IDENTIFYING THE LEVEL OF FETAL RISK DURING LABOR

• US 20100168528A1
• Filed: 12/29/2008
• Published: 07/01/2010
• Est. Priority Date: 12/29/2008
• Status: Active Grant

• Current Assignee: Mark Evans
• Original Assignee: Mark Evans
• Inventors: Evans, Mark
• Granted Patent: US 9,131,860 B2
• Time in Patent Office: Days
• US Class Current: 600/301
• CPC Class Codes: A61B 2503/02 Foetus
• CPC Class Codes: A61B 5/02405 Determining heart rate variability
• CPC Class Codes: A61B 5/02411 of foetuses
• CPC Class Codes: A61B 5/1107 Measuring contraction of parts of the body, e.g. organ, muscle apparatus for measuring work or force in general G01L
• CPC Class Codes: A61B 5/4362 Assessing foetal parameters

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

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.

2. 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.

3. 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).

4. 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%.

5. 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.

6. 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.

7. 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.

8. 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.

9. The method of claim 6, wherein the one or more antecedent clinical parameters are maternal antecedent clinical parameters.

10. 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.

11. The method of claim 6, wherein the one or more antecedent clinical parameters are fetal antecedent clinical parameters.

12. 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.

13. 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.

14. 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.

15. 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.

16. 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.

17. 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.

18. 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.

19. 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.

20. The method of claim 17, wherein the one or more antecedent clinical parameters are maternal antecedent clinical parameters.

21. 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.

22. The method of claim 17, wherein the one or more antecedent clinical parameters are fetal antecedent clinical parameters.

23. 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.

24. 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.

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.

26. 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.

27. 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).

28. 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%.

29. 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.

30. 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.

31. 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.

32. The apparatus of claim 30, wherein the one or more antecedent clinical parameters are maternal antecedent clinical parameters.

33. 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.

34. The apparatus of claim 30, wherein the one or more antecedent clinical parameters are fetal antecedent clinical parameters.

35. 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.

36. 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.

37. 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.

38. 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.

39. 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.

40. 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.

41. 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.

42. 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.

43. The apparatus of claim 41, wherein the one or more antecedent clinical parameters are maternal antecedent clinical parameters.

44. 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.

45. The apparatus of claim 41, wherein the one or more antecedent clinical parameters are fetal antecedent clinical parameters.

46. 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.

47. 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.

48. 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.