Method for using breath carbon monoxide concentration measurements to detect pregnant women at risk for or experiencing various pathological conditions relating to pregnancy

• US 6,416,479 B1
• Filed: 07/14/2000
• Issued: 07/09/2002
• Est. Priority Date: 07/14/2000
• Status: Expired due to Fees

• Current Assignee: Natus Medical Incorporated
• Original Assignee: Natus Medical Incorporated
• Inventors: Seidman, Daniel
• Primary Examiner(s): Shaver, Kevin
• Assistant Examiner(s): Natnithithadha, Navin
• Application Number:
  US09/616,536
• Time in Patent Office: 725 Days
• Field of Search: 600/529, 600/531, 600/532, 600/533, 600/534, 600/538, 600/535, 600/536, 600/537, 600/539, 600/540, 600/541, 600/542, 600/543
• US Class Current: 600/532
• CPC Class Codes: A61B 5/0836 Measuring rate of CO2 production

Abstract

A non-invasive method for the early detection and assessment of the severity of various pathological conditions in pregnancy including pregnancy-induced hypertension, preeclampsia, premature uterine contractions and intrauterine growth retardation. The carbon monoxide or end-tidal carbon monoxide concentration is measured in a pregnant woman'"'"'s breath and compared to thresholds for determining the likelihood of onset or actual onset of these pathological conditions. The measurements can be made in a clinic, hospital, physician'"'"'s office, or any other location easily accessible to pregnant women using any of a number of devices for measuring breath carbon monoxide. One solution is to measure end-tidal breath carbon monoxide using the Natus® CO-Stat® End Tidal Breath Analyzer, manufactured and sold by Natus Medical Inc. of San Carlos, Calif. This particular device allows an operator to perform non-invasive, simple and rapid, automatic sampling and analysis of end-tidal carbon monoxide in expiratory air without the requirement for laboratory analysis or highly trained personnel. Thus, the method can be employed using a device that does not required laboratory analysis or highly trained personnel, and results in an on-the-spot, immediate determination which is vital for rapid treatment of these serious conditions of pregnancy.

Claims

1. A method of detecting an increased risk of developing pregnancy-induced hypertension in a pregnant woman comprising the steps of:

(a) collecting a breath sample from a pregnant woman;

(b) measuring the carbon monoxide concentration in said breath sample;

(c) comparing said measured concentration to a reference carbon monoxide concentration indicative of pregnancy-induced hypertension; and

(d) determining that there is an increased risk of pregnancy-induced hypertension in response to said measured breath sample being lower than said reference concentration.

2. The method of claim 1 wherein said measured carbon monoxide concentration is an end-tidal carbon monoxide concentration.

3. The method of claim 1 wherein the collecting step further comprises continuously drawing said sample from said pregnant woman'"'"'s breath stream;

and determining the carbon monoxide concentration from said continuously drawn stream.

4. The method of claim 1 further comprising the step of measuring the breath carbon monoxide value of a sample set of women known not to suffer from pregnancy-induced hypertension;

and determining from said sample set reference carbon monoxide values indicative of a lack of pregnancy-induced hypertension.

5. A method of detecting an increased risk of developing preeclampsia in a pregnant woman comprising the steps of:

(a) collecting a breath sample from a pregnant woman;

(b) measuring the carbon monoxide concentration in said breath sample;

(c) comparing said measured concentration to a reference carbon monoxide concentration indicative of preeclampsia; and

(d) determining that there is an increased risk of preeclampsia in response to said measured breath sample being lower than said reference concentration.

6. The method of claim 5 wherein said measured carbon monoxide concentration is an end-tidal carbon monoxide concentration.

7. The method of claim 5 wherein the collecting step further comprises continuously drawing said sample from said pregnant woman'"'"'s breath stream;

and determining the carbon monoxide concentration from said continuously drawn stream.

8. The method of claim 5 further comprising the step of measuring the breath carbon monoxide value of a sample set of women known not to suffer from preeclampsia;

and determining from said sample set reference carbon monoxide values indicative of a lack of preeclampsia.

9. A method of detecting an increased risk of developing the HELLP Syndrome in a pregnant woman comprising the steps of:

(a) collecting a breath sample from a pregnant woman;

(b) measuring the carbon monoxide concentration in said breath sample;

(c) comparing said measured concentration to a reference carbon monoxide concentration indicative of the HELLP Syndrome; and

(d) determining that there is an increased risk of the HELLP Syndrome in response to said measured breath sample being greater than said reference concentration.

10. The method of claim 9 wherein said measured carbon monoxide concentration is an end-tidal carbon monoxide concentration.

11. The method of claim 9 wherein the collecting step further comprises continuously drawing said sample from said pregnant woman'"'"'s breath stream;

and determining the carbon monoxide concentration from said continuously drawn stream.

12. The method of claim 9 further comprising the step of measuring the breath carbon monoxide value of a sample set of women known not to suffer from the HELLP Syndrome;

and determining from said sample set reference carbon monoxide values indicative of a lack of pregnancy-induced hypertension.

13. A method of detecting an increased risk of developing intrauterine growth restriction in a pregnant woman comprising the steps of:

(a) collecting a breath sample from a pregnant woman;

(b) measuring the carbon monoxide concentration in said breath sample;

(c) comparing said measured concentration to a reference carbon monoxide concentration indicative of intrauterine growth restriction; and

(d) determining that there is an increased risk of intrauterine growth restriction in response to said measured breath sample being lower than said reference concentration.

14. The method of claim 13 wherein said measured carbon monoxide concentration is an end-tidal carbon monoxide concentration.

15. The method of claim 13 wherein the collecting step further comprises continuously drawing said sample from said pregnant woman'"'"'s breath stream;

and determining the carbon monoxide concentration from said continuously drawn stream.

16. The method of claim 13 further comprising the step of measuring the breath carbon monoxide value of a sample set of women known not to suffer from intrauterine growth restriction;

and determining from said sample set reference carbon monoxide values indicative of a lack of intrauterine growth restriction.

17. A method of detecting an increased risk of developing an actively laboring myometrium in a pregnant woman comprising the steps of:

(a) collecting a breath sample from a pregnant woman;

(b) measuring the carbon monoxide concentration in said breath sample;

(c) comparing said measured concentration to a reference carbon monoxide concentration indicative of an actively laboring myometrium; and

(d) determining that there is an increased risk of an actively laboring myometrium in response to said measured breath sample being lower than said reference concentration.

18. The method of claim 17 wherein said measured carbon monoxide concentration is an end-tidal carbon monoxide concentration.

19. The method of claim 17 wherein the collecting step further comprises continuously drawing said sample from said pregnant woman'"'"'s breath stream;

and determining the carbon monoxide concentration from said continuously drawn stream.

20. The method of claim 17 further comprising the step of measuring the breath carbon monoxide value of a sample set of women known not to suffer from an actively laboring myometrium;

and determining from said sample set reference carbon monoxide values indicative of a lack of an actively laboring myometrium.

21. A method of detecting an increased risk of developing premature uterine contractions in a pregnant woman comprising the steps of:

(a) collecting a breath sample from a pregnant woman;

(b) measuring the carbon monoxide concentration in said breath sample;

(c) comparing said measured concentration to a reference carbon monoxide concentration indicative of premature uterine contractions; and

(d) determining that there is an increased risk of premature uterine contractions in response to said measured breath sample being lower than said reference concentration.

22. The method of claim 21 wherein said measured carbon monoxide concentration is an end-tidal carbon monoxide concentration.

23. The method of claim 21 wherein the collecting step further comprises continuously drawing said sample from said pregnant woman'"'"'s breath stream;

and determining the carbon monoxide concentration from said continuously drawn stream.

24. The method of claim 21 further comprising the step of measuring the breath carbon monoxide value of a sample set of women known not to suffer from premature uterine contractions;

and determining from said sample set reference carbon monoxide values indicative of a lack of premature uterine contractions.

25. A method of detecting the onset of pregnancy-induced hypertension in a pregnant woman comprising the steps of:

(a) collecting a breath sample from a pregnant woman;

(b) measuring the carbon monoxide concentration in said breath sample;

(c) comparing said measured concentration to a reference carbon monoxide concentration indicative of pregnancy-induced hypertension; and

(d) determining that there is an increased risk of pregnancy-induced hypertension in response to said measured breath sample being lower than said reference concentration.

26. The method of claim 25 wherein said measured carbon monoxide concentration is an end-tidal carbon monoxide concentration.

27. The method of claim 25 wherein the collecting step further comprises continuously drawing said sample from said pregnant woman'"'"'s breath stream;

and determining the carbon monoxide concentration from said continuously drawn stream.

28. The method of claim 25 further comprising the step of measuring the breath carbon monoxide value of a sample set of women known not to suffer from pregnancy-induced hypertension;

and determining from said sample set reference carbon monoxide values indicative of a lack of pregnancy-induced hypertension.

29. A method of detecting the onset of preeclampsia in a pregnant woman comprising the steps of:

(a) collecting a breath sample from a pregnant woman;

(b) measuring the carbon monoxide concentration in said breath sample;

(c) comparing said measured concentration to a reference carbon monoxide concentration indicative of preeclampsia; and

(d) determining that there is an increased risk of preeclampsia in response to said measured breath sample being lower than said reference concentration.

30. The method of claim 29 wherein said measured carbon monoxide concentration is an end-tidal carbon monoxide concentration.

31. The method of claim 29 wherein the collecting step further comprises continuously drawing said sample from said pregnant woman'"'"'s breath stream;

and determining the carbon monoxide concentration from said continuously drawn stream.

32. The method of claim 29 further comprising the step of measuring the breath carbon monoxide value of a sample set of women known not to suffer from preeclampsia;

and determining from said sample set reference carbon monoxide values indicative of a lack of preeclampsia.

33. A method of detecting the onset of the HELLP Syndrome in a pregnant woman comprising the steps of:

(a) collecting a breath sample from a pregnant woman;

(b) measuring the carbon monoxide concentration in said breath sample;

(c) comparing said measured concentration to a reference carbon monoxide concentration indicative of the HELLP Syndrome; and

(d) determining that there is an increased risk of the HELLP Syndrome in response to said measured breath sample being greater than said reference concentration.

34. The method of claim 33 wherein said measured carbon monoxide concentration is an end-tidal carbon monoxide concentration.

35. The method of claim 33 wherein the collecting step further comprises continuously drawing said sample from said pregnant woman'"'"'s breath stream;

and determining the carbon monoxide concentration from said continuously drawn stream.

36. The method of claim 33 further comprising the step of measuring the breath carbon monoxide value of a sample set of women known not to suffer from the HELLP Syndrome;

and determining from said sample set reference carbon monoxide values indicative of a lack of pregnancy-induced hypertension.

37. A method of detecting the onset of intrauterine growth restriction in a pregnant woman comprising the steps of:

(a) collecting a breath sample from a pregnant woman;

(b) measuring the carbon monoxide concentration in said breath sample;

(c) comparing said measured concentration to a reference carbon monoxide concentration indicative of intrauterine growth restriction; and

(d) determining that there is an increased risk of intrauterine growth restriction in response to said measured breath sample being lower than said reference concentration.

38. The method of claim 37 wherein said measured carbon monoxide concentration is an end-tidal carbon monoxide concentration.

39. The method of claim 37 wherein the collecting step further comprises continuously drawing said sample from said pregnant woman'"'"'s breath stream;

and determining the carbon monoxide concentration from said continuously drawn stream.

40. The method of claim 37 further comprising the step of measuring the breath carbon monoxide value of a sample set of women known not to suffer from intrauterine growth restriction;

and determining from said sample set reference carbon monoxide values indicative of a lack of intrauterine growth restriction.

41. A method of detecting the onset of an actively laboring myometrium in a pregnant woman comprising the steps of:

(a) collecting a breath sample from a pregnant woman;

(b) measuring the carbon monoxide concentration in said breath sample;

(c) comparing said measured concentration to a reference carbon monoxide concentration indicative of an actively laboring myometrium; and

(d) determining that there is an increased risk of an actively laboring myometrium in response to said measured breath sample being lower than said reference concentration.

42. The method of claim 41 wherein said measured carbon monoxide concentration is an end-tidal carbon monoxide concentration.

43. The method of claim 41 wherein the collecting step further comprises continuously drawing said sample from said pregnant woman'"'"'s breath stream;

and determining the carbon monoxide concentration from said continuously drawn stream.

44. The method of claim 41 further comprising the step of measuring the breath carbon monoxide value of a sample set of women known not to suffer from an actively laboring myometrium;

and determining from said sample set reference carbon monoxide values indicative of a lack of an actively laboring myometrium.

45. A method of detecting the onset of premature uterine contractions in a pregnant woman comprising the steps of:

(a) collecting a breath sample from a pregnant woman;

(b) measuring the carbon monoxide concentration in said breath sample;

(c) comparing said measured concentration to a reference carbon monoxide concentration indicative of premature uterine contractions; and

(d) determining that there is an increased risk of premature uterine contractions in response to said measured breath sample being lower than said reference concentration.

46. The method of claim 45 wherein said measured carbon monoxide concentration is an end-tidal carbon monoxide concentration.

47. The method of claim 45 wherein the collecting step further comprises continuously drawing said sample from said pregnant woman'"'"'s breath stream;

and determining the carbon monoxide concentration from said continuously drawn stream.

48. The method of claim 45 further comprising the step of measuring the breath carbon monoxide value of a sample set of women known not to suffer from premature uterine contractions;

and determining from said sample set reference carbon monoxide values indicative of a lack of premature uterine contractions.

49. A method of assessing an increased risk of preeclampsia in smokers according to the exposure to active and passive smoke comprising:

(a) collecting a breath sample from a pregnant smoking woman;

(b) measuring the carbon monoxide concentration in said breath sample;

(c) comparing said measured concentration to a reference carbon monoxide concentration indicative of preeclampsia; and

(d) determining that there is an increased risk of preeclampsia in response to said measured breath sample being lower than said reference concentration.

50. A method of assessing an increased risk of pregnancy-induced hypertension in smokers according to the exposure to active and passive smoke comprising:

(a) collecting a breath sample from a pregnant smoking woman;

(b) measuring the carbon monoxide concentration in said breath sample;

(c) comparing said measured concentration to a reference carbon monoxide concentration indicative of pregnancy-induced hypertension; and

(d) determining that there is an increased risk of pregnancy-induced hypertension in response to said measured breath sample being lower than said reference concentration.

51. A method of assessing an increased risk of intrauterine growth restriction in smokers according to the exposure to active and passive smoke comprising:

(a) collecting a breath sample from a pregnant smoking woman;

(b) measuring the carbon monoxide concentration in said breath sample;

(c) comparing said measured concentration to a reference carbon monoxide concentration indicative of intrauterine growth restriction; and

(d) determining that there is an increased risk of intrauterine growth restriction in response to said measured breath sample being lower than said reference concentration.

52. A method of assessing an increased risk of an actively relaxed myometrium in smokers according to the exposure to active and passive smoke comprising:

(a) collecting a breath sample from a pregnant smoking woman;

(b) measuring the carbon monoxide concentration in said breath sample;

(c) comparing said measured concentration to a reference carbon monoxide concentration indicative of an actively relaxed myometrium; and

(d) determining that there is an increased risk of an actively relaxed myometrium in response to said measured breath sample being lower than said reference concentration.

53. A method of assessing an increased risk of the HELLP Syndrome in smokers according to the exposure to active and passive smoke comprising:

(a) collecting a breath sample from a pregnant smoking woman;

(b) measuring the carbon monoxide concentration in said breath sample;

(c) comparing said measured concentration to a reference carbon monoxide concentration indicative of the HELLP Syndrome; and

(d) determining that there is an increased risk of the HELLP Syndrome in response to said measured breath sample being lower than said reference concentration.

54. A method of assessing an increased risk of premature uterine contractions in smokers according to the exposure to active and passive smoke comprising:

(a) collecting a breath sample from a pregnant smoking woman;

(b) measuring the carbon monoxide concentration in said breath sample;

(c) comparing said measured concentration to a reference carbon monoxide concentration indicative of premature uterine contractions; and

(d) determining that there is an increased risk of premature uterine contractions in response to said measured breath sample being lower than said reference concentration.

55. A method of assessing an increased risk of fetal hypoxia in smokers according to the exposure to active and passive smoke comprising:

(a) collecting a breath sample from a pregnant smoking woman;

(b) measuring the carbon monoxide concentration in said breath sample;

(c) comparing said measured concentration to a reference carbon monoxide concentration indicative of fetal hypoxia; and

(d) determining that there is an increased risk of fetal hypoxia in response to said measured breath sample being lower than said reference concentration.

56. A method of assessing an increased risk of placental abruption in smokers according to the exposure to active and passive smoke comprising:

(a) collecting a breath sample from a pregnant smoking woman;

(b) measuring the carbon monoxide concentration in said breath sample;

(c) comparing said measured concentration to a reference carbon monoxide concentration indicative of placental abruption; and

(d) determining that there is an increased risk of placental abruption in response to said measured breath sample being lower than said reference concentration.