Screening method for identifying women at increased risk for imminent delivery

• US 5,516,702 A
• Filed: 06/29/1994
• Issued: 05/14/1996
• Est. Priority Date: 11/06/1991
• Status: Expired due to Term

• Current Assignee: Cytyc Corporation (Hologic Incorporated)
• Original Assignee: Cytyc Prenatal Products Corp. (Hologic Incorporated)
• Inventors: Casal, David C., Senyei, Andrew E.
• Primary Examiner(s): Parr, Margaret
• Assistant Examiner(s): GRUN, JAMES LESLIE
• Application Number:
  US08/268,210
• Time in Patent Office: 685 Days
• Field of Search: 435/7.1, 435/7.94, 435/7.24, 435/7.92, 436/510, 436/518, 436/536, 436/814, 436/65, 436/86
• US Class Current: 436/510
• CPC Class Codes: G01N 2800/368 Pregnancy complicated by disease or abnormalities of pregnancy, e.g. preeclampsia, preterm labour
• CPC Class Codes: G01N 33/689 related to pregnancy or the gonads
• CPC Class Codes: Y10S 436/814 Pregnancy

Abstract

The present invention provides an early, biochemical indication of increased risk of impending preterm delivery. The method comprises obtaining a cervicovaginal secretion sample from a pregnant patient after week 12 of gestation and determining the level of a local inflammatory product protein in the sample. The presence of an elevated level of the selected protein in the sample indicates an increased risk of delivery. The test is a screening assay that can detect women at risk of imminent delivery, as early as two to three weeks prior to delivery.

Claims

1. A method of screening for an increased risk of impending delivery comprising:

a) obtaining a secretion sample from the vaginal cavity or the cervical canal of a pregnant patient after week 12 of pregnancy; and

b) determining the level of IL-6 in the sample, the presence of an elevated level of IL-6 in the sample indicating an increased risk of impending delivery.

2. The method of claim 1 wherein the sample is obtained from the posterior fornix.

3. The method of claim 1 wherein the sample is obtained from the cervical os.

4. The method of claim 1 wherein the sample obtained from the patient does not have an elevated level of IL-6 and the method further comprises repeating steps (a) and (b) with at least one additional sample obtained from the patient at least two weeks after the sample determined not to have an elevated level of IL-6.

5. The method of claim 3 comprising repeating steps (a) and (b) with secretion samples from the vaginal cavity or the cervical canal of the patient at intervals of 2 to about 4 weeks until the patient delivers or a sample determined to have an elevated level of IL-6 is obtained.

6. The method of claim 1 wherein the sample has an elevated level of IL-6 and the method further comprises performing a second assay, said second assay being an immunoassay, to determine the presence of fetal fibronectin in a secretion sample from the vaginal cavity or the cervical canal of the patient, wherein determination of the presence of fetal fibronectin by said second assay confirms the increased risk of impending delivery.

7. The method of claim 6 wherein the sample assayed for fetal fibronectin does not contain fetal fibronectin and the method further comprises repeating the second assay with at least one additional sample obtained from the patient at least one week after the sample determined not to have an elevated fetal fibronectin level.

8. The method of claim 6 comprising repeating the second assay with secretion samples from the vaginal cavity or the cervical canal of the patient at two week intervals until the patient delivers or a sample determined to have an elevated fetal fibronectin level is obtained.

9. The method of claim 1 wherein step (b) comprises the steps of:

a) contacting the sample with an antibody specific for IL-6 for a time sufficient for antigen-antibody binding; and

b) determining the amount of binding to determine the level of IL-6 in the sample.