not intended that the device should be limited only to such an analysis. A device in accordance with the invention may further refine any resultant estimate by being adapted to carry out further data analysis.
- the data analysis means includes a burst counter that allows for the identification of classical electrical burst activity over a predetermined recording period, containing a range of frequencies, the comparator being adapted to identify a peak in such data (again, for example, by indicating when a measured burst count is below the most recent recorded burst count).
- burst activity has been noted in the past to be of greater strength and frequency during labour.
- the current device is able to measure the occurrence of such activity which is present before and during labour onset and the pattern of such activity is discerned by the device.
- the first and second markers of the first and second principal embodiments are combined.
- the combination device thus identifies two markers which successively enhance the accuracy of a prediction of likely labour onset.
- the device identifies a cyclical peak in the total energy (and in particular in the relative total energy) of at least one narrow frequency band across the usual spectrum in the manner above described.
- Suitable narrow frequency bands across which total energy may be determined in accordance with the invention might be 0 to 0.25 Hz, 0.25 to 0.50 Hz or like width bands up to a typical maximum frequency of 5 Hz.
- other higher or lower frequency bands may be examined in similar manner
- the incidence of such a peak that occurs within 15 days of an original estimated date is treated as a first marker, and delivers a result that onset of labour is expected within a first period, typically 7 to 14 days.
- the device identifies a second marker comprising a peak in the burst activity count over a consistent recorded period, and this peak is referred as a second marker indicating that onset of labour is even more imminent, for example, within 3 to 5 days.
- the device and method of the invention is predictive rather than merely diagnostic of labour it enables subjects to determine the expected onset of their labour with accuracy. Whilst such a tool might have value in giving advance warning of abnormal premature labour allowing timely measures to be taken to provide medical assistance where necessary in the instance of premature labour in advance of the event itself, thereby allowing for example preventative action, simplifying any remedial action and reducing premature birth problems, it is also of use in monitoring the progress of routine pregnancy.
- the invention makes a particularly useful contribution.
- Onset of labour is still hard to predict, both because of the approximate nature of the original calculation and because of the statistical spread between early and late delivery that is a feature of a perfectly healthy pregnancy.
- the device and method help to avoid false alarms which are distressful and an undue cost burden on the medical services. They improve resource allocation in providing support services during normal pregnancy. They allow a human mother to make a prediction for social purposes, for example to allow for the prospective mother to organise her support some days prior to the birth of her child. They allow a livestock manager to make a prediction for economic purposes, to organise stocking practice more efficiently.
- the apparatus includes signal digitisation means to digitise the collected analogue signal before processing by the analysis means.
- the digitisation of the signal is for current computational convenience but in other embodiments of such a device analogue means of manipulation could be envisaged.
- Readings are taken periodically, for example once or twice a day, preferably at a consistent time. Data are preferably collected for a consistent period.
- the apparatus conveniently includes timer means to time the data collection period, acting with the data retrieval means to ensure each data collection takes place over a fixed period. Conveniently this automatically starts data retrieval and ends data retrieval at the end of the period.
- the data retrieval period is user controlled, and the timer serves to advise the user, for example via the display means or visual or audio alarm, that the collection period is complete.
- the device includes a reminder system, for example acting via the display means or a visual or audio alarm, to remind a user when each successive data collection action is due.
- the display is adapted to work in conjunction with the comparator to provide a simple display indicating a data peak, and thus indicating imminence of onset of labour.
- a two-state model indicating a positive or negative result for a peak in the or each narrow band cycle or a three-state model indicating this first peak marker and a second marker based on the burst analysis may be provided.
- the apparatus preferably further includes means to input and store an initial estimated delivery date for example in the form of a delivery date register.
- the analysis means may then reference this stored date in assessing whether an identified cyclical peak in narrow band total energy is close enough to the predicted date to be representative of imminence of onset of labour as above.
- the display is adapted to display a positive result only if the comparator detects a peak and the analysis means shows this criterion of proximity to the delivery date estimate to be met.
- the present invention thus enables a prediction of the onset of labour and/or a monitoring of the pre-labour phase of parturition, as the uterus prepares for the contractile or labour phase of parturition. Moreover, the invention does this in a compact and portable manner, and by displaying only a small number of discrete results, provides a result which can be readily interpreted by a subject without the need for intervention by a clinician, and is thus particularly suited to home use. For example, given the peak analysis on the two markers discussed above, a reading can be given at 7 to 14 days from onset of labour, and a further reading at 3 to 5 days.
- the present invention in considered to provide highly reliable results based on the finding that certain parameters govern the production of uterine electrical signals.
- the device makes it possible to pre-record reference data and/or to pre-programme particular reference parameters which are characteristic of a small number of pre-defined pre-labour states indicating the progress of preparedness for contractile labour.
- data are pre-recorded and/or parameters are pre-programmed which correspond to uterine electrical activity indicative of the pre-parturition state and uterine activity indicative of a state of full or near full uterine preparedness for active contractile labour, and the display means are configured to display one or other state accordingly as a positive/negative result.
- further data and/or parameters are stored representative of one or more intermediate states as the preparation phase of parturition has progressed to a greater or lesser extent. A comparison of changes in electrical activity against these referenced parameters can offer an indication of the imminence of full preparedness for labour.
- the device thus offers a tool which is not diagnostic of active labour but is predictive of the onset of labour by enabling monitoring to be made during the preparation phase of parturition. Moreover, the device achieves this objective in a compact and portable manner which is particularly suited for home use.
- the display of the invention is adapted to display the collected and analysed data in terms of one of a small number of discrete results indicating the imminence of onset of labour.
- the digitised data indicative of uterine electrical activity is compared with suitable pre-recorded reference data and/or predetermined reference parameters by the data analyser and is characterised as being indicative of a state of preparedness corresponding to one of the said discrete results, and the display is then actuated to make such an indication.
- the display may be configured to indicate a positive or negative result as to whether the uterus is substantially prepared for contractile labour and onset of labour is imminent.
- a positive or negative result as to whether the uterus is substantially prepared for contractile labour and onset of labour is imminent.
- WO0145555 describes that detectable electrical changes occur within the uterus over this time.
- detectable changes can be obtained for many subjects at least eight weeks before the onset of labour, and these detectable changes can therefore be used to effect an intermediate reading where labour is approaching but not yet imminent.
- the device therefore displays negative/intermediate/positive results, which for practical purposes from the perspective of the subject could be thought to correspond to: labour distant (retest in a week or so)/ labour likely in a week or two (retest daily, remain prepared to initiate deliver procedures)/ labour imminent (prepare for onset of labour, treat any symptoms as probable labour).
- Display means may be auditory, visual or both and conveniently indicates a result without the need for the subject to interpret levels or the frequencies of activity, i. e., in the form of a set of illuminating lights, tactile patterns such as vibration or discrete auditory signal or alarm or an alphanumeric display to display simple messages.
- multi-state embodiment such as the preferred three-state embodiment, multi-coloured lights may be used, each colour indicating a different state of preparedness.
- the display means preferably includes at least an alphanumeric display to display simple instructional or informational messages, in particular messages to this effect.
- the display may now also indicate with some certainty after a predictive session that has identified the first above marker (peak in energy across a narrow band) 'Labour onset is expected within 7 to 14 days' and count down daily from this prediction in the screen messages to the expectant mother.
- the device will be able to further predict as the countdown continues and identifies the second predictive marker (peak in burst count) 'Labour onset now likely in 3 to 5 days' or some such equivalent message.
- the particular advantage of present invention is that the display means can give simply understandable results which do not require the intervention of a clinician and which offer the potential for significant reduction in both false alarms and unexpected early labour producing complications because of inaccessibility of medical assistance.
- the device detects spread of electrical impulse throughout the uterus, and may classify as a range, in the scale of 0-100% intercell connection within the uterus.
- the device of the invention suitably comprises any means for operatively associating the assembly of components such as a casing, mounting, cassette, card, frame or the like.
- a mounting may be rigid or flexible, for example a flexible mounting may comprise an article of clothing such as a belt, patch or the like which may be conveniently worn by the subject for prolonged periods without inconvenience.
- the device may be manually operated or may comprise means for intermittent operation allowing periodic inspection on a regular basis.
- Activation may be manual or automated for example as a periodic activation using a timer control means, and/or as a manual activation such as through a power switch.
- the device preferably incorporates a portable power supply such as a rechargeable or non-rechargeable battery. Additionally or alternatively means are provided to connect the device to a mains power supply.
- the comparator compares previous responses stored in a data register, in particular to determine a cyclical peak in energy across at least one resolved narrow band and/ or a peak in burst count.
- the data register may also be provided for input of pre-recorded data indicative of known pre-parturition electrical responses.
- the comparator may be adapted further to reference this data to refine and confirm any result analysis. Comparison with pre-recorded data maybe with data programmed by a medical supervisor, for example enabling detection of a particular condition or pre-labour period or combinations thereof as alternative or co-operative settings. Alternatively the pre-recorded data may be acquired by the device in a programming mode by the subject in a non-labour and in particular a preparturition condition in simple manner.
- the device operates by analysing several consecutive sessions from a patient to identify cycles in electrical energy levels at different frequencies from the recorded signal and to record burst activity from the uterus on a daily or frequent basis.
- the patient should start daily recordings 25 to 30 days before the estimated due date (EDD).
- EDD estimated due date
- a session of recording may vary from a few minutes to longer.
- EDD estimated due date
- a predictive value of labour onset with a 7 to 14 day period from a characteristic peak in the energy cycles is possible.
- By further adding the count and pattern of burst activity before labour we can further predict a 3 to 5 day period to labour onset. It has been identified importantly that the frequency of burst activity (number of bursts in a fixed time recording session) rises to a peak in the 3 to 5 days before labour and then falls off. Identification of this peak provides and additional prediction of labour onset
- Data acquisition and digitisation is suitably carried out by means of a microprocessor or other computing means associated co-operatively with the electrodes using known techniques.
- Data analysis is by any suitable means and method associated with parameters related to change in electrical signals.
- the signals are analysed by performing a spectral analysis of power density of electromyographic potentials to determine total energy across one or more narrow frequency bands, and the analyser is adapted to perform such an analysis, for example by suitable programming.
- the preferred frequency analysis method for analysing the signal comprises producing a power spectrum, and thereafter analysing the total energy in specific narrow frequency bands with respect to all energy in the total recorded signal.
- the analyser is adapted to perform such an analysis (e. g. by suitably programming).
- a suitable overall frequency range for measurement is up to 5 Hz.
- a suitable narrow frequency band is 0.2 to 0.5 Hz in width, and for example around 0.25 Hz.
- a particularly useful indicative frequency band is found to be 0.25-0.5 Hz, and in a preferred embodiment the data collection and analysis means is adapted to determine total energy at least across this band.
- the energy contained in the specific frequency bands is recorded by the analyser and compared on a day to day or session to session basis by the comparator at least to identify a cyclical peak.
- the emergence of peaks in total energy contained in any one frequency band when compared with EDD analysed alone leads to improved predictions of labour onset. For example, if the total energy in the frequency band 0.25-0.5 Hz of the signal recorded is found to be reaching a peak with 15 days of the EDD then labour onset can reasonably be predicted to follow within 7 to 14 days and the device and analyser can be adapted to give such a refined indication of imminence of labour via a suitable message on the display. Alternatively a pattern of the energy totals or ratio in the 0.25-0.5 Hz band may be observed over a number of days. Regular occurrence in rise and fall of energy in the days before labour is indicative of the approach of labour onset.
- Other frequency bands may be used as may other means of analysing the rise and fall of the energy within the band.
- the total power, measured as the area under the above within the range of frequencies is also significant.
- the device will also count or otherwise monitor how frequently bursts of electrical activity are found in the recorded signal.
- the pattern of frequency of burst activity change before labour, rising to a peak and then falling off and the device will analyse this and display a message to the user about labour onset. Therefore for example a peak in the amount of bursts occurring in a session followed by a sharp fall of in burst activity in the subsequent sessions indicates that labour onset will follow between 3 and 5 days later.
- Data analyser and display means operating this preferred embodiment of the invention thus comprise an analyser such as a microprocessor or filter adapted, for example suitably programmed, to split data into frequency bands, to perform an analysis of energies within bands and to record and compare these from session to session, to detect and record burst activity and note its number of occurrences in any one session, to compare such burst activity on a session to session basis, and to have the means to display in software appropriate indicative messages of the imminence or not of labour onset.
- an analyser such as a microprocessor or filter adapted, for example suitably programmed, to split data into frequency bands, to perform an analysis of energies within bands and to record and compare these from session to session, to detect and record burst activity and note its number of occurrences in any one session, to compare such burst activity on a session to session basis, and to have the means to display in software appropriate indicative messages of the imminence or not of labour onset.
- the present invention thus provides means for displaying frequency-analysed electrohysterographic data in form of a small number of discrete results such as a positive or negative result and optionally further one or more intermediate results, in particular results which indicate not merely a diagnosis of labour, but a prediction of its likely onset.
- Burst activity is obvious to the eye of the trained observer looking at recordings from the abdomen or uterus of a pregnant woman and is most simply recorded in this manner but can equally be embodied in a device by using mathematical algorithms that detect, shape, amplitude or frequency components of the incoming signal.
- a method for predicting onset of labour comprising applying the principles of a device as hereinbefore defined to the skin of a subject in the uterine region, activating the device for a sufficient period to record electrical activity and obtaining a displayed result indicating imminence of labour.
- the method comprises applying potential measuring electrodes to an abdominal or vaginal surface of a patient in the uterine region, activating data acquisition means for a sufficient period to record electrical activity, acquiring data corresponding to the electrical activity, and resolving at least one data parameter known to vary cyclically in the period prior to onset of labour; repeating the method successively over a period of time, in particular at consistent intervals and for a consistent recording period, comparing the result for the resolved parameter with previous results for the same to identify a peak value; deriving from the known relationship of such peak value to the likely onset of labour a result indicative of the imminence of onset of labour.
- any parameter can be used which has a characteristic peak displayed a consistent time period before the onset of labour.
- the method is used to identify a peak in the parameter, and suitable reference made, either automatically through suitable analysis means in the manner above described, or by user reference or any other suitable means, to the consequent indication which can be derived regarding the imminence of labour.
- the method involves analysing the data by a power frequency analysis technique, and in particular the analysis comprises a tracking of distinct cyclical peaks of energy within discrete frequency bands as above described. Session to session or day to day comparisons of the energies over the period of use of the device are preferable.
- the method comprises the step successively over a period of time of repeatedly analysing the data by a power frequency analysis technique to produce a result indicative of the total energy level within at least one specific narrow band of the overall frequency spectrum for electromyographic and identifying a peak in the successive results.
- the method additionally or alternatively allows the electrical bursts of activity in an session to be discerned, counted and further analysed. Session to session or day to day mapping of the burst activity over the period of use of the device is preferable. A peak is identified as above described.
- the method comprises the step successively over a period of time of repeatedly analysing a count of electrical bursts of activity in a session and identifying a peak in the successive results.
- both analysis methods above are used, the method of this aspect of the invention being modified to comprise the steps of: determining an initial estimate of labour onset/ delivery date; successively at regular intervals analysing the data by a power frequency analysis technique to produce a result indicative of the total energy level within at least one specific narrow band of the overall frequency spectrum for electromyographic data, identifying a peak in the successive results within 15 days of predicted delivery and outputting this identified peak as a first marker of the imminence of onset of labour; successively at regular intervals analysing a count of electrical bursts of activity in a session, identifying a peak in the successive results and outputting this identified peak as a second marker of the imminence of onset of labour.
- Each marker result is preferably displayed, for example via an alphanumeric display means to output the first marker by means of a display 'Labour onset is expected within 7 to 14 days' and to output the second marker by means of a display 'Labour onset now likely in 3 to 5 days' .
- Application of the device may be temporary or permanent, i. e., the device may be applied periodically by the subject or may be worn as part of thick clothing.
- the method may comprise a preliminary non-labour programming stage to acquire non-labour data.
- the method may be operated with a preprogrammed device.
- the use may be human or animal use.
- the device may be used for humans and animals in remote regions enabling them to remain in their natural environment throughout the duration of pre-labour pregnancy and to detect prediction of labour onset for a suitable period enabling travel to assistance.
- the device may be use within the home or in transit, during a subject's normal daily activities in public, in hospitals, clinics and the like. It is a particular advantage that the use is simple, convenient and the device may be operated by skilled or unskilled personnel, by the subject or any other person.
- Figure 1 illustrates an embodiment of the invention in the form of a belt/corset worn device
- Figure 2 is an example of variation in energy in the frequency band 0.25-0.50
- Figure 3 shows burst activity recorded from the abdomen of a pregnant woman across a pair of electrodes
- Figure 4 illustrates the pattern of such burst activity in successive recordings during the days approaching onset of labour.
- a device of four electrodes and reference electrode has been utilised to record electrophysiological signals from the abdomen of a pregnant women.
- the four electrodes are paired such that two electrodes form a channel of input to the device.
- the electrodes may be arranged as to detect transversely or longitudinally the electrical signals spreading across the abdomen of a patient. Data from either or both channels may be analysed independently or in combination.
- a capture/analysis/comparator/display device (1) is mounted on belt/corset (2) connected to recording electrodes (3) and reference electrode (4).
- the device (1) in the example comprises coloured lights (6a, 6b, 6c) indicative of discrete results states.
- three discrete results states are envisaged, generally representing a pre-labour state, an indication when the first marker (peak in narrow band energy level) is detected and an indication when the second marker (peak in burst count level) is detected.
- green, amber and red lights may be used.
- An LCD panel (5) is pre-programmed to display simple alphanumeric information. This may include, for example, approximate time to labour and/or instructions on recommended duration before a re-test is carried out. For example this may display a 7-14 day count when the first marker (peak in narrow band energy level) is detected and a 3-5 day count when the second marker (peak in burst count level) is detected.
- the device is adapted for simple home use by a subject without acquiring any special medical knowledge, to give both reassurance when labour is distant, early warning when labour is not so distant, and a full alert when labour is imminent.
- the device also comprises an on/off switch (7) and a battery panel.
- Typical electrical data obtained after Fourier analysis and calculation of total energy in a frequency band is shown in Figure 2.
- the first peaks in energy may be recorded several weeks prior to onset of mechanical contractions.
- Pre-programmed data and/or pre-programmed reference parameters ensure that this can be interpreted by the device, and displayed as an intermediate result.
- Figure 2 illustrates variation in energy in the frequency band 0.25-0.5 Hz as a fraction of total energy in the signal on a day to day basis in pregnant Patient A.
- Figure 2a illustrates data over the whole period, and Figure 2b over the immediate pre-labour period.
- Several clear peaks and troughs in the signal can be detected visually in Figure 2a. The presence of such peaks in the 15 days before EDD indicates that labour will start within 7 to 14 days.
- labour onset occurs at the end of the x-axis.
- FIG. 3 shows the actual data recorded from the abdomen of a pregnant woman across a pair of electrodes.
- a 50 second trace of electrical signal obtained across a pair of electrodes on the abdomen of a pregnant patient is shown. Two strong bursts of electrical activity and two lesser bursts can be seen.
- a count of the number of all electrical burst in a recording session, say ten minutes of recording, on subsequent days of the pregnancy shows that burst activity reaches a peak a few days before birth.
- Figure 4 shows a graph of a count of the electrical burst in each ten minute recording session for a pregnant patient. It can be seen that the number of burst per session (y-axis) reaches a peak 5 days before labour onset.
- example 1 may be combined with the analysis of example 2 to give two markers of imminence of labour onset, or either used separately as a single marker, to improve upon an initially conventionally derived EDD.
Abstract
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Priority Applications (3)
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CA002663420A CA2663420A1 (en) | 2006-03-24 | 2007-03-26 | Device for prediction of human or other mammalian labour onset |
EP07732152A EP2004046A2 (en) | 2006-03-24 | 2007-03-26 | Device for prediction of human or other mammalian labour onset |
AU2007231122A AU2007231122A1 (en) | 2006-03-24 | 2007-03-26 | Device for prediction of human or other mammalian labour onset |
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GB0605950.5 | 2006-03-24 | ||
GBGB0605950.5A GB0605950D0 (en) | 2006-03-24 | 2006-03-24 | Device for prediction of human or other mammalian labour onset |
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WO2007110625A2 true WO2007110625A2 (en) | 2007-10-04 |
WO2007110625A3 WO2007110625A3 (en) | 2007-12-06 |
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PCT/GB2007/001091 WO2007110625A2 (en) | 2006-03-24 | 2007-03-26 | Device for prediction of human or other mammalian labour onset |
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EP (1) | EP2004046A2 (en) |
CN (1) | CN101448455A (en) |
AU (1) | AU2007231122A1 (en) |
CA (1) | CA2663420A1 (en) |
GB (1) | GB0605950D0 (en) |
WO (1) | WO2007110625A2 (en) |
Cited By (4)
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US9968291B2 (en) | 2009-07-06 | 2018-05-15 | Monica Healthcare Limited | Monitoring uterine activity |
WO2019036032A1 (en) * | 2017-08-18 | 2019-02-21 | Sera Prognostics, Inc | Pregnancy clock proteins for predicting due date and time to birth |
US10392665B2 (en) | 2015-06-19 | 2019-08-27 | Sera Prognostics, Inc. | Biomarker pairs for predicting preterm birth |
WO2020229656A1 (en) | 2019-05-16 | 2020-11-19 | Ava Ag | System and method for precise determination of a date of childbirth with a wearable device |
Families Citing this family (1)
Publication number | Priority date | Publication date | Assignee | Title |
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CN109614840B (en) * | 2017-11-28 | 2022-03-18 | 重庆交通大学 | Premature delivery detection method based on deep learning network |
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- 2007-03-26 CN CNA2007800187020A patent/CN101448455A/en active Pending
- 2007-03-26 EP EP07732152A patent/EP2004046A2/en not_active Withdrawn
- 2007-03-26 WO PCT/GB2007/001091 patent/WO2007110625A2/en active Application Filing
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US9968291B2 (en) | 2009-07-06 | 2018-05-15 | Monica Healthcare Limited | Monitoring uterine activity |
US10392665B2 (en) | 2015-06-19 | 2019-08-27 | Sera Prognostics, Inc. | Biomarker pairs for predicting preterm birth |
US10961584B2 (en) | 2015-06-19 | 2021-03-30 | Sera Prognostics, Inc. | Biomarker pairs for predicting preterm birth |
WO2019036032A1 (en) * | 2017-08-18 | 2019-02-21 | Sera Prognostics, Inc | Pregnancy clock proteins for predicting due date and time to birth |
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WO2020229656A1 (en) | 2019-05-16 | 2020-11-19 | Ava Ag | System and method for precise determination of a date of childbirth with a wearable device |
Also Published As
Publication number | Publication date |
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EP2004046A2 (en) | 2008-12-24 |
CA2663420A1 (en) | 2007-10-04 |
AU2007231122A1 (en) | 2007-10-04 |
WO2007110625A3 (en) | 2007-12-06 |
CN101448455A (en) | 2009-06-03 |
GB0605950D0 (en) | 2006-05-03 |
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