# US 2010/0168528 A1 · Identifying the level of fetal risk during labor > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 2010/0168528 A1 - Document ID: US20100168528A1 - Status: Published application - Kind: A1 - Application number: 12/345,090 - Filed: 2008-12-29 - Published: 2010-07-01 - Earliest claimed: 2008-12-29 - Inventors: Mark Evans - Web page: https://patentgrep.com/patent/US20100168528A1 ## CPC - A61B 5/02411: {of foetuses} - A61B 5/02405: {Determining heart rate variability} - A61B 5/1107: {Measuring contraction of parts of the body, e.g. organ or muscle} - A61B 5/4362: {Assessing foetal parameters} - A61B 2503/02: Foetus - A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D) ## Abstract A method for identifying the level of fetal risk during labor comprises monitoring at least each of the concurrent clinical parameters of (a) FHR, (b) baseline FHR variability, (c) FHR accelerations, (d) FHR decelerations, and (e) maternal uterine activity, to determine whether each parameter independently exhibits at least one non-reassuring characteristic, and indicating a present level of risk to the fetus corresponding to the number of the concurrent clinical parameters (a) through (e) that are simultaneously, independently non-reassuring. An apparatus for implementing the method comprises at least one computer operative to receive input signals indicative of at least FHR and maternal uterine activity in a patient. The computer is operative to determine from the FHR baseline FHR variability, FHR accelerations, and FHR decelerations, to determine when any one or more of the parameters (a) through (e) each exhibit at least one non-reassuring characteristic, and to determine a present level of risk to the fetus corresponding to the number of the parameters (a) through (e) that are simultaneously, independently non-reassuring. At least one output operatively connected to the at least one computer indicates the determined present level of risk to the fetus. ## Claims ### Claim 1 A method for identifying the present level of fetal risk during labor, comprising the following steps: monitoring in a patient at least each of the concurrent clinical parameters of (a) FHR, (b) baseline FHR variability, (c) FHR accelerations, (d) FHR decelerations, and (e) maternal uterine activity to determine whether each concurrent clinical parameter independently exhibits at least one non-reassuring characteristic; and transforming the number of the concurrent clinical parameters (a) through (e) that simultaneously, independently exhibit at least one non-reassuring characteristic into an indication of the present level of risk to the fetus corresponding to the number of the parameters (a) through (e) that simultaneously, independently exhibit at least one non-reassuring characteristic. ### Claim 2 (depends on 1) The method of claim 1, wherein maternal uterine activity (e) is monitored for the exhibition of at least one non-reassuring characteristic independent of fetal response. ### Claim 3 (depends on 2) The method of claim 2, wherein the highest level of risk to the fetus corresponds to the simultaneous, independent exhibition of at least one non-reassuring characteristic for each of the parameters (a) through (e). ### Claim 4 (depends on 3) The method of claim 3, wherein the at least one non-reassuring characteristic for each of the concurrent clinical parameters (a) through (e) is selected from the following: (a) for FHR: any of (i) a fetal heart rate of over 160 bpm or (ii) a fetal heart rate of less than 120 bpm; (b) for baseline FHR variability: any of (i) a variability of more than 15 bpm or (ii) a variability of less than 5 bpm; (c) for FHR accelerations: any of (i) the occurrence of less than two accelerations in 10 minutes of 15 bpm for at least 15 seconds, (ii) the absence of shoulders, or (iii) the presence of overshoots; (d) for FHR decelerations: any of (i) late decelerations, (ii) variable decelerations with slow return to baseline FHR, (iii) the presence of overshoots, or (iv) prolonged FHR deceleration; and (e) for maternal uterine activity: any of (i) repetitive contractions in excess of 5 uterine contractions in 3 consecutive 10 minute windows, (ii) a uterine resting tone of greater than 25 mm Hg, (iii) a contraction duration of greater than 90 seconds, (iv) the coupling or tripling of contractions prior to return to baseline, or (v) a contraction duty cycle of greater than 50%. ### Claim 5 (depends on 1) The method of claim 1, further comprising the step of identifying a predetermined action to be taken in response to the indicated present level of risk to the fetus. ### Claim 6 (depends on 1) The method of claim 1, further comprising the step of identifying the presence in the patient of one or more antecedent clinical parameters which elevate the level of fetal risk during labor, and wherein the transforming step comprises transforming the number of the concurrent clinical parameters (a) through (e) that simultaneously, independently exhibit at least one non-reassuring characteristic and the identified number of one or more antecedent clinical parameters which elevate the level of fetal risk during labor into an indication of the present level of risk to the fetus corresponding to the number of the concurrent clinical parameters (a) through (e) that simultaneously, independently exhibit at least one non-reassuring characteristic and the identified number of one or more antecedent clinical parameters which elevate the level of fetal risk during labor. ### Claim 7 (depends on 6) The method of claim 6, wherein the highest level of risk to the fetus corresponds to any combination of any number of the parameters (a) through (e) that simultaneously, independently exhibit at least one non-reassuring characteristic and any number of the identified number of one or more antecedent clinical parameters which together total six. ### Claim 8 (depends on 6) The method of claim 6, further comprising the step of identifying a predetermined action to be taken in response to the indicated present level of risk to the fetus. ### Claim 9 (depends on 6) The method of claim 6, wherein the one or more antecedent clinical parameters are maternal antecedent clinical parameters. ### Claim 10 (depends on 9) The method of claim 9, wherein the maternal antecedent clinical parameters are one or more from the group consisting of hypertension, anemia, hemoglobinopathies, cardiac dysfunction, and maternal pulmonary disorders. ### Claim 11 (depends on 6) The method of claim 6, wherein the one or more antecedent clinical parameters are fetal antecedent clinical parameters. ### Claim 12 (depends on 11) The method of claim 11, wherein the fetal antecedent clinical parameters are one or more from the group consisting of prematurity, IUGR, meconium passage, placental abruption, multiple gestation, and fetal infection resulting in the fetal inflammatory response syndrome. ### Claim 13 (depends on 6) The method of claim 6, wherein the one or more antecedent clinical parameters are genetic, proteomic, and metabolic markers correlated to a higher risk of neonatal encephalopathy and cerebral palsy. ### Claim 14 (depends on 1) The method of claim 1, wherein the monitoring step further comprises monitoring a patient for one or more of the additional concurrent clinical parameters selected from the group of (f) prolonged latent phase, (g) arrest and protraction of the active phase, (h) failed descent of the presenting part, (i) arrested descent of the presenting part, and (j) protracted descent of the presenting part, and wherein the transforming step comprises transforming the number of the concurrent clinical parameters (a) through (e) that simultaneously, independently exhibit at least one non-reassuring characteristic and the number of the concurrent clinical parameters (f) through (j) that are simultaneously present in the patient into an indication of the present level of risk to the fetus corresponding to the number of the parameters (a) through (e) that simultaneously, independently exhibit at least one non-reassuring characteristic and the number of the concurrent clinical parameters (f) through (j) that are simultaneously present. ### Claim 15 (depends on 14) The method of claim 14, wherein the highest level of risk to the fetus corresponds to any combination of any number of the parameters (a) through (e) that simultaneously, independently exhibit at least one non-reassuring characteristic and any number of the concurrent clinical parameters (f) through (j) that are simultaneously present in the patient which together total six. ### Claim 16 (depends on 14) The method of claim 14, further comprising the step of identifying a predetermined action to be taken in response to the indicated present level of risk to the fetus. ### Claim 17 (depends on 6) The method of claim 6, wherein the monitoring step further comprises monitoring a patient for one or more of the additional concurrent clinical parameters selected from the group of (f) prolonged latent phase, (g) arrest and protraction of the active phase, (h) failed descent of the presenting part, (i) arrested descent of the presenting part, and (j) protracted descent of the presenting part, and wherein the transforming step comprises transforming the number of the concurrent clinical parameters (a) through (e) that simultaneously, independently exhibit at least one non-reassuring characteristic, the number of the concurrent clinical parameters (f) through (j) that are simultaneously present in the patient, and the identified number of one or more antecedent clinical parameters which elevate the level of fetal risk during labor into an indication of the present level of risk to the fetus corresponding to the number of the parameters (a) through (e) that simultaneously, independently exhibit at least one non-reassuring characteristic, the number of the concurrent clinical parameters (f) through (j) that are simultaneously present, and the identified number of one or more antecedent clinical parameters which elevate the level of fetal risk during labor. ### Claim 18 (depends on 17) The method of claim 17, wherein the highest level of risk to the fetus corresponds to any combination of any number of the parameters (a) through (e) that simultaneously, independently exhibit at least one non-reassuring characteristic, any number of the concurrent clinical parameters (f) through (j), and any number of the identified number of one or more antecedent clinical parameters together totaling six. ### Claim 19 (depends on 17) The method of claim 17, further comprising the step of identifying a predetermined action to be taken in response to the indicated present level of risk to the fetus. ### Claim 20 (depends on 17) The method of claim 17, wherein the one or more antecedent clinical parameters are maternal antecedent clinical parameters. ### Claim 21 (depends on 20) The method of claim 20, wherein the maternal antecedent clinical parameters are one or more from the group consisting of hypertension, anemia, hemoglobinopathies, cardiac dysfunction, and maternal pulmonary disorders. ### Claim 22 (depends on 17) The method of claim 17, wherein the one or more antecedent clinical parameters are fetal antecedent clinical parameters. ### Claim 23 (depends on 22) The method of claim 22, wherein the fetal antecedent clinical parameters are one or more from the group consisting of prematurity, IUGR, meconium passage, placental abruption, multiple gestation, and fetal infection resulting in the fetal inflammatory response syndrome. ### Claim 24 (depends on 17) The method of claim 17, wherein the one or more antecedent clinical parameters are genetic, proteomic, and metabolic markers correlated to a higher risk of neonatal encephalopathy and cerebral palsy. ### Claim 25 An apparatus for identifying the level of fetal risk during labor, comprising: at least one computer operative to receive input signals indicative of at least FHR and maternal uterine activity in a patient, the at least one computer further operative to determine from the FHR at least baseline FHR variability, FHR accelerations, and FHR decelerations, to determine when any one or more of at least (a) FHR, (b) baseline FHR variability, (c) FHR accelerations, (d) FHR decelerations, and (e) maternal uterine activity each exhibit at least one non-reassuring characteristic, and to determine a present level of risk to the fetus corresponding to the number of the said parameters (a) through (e) that are simultaneously, independently non-reassuring; and at least one output operatively connected to the at least one computer for indicating the determined present level of risk to the fetus. ### Claim 26 (depends on 25) The apparatus of claim 25, wherein the at least one computer is operative to determine when maternal uterine activity exhibits at least one non-reassuring characteristic independent of fetal response. ### Claim 27 (depends on 26) The apparatus of claim 26, wherein the highest determined level of risk to the fetus corresponds to the simultaneous, independent exhibition of at least one non-reassuring characteristic for each of the parameters (a) through (e). ### Claim 28 (depends on 27) The apparatus of claim 27, wherein the at least one non-reassuring characteristic for each of the parameters (a) through (e) is selected from the following: (a) for FHR: any of (i) a fetal heart rate of over 160 bpm or (i) a fetal heart rate of less than 120 bpm; (b) for baseline FHR variability: any of (i) a variability of more than 15 bpm or (ii) a variability of less than 5 bpm; (c) for FHR accelerations: any of (i) the occurrence of less than two accelerations in 10 minutes of 15 bpm for at least 15 seconds, (ii) the absence of shoulders, or (iii) the presence of overshoots; (d) for FHR decelerations: any of (i) late decelerations, (ii) variable decelerations with slow return to baseline FHR, (iii) the presence of overshoots, or (iv) prolonged FHR deceleration; and (e) for maternal uterine activity: any of (i) repetitive contractions in excess of 5 uterine contractions in 3 consecutive 10 minute windows, (ii) a uterine resting tone of greater than 25 mm Hg, (iii) a contraction duration of greater than 90 seconds, (iv) the coupling or tripling of contractions prior to return to baseline, or (v) a contraction duty cycle of greater than 50%. ### Claim 29 (depends on 25) The apparatus of claim 25, wherein the at least one computer is further operative to identify a predetermined action to be taken in response to the indicated present level of risk to the fetus. ### Claim 30 (depends on 25) The apparatus of claim 25, wherein the at least one computer is further operative to receive user-inputs indicative of the presence in a patient of one or more antecedent clinical parameters which elevate the level of fetal risk during labor, and is operative to determine a present level of risk to the fetus corresponding to the number of the one or more antecedent clinical parameters which elevate the level of fetal risk during labor and the number of the said parameters (a) through (e) that are simultaneously, independently non-reassuring. ### Claim 31 (depends on 30) The apparatus of claim 30, wherein the highest determined level of risk to the fetus corresponds to any combination of any number of the parameters (a) through (e) that simultaneously, independently exhibit at least one non-reassuring characteristic and any number of the identified number of one or more antecedent clinical parameters which together total six. ### Claim 32 (depends on 30) The apparatus of claim 30, wherein the one or more antecedent clinical parameters are maternal antecedent clinical parameters. ### Claim 33 (depends on 32) The apparatus of claim 32, wherein the maternal antecedent clinical parameters are one or more from the group consisting of hypertension, anemia, hemoglobinopathies, cardiac dysfunction, and maternal pulmonary disorders. ### Claim 34 (depends on 30) The apparatus of claim 30, wherein the one or more antecedent clinical parameters are fetal antecedent clinical parameters. ### Claim 35 (depends on 34) The apparatus of claim 34, wherein the fetal antecedent clinical parameters are one or more from the group consisting of prematurity, IUGR, meconium passage, placental abruption, multiple gestation, and fetal infection resulting in the fetal inflammatory response syndrome. ### Claim 36 (depends on 30) The apparatus of claim 30, wherein the one or more antecedent clinical parameters are genetic, proteomic, and metabolic markers correlated to a higher risk of neonatal encephalopathy and cerebral palsy. ### Claim 37 (depends on 30) The apparatus of claim 30, wherein the at least one computer is further operative to identify a predetermined action to be taken in response to the indicated present level of risk to the fetus. ### Claim 38 (depends on 25) The apparatus of claim 25, wherein the at least one computer is further operative to receive user-inputs indicative of the presence in the patient of one or more of the concurrent clinical parameters of (f) prolonged latent phase, (g) arrest and protraction of the active phase, (g) failed descent of the presenting part, (i) arrested descent of the presenting part, and (j) protracted descent of the presenting part, and is further operative to determine a present level of risk to the fetus corresponding to the number of the parameters (a) through (e) that are simultaneously, independently non-reassuring and the number of the concurrent clinical parameters (f) through (j) that are simultaneously present. ### Claim 39 (depends on 38) The apparatus of claim 38, wherein the highest determined level of risk to the fetus corresponds to any combination of any number of the parameters (a) through (e) that simultaneously, independently exhibit at least one non-reassuring characteristic and any number of the concurrent clinical parameters (f) through (j) that are simultaneously present in the patient which together total six. ### Claim 40 (depends on 38) The apparatus of claim 38, wherein the at least one computer is further operative to identify a predetermined action to be taken in response to the indicated present level of risk to the fetus. ### Claim 41 (depends on 30) The apparatus of claim 30, wherein the at least one computer is further operative to receive user-inputs indicative of the presence in the patient of one or more of the concurrent clinical parameters of (f) prolonged latent phase, (g) arrest and protraction of the active phase, (g) failed descent of the presenting part, (i) arrested descent of the presenting part, and (j) protracted descent of the presenting part, and is further operative to determine a present level of risk to the fetus corresponding to the number of the parameters (a) through (e) that are simultaneously, independently non-reassuring, the number of the concurrent clinical parameters (f) through (j) that are simultaneously present, and the number of the one or more antecedent clinical parameters which elevate the level of fetal risk during labor. ### Claim 42 (depends on 41) The apparatus of claim 41, wherein the highest determined level of risk to the fetus corresponds to any combination of any number of the parameters (a) through (e) that simultaneously, independently exhibit at least one non-reassuring characteristic, any number of the concurrent clinical parameters (f) through (j), and any number of the identified number of one or more antecedent clinical parameters totaling six. ### Claim 43 (depends on 41) The apparatus of claim 41, wherein the one or more antecedent clinical parameters are maternal antecedent clinical parameters. ### Claim 44 (depends on 43) The apparatus of claim 43, wherein the maternal antecedent clinical parameters are one or more from the group consisting of hypertension, anemia, hemoglobinopathies, cardiac dysfunction, and maternal pulmonary disorders. ### Claim 45 (depends on 41) The apparatus of claim 41, wherein the one or more antecedent clinical parameters are fetal antecedent clinical parameters. ### Claim 46 (depends on 45) The apparatus of claim 45, wherein the fetal antecedent clinical parameters are one or more from the group consisting of prematurity, IUGR, meconium passage, placental abruption, multiple gestation, and fetal infection resulting in the fetal inflammatory response syndrome. ### Claim 47 (depends on 41) The apparatus of claim 41, wherein the one or more antecedent clinical parameters are genetic, proteomic, and metabolic markers correlated to a higher risk of neonatal encephalopathy and cerebral palsy. ### Claim 48 (depends on 41) The apparatus of claim 41, wherein the at least one computer is further operative to identify a predetermined action to be taken in response to the indicated present level of risk to the fetus.