Identifying the level of fetal risk during labor

• US 9,131,860 B2
• Filed: 12/29/2008
• Issued: 09/15/2015
• Est. Priority Date: 12/29/2008
• Status: Active Grant

• Current Assignee: Mark Evans
• Original Assignee: Mark Evans
• Inventors: Evans, Mark
• Primary Examiner(s): Koharski, Christopher D
• Assistant Examiner(s): D ABREU, MICHAEL JOSEPH
• Application Number:
  US12/345,090
• Publication Number:
  US 20100168528A1
• Time in Patent Office: 2,451 Days
• Field of Search: 600/511
• US Class Current: 1/1
• 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. 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 fetal heart rate (“

FHR”

) and maternal uterine activity in a patient, the at least one computer further operative (i) to determine from the FHR at least baseline FHR variability, FHR accelerations, and FHR decelerations, and (ii) to determine when each of at least (a) FHR, (b) baseline FHR variability, (c) FHR accelerations, (d) FHR decelerations, and (e) maternal uterine activity exhibit at least one non-reassuring characteristic from among a plurality of pre-defined non-reassuring characteristics for at least the parameters (a) through (e); and

wherein the at least one computer is further operative to (iii) receive user-inputs indicative of the presence in the patient of one or more antecedent clinical parameters which elevate the level of fetal risk during labor, and (iv) to determine at a given point in time during labor a present level of risk to the fetus which takes into account only;

the total number of the one or more antecedent clinical parameters which elevate the level of fetal risk during labor; and

the total number of the parameters (a) through (e) that each simultaneously, independently exhibit at least one of the non-reassuring characteristics at the given point in time during labor;

wherein the at least one computer is further operative to indicate a predetermined action to be taken in response to the present level of risk to the fetus, and wherein further the indicated predetermined action is intervention in labor when the present level of risk to the fetus for an adverse outcome is at a predetermined level; and

at least one output operatively connected to the at least one computer, the at least one output indicating the determined present level of risk to the fetus and the predetermined action to be taken in response to the indicated present level of risk to the fetus.

2. The apparatus of claim 1, wherein the at least one computer is further operative to receive user-inputs indicative of the presence in the patient of the concurrent clinical parameters 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 at least one computer is operative to determine a present level of risk to the fetus corresponding to the total 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.

3. The apparatus of claim 2, wherein the highest determined level of risk to the fetus corresponds to any combination of a number of the parameters (a) through (e) that simultaneously, independently exhibit at least one non-reassuring characteristic and a number of the concurrent clinical parameters (f) through (j) that are simultaneously present in the patient which together total six.

4. The apparatus of claim 2, 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.

5. The apparatus of claim 1, wherein the one or more antecedent clinical parameters are maternal antecedent clinical parameters.

6. The apparatus of claim 5, wherein the maternal antecedent clinical parameters are one or more from the group consisting of hypertension, anemia, hemoglobinopathies, cardiac dysfunction, and maternal pulmonary disorders.

7. The apparatus of claim 1, wherein the one or more antecedent clinical parameters are fetal antecedent clinical parameters.

8. The apparatus of claim 7, 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.

9. The apparatus of claim 1, 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.

10. The apparatus of claim 1, 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 (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%.

11. The apparatus of claim 1, wherein the highest determined level of risk to the fetus corresponds to any combination of a number of the parameters (a) through (e) that simultaneously, independently exhibit at least one non-reassuring characteristic and a number of the identified number of one or more antecedent clinical parameters which together total six.

12. The apparatus of claim 1, 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.

13. 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 fetal heart rate (“

FHR”

) and maternal uterine activity in a patient, the at least one computer further operative (i) to determine from the FHR at least baseline FHR variability, FHR accelerations, and FHR decelerations, and (ii) to determine when each of at least (a) FHR, (b) baseline FHR variability, (c) FHR accelerations, (d) FHR decelerations, and (e) maternal uterine activity exhibit at least one non-reassuring characteristic from among a plurality of pre-defined non-reassuring characteristics for at least the parameters (a) through (e); and

wherein the at least one computer is further operative to (iii) to receive user-inputs indicative of the presence in the patient of the concurrent clinical parameters 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 (iv) to determine at a given point in time during labor a present level of risk to the fetus which takes into account only;

the total of the number of the parameters (a) through (e) that each simultaneously, independently exhibit at least one of the non-reassuring characteristics at the given point in time during labor; and

the number of the concurrent clinical parameters (f) through (j) that are simultaneously present;

wherein the at least one computer is further operative to indicate a predetermined action to be taken in response to the present level of risk to the fetus, and wherein further the indicated predetermined action is intervention in labor when the present level of risk to the fetus for an adverse outcome is at a predetermined level; and

at least one output operatively connected to the at least one computer, the at least one output indicating the determined present level of risk to the fetus and the predetermined action to be taken in response to the indicated present level of risk to the fetus.

14. The apparatus of claim 13, 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 total 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 simultaneously, independently exhibit at least one non-reassuring characteristic.

15. The apparatus of claim 14, wherein the one or more antecedent clinical parameters are maternal antecedent clinical parameters.

16. The apparatus of claim 15, wherein the maternal antecedent clinical parameters are one or more from the group consisting of hypertension, anemia, hemoglobinopathies, cardiac dysfunction, and maternal pulmonary disorders.

17. The apparatus of claim 14, wherein the one or more antecedent clinical parameters are fetal antecedent clinical parameters.

18. The apparatus of claim 17, 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.

19. The apparatus of claim 14, 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.

20. The apparatus of claim 13, wherein the highest determined level of risk to the fetus corresponds to any combination of a number of the parameters (a) through (e) that simultaneously, independently exhibit at least one non-reassuring characteristic and a number of the concurrent clinical parameters (f) through (j) that are simultaneously present in the patient which together total six.

21. The apparatus of claim 20, 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.

22. The apparatus of claim 13, 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.

23. The apparatus of claim 13, 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 (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%.

24. The apparatus of claim 13, 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.

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 fetal heart rate (“

FHR”

) and maternal uterine activity in a patient, the at least one computer further operative;

(i) to determine from the FHR at least baseline FHR variability, FHR accelerations, and FHR decelerations;

(ii) to determine when each of at least (a) FHR, (b) baseline FHR variability, (c) FHR accelerations, (d) FHR decelerations, and (e) maternal uterine activity exhibit at least one non-reassuring characteristic from among a plurality of pre-defined non-reassuring characteristics for at least the parameters (a) through (e), and to assign a pre-defined value to each of said parameters (a) through (e) that simultaneously, independently exhibit at least one of the non-reassuring characteristics; and

(iii) to determine, at a given point in time during labor, a present level of risk to the fetus corresponding only to the total of the values assigned to each of said parameters (a) through (e) at the given point in time; and

wherein the at least one computer is further operative to indicate a predetermined action to be taken in response to the present level of risk to the fetus, and wherein further the indicated predetermined action is intervention in labor when the present level of risk to the fetus for an adverse outcome is at a predetermined level; and

at least one output operatively connected to the at least one computer, the at least one output indicating the determined present level of risk to the fetus and the predetermined action to be taken in response to the indicated present level of risk to the fetus.