Method for prediction of premature labor

• US 5,480,776 A
• Filed: 05/12/1994
• Issued: 01/02/1996
• Est. Priority Date: 09/28/1992
• Status: Expired due to Term

• Current Assignee: Cytyc Corporation (Hologic Incorporated)
• Original Assignee: Biex Inc.
• Inventors: Dullien, Vivian K.
• Primary Examiner(s): Scheiner, Toni R.
• Assistant Examiner(s): Grun, James L.
• Application Number:
  US08/242,034
• Time in Patent Office: 600 Days
• Field of Search: 435/7.9, 435/7.93, 436/65, 436/510, 436/814, 436/127, 436/131, 436/164
• US Class Current: 435/7.9
• CPC Class Codes: G01N 33/743 Steroid hormones
• CPC Class Codes: Y10T 436/20 Oxygen containing
• CPC Class Codes: Y10T 436/203332 Hydroxyl containing

Abstract

A method for detecting the onset of labor in a patient, which comprises analyzing a body fluid of the patient for estriol concentration; correlating the concentration with a standard value; and relating a higher concentration of estriol relative to the standard value as an indication of potential onset of pre-term labor. The standard is usually selected from the group consisting of (1) a predetermined range of estriol concentrations for the body fluid in normal pregnant humans at a preselected time relative to normal, full-term delivery, or (2) a previously measured estriol concentration of the same body fluid of the same pregnant human. Use of this method does not require determination of an estriol/progesterone concentration ratio in the body fluid being test.

Claims

1. A method of screening for the potential onset of preterm labor in a pregnant human at 36 weeks gestation or earlier, which comprises:

(a) analyzing a sample body fluid from said pregnant human to determine unconjugated estriol concentration in the body fluid;

(b) correlating said concentration determined in step (a) with

(1) a predetermined standard unconjugated estriol concentration for said body fluid, or

(2) a previously measured unconjugated estriol concentration in said body fluid of said pregnant human to determine a rate of increase in unconjugated estriol concentration in the body fluid of said pregnant human; and

(c) relating a higher concentration of unconjugated estriol in the body fluid of said pregnant human relative to said predetermined standard unconjugated estriol concentration, or relating an elevated rate of increase in unconjugated estriol concentration in the body fluid of said pregnant human as an indication of potential onset of pro-term labor in said pregnant human, wherein said relating does not consider progesterone concentration in said body fluid.

2. The method of claim 1, wherein said body fluid is saliva, plasma, serum, urine, cervical secretion, vaginal secretion, or sweat.

3. The method of claim 2, wherein said body fluid is saliva and said predetermined standard unconjugated estriol concentration is at least 5 nM.

4. The method of claim 2, wherein said body fluid is saliva and said predetermined standard unconjugated estriol concentration is at least 7 nM.

5. The method of claim 1, wherein said concentration determined in step (a) is determined at 30 weeks gestation or earlier and said predetermined standard unconjugated estriol concentration is at least as high as the 95th percentile concentration of unconjugated estriol for said body fluid for a normal pregnancy at 40 weeks gestation.

6. The method of claim 1, wherein said concentration determined in step (a) is determined within one week of the previously measured unconjugated estriol concentration in said body fluid of said pregnant human, and wherein an elevated rate of increase in unconjugated estriol concentration in the body fluid of said pregnant human is indicated when said concentration determined in step (a) exceeds the previously measured unconjugated estriol concentration in said body fluid of said pregnant human by at least 50%.

7. The method of claim 1, wherein said analyzing comprises a non-instrumented enzyme immunoassay for unconjugated estriol.

8. The method of claim 7, wherein said assay produces a color change at a concentration above said predetermined standard unconjugated estriol concentration.

9. A method of screening for the potential onset of preterm labor in a pregnant human at 36 weeks gestation or earlier, which comprises:

(a) analyzing a saliva sample from said pregnant human to determine the estriol concentration in said saliva sample;

(b) correlating said concentration determined in step (a) with

(1) a predetermined standard estriol concentration for saliva, or

(2) a previously measured estriol concentration in saliva of said pregnant human to determine a rate of increase in estriol concentration in saliva of said pregnant human; and

(c) relating a higher concentration of estriol in the saliva sample of said pregnant human relative to said predetermined standard estriol concentration, or relating an elevated rate of increase in estriol concentration in the saliva of said pregnant human, as an indication of potential onset of pre-term labor in said pregnant human, wherein said relating does not consider progesterone concentration in said saliva.