Methods for selecting, developing and improving diagnostic tests for pregnancy-related conditions

A method for assessing the risk of delivery prior to completion of 35 weeks of gestation, comprising assessing a subset of variables containing at least three and up to all of the responses to the following queries:

• Ethnic Origin Caucasian;
• Marital Status living with partner;
• EGA by sonogram;
• EGA at sampling;
• estimated date of delivery by best;
• cervical dilatation (CM);
• parity-preterm;
• vaginal bleeding at time of sampling;
• cervical consistency at time of sampling;
• and
• previous pregnancy without complication, by querying and testing the subject;
• and
• entering the results of the queries and tests into a computer system that comprises a decision-support system that has been trained to assess the the risk of delivery prior to 35 weeks of gestation, and thereby assessing the risk.

A method for assessing the risk of delivery prior to completion of 35 weeks of gestation in a subject comprising:

• (a) querying and examining the subject to collect observation values reflecting presence and absence of specified clinical data factors and storing the observed clinical data factors in storage means of the computer system, the specified clinical data factors comprising at least four up to all of the factors selected from the group consisting of:
• Ethnic Origin Caucasian, Marital Status living with partner, EGA by sonogram, EGA at sampling, estimated date of delivery by best, cervical dilatation (CM), parity-preterm, vaginal bleeding at time of sampling, cervical consistency at time of sampling, and previous pregnancy without complication;
• (b) applying the observation values from the memory means to a first computer-based decision-support system trained on samples of the specified factors;
• and thereupon
• (c) extracting from the first decision-support system an output value, wherein the output value is a quantitative objective aid to assess the risk of delivery prior to 35 weeks of gestation.

In a computer system, a method for assessing the risk of delivery in a subject prior to completion of 35 weeks of gestation, comprising the steps of:

• (a) querying and examining the subject to collect observation values reflecting presence and absence of specified factors and storing the observation factors in storage means of the computer system, the specified factors comprising:
• Ethnic Origin Caucasian, Marital Status living with partner, EGA by sonogram, EGA at sampling, estimated date of delivery by best, cervical dilatation (CM), parity-preterm, vaginal bleeding at time of sampling, cervical consistency at time of sampling, and previous pregnancy without complication;
• (b) testing a patient and obtaining results of the test from the patient, wherein the test detects fetal fibronectin (fFN) in mammalian body tissue and fluid samples, and/or the test determines the level of a local inflammatory product protein in cervico/vaginal samples;
• and/or of a test that assesses estriol or estretol in saliva, wherein the test is performed prior to, during or after step (a);
• (c) applying the observation values and the fFN test results from the memory means to a neural network trained on samples of the specified factors and the test results;
• and thereupon
• (d) extracting from the trained neural network an output value pair, the output value pair being a preliminary indicator for the risk of delivery prior to 35 weeks of gestation.

A method for assessing the risk for delivery in 7 or fewer days, comprising assessing a subset of variables containing at least three up to all of the following variables:

• Ethnic Origin Caucasian;
• Uterine contractions with or without pain;
• Parity-abortions;
• vaginal bleeding at time of sampling;
• uterine contractions per hour;
• and
• No previous pregnancies, by querying and testing the subject;
• and
• entering the results of the queries and tests into a computer system that comprises a decision-support system that has been trained to assess the the risk of delivery within seven days, and thereby assessing the risk.

A method for assessing in a subject the risk for delivery in 7 days or fewer days, comprising:

• (a) querying and examining the subject to collect observation values reflecting presence and absence of specified clinical data factors and storing the observed clinical data factors in storage means of the computer system, the specified clinical data factors comprising at least four up to all of the factors selected from the group consisting of:
• Ethnic Origin Caucasian, Marital Status living with partner, EGA by sonogram, EGA at sampling, estimated date of delivery by best, cervical dilatation (CM), parity-preterm, vaginal bleeding at time of sampling, cervical consistency at time of sampling, and previous pregnancy without complication;
• (b) applying the observation values from the memory means to a first computer-based decision-support system trained on samples of the specified factors;
• and thereupon
• (c) extracting from the first decision-support system an output value, wherein the output value is a quantitative objective aid to assess the risk of delivery prior to 35 weeks of gestation.

In a computer system, a method for assessing the risk for delivery in 7 days or fewer days, comprising the steps of:

• (a) querying and examining the subject to collect observation values reflecting presence and absence of specified factors and storing the observation factors in storage means of the computer system, the specified factors comprising:
• Ethnic Origin Caucasian, Uterine contractions with or without pain, Parity-abortions, vaginal bleeding at time of sampling, uterine contractions per hour, prior to and No previous pregnancies;
• (b) testing a patient and obtaining results of the test from the patient, wherein the test detects fetal fibronectin (fFN) in mammalian body tissue and fluid samples, and/or the test determines the level of a local inflammatory product protein in cervico/vaginal samples;
• and/or of a test that assesses estriol or estretol in saliva, wherein the test is performed prior to, during or after step (a);
• (c) applying the observation values and the fFN test results from the memory means to a second neural network trained on samples of the specified factors and the test results;
• and thereupon
• (d) extracting from the second trained neural network an output value pair, the output value pair being a preliminary indicator for the risk of delivery in 7 days or few days from obtaining the cervico/vaginal sample.

A method for assessing the risk for delivery in 14 or fewer days, comprising assessing a subset of variables containing at least three up to all of the following variables:

• Ethnic Origin Hispanic;
• Marital Status living with partner;
• Uterine contractions with or without pain;
• Cervical dilatation;
• Uterine contractions per hour;
• and
• No previous pregnancies, by querying and testing the subject;
• and
• entering the results of the queries and tests into a computer system that comprises a decision-support system that has been trained to assess the the risk of delivery within fourteen days, and thereby assessing the risk.

A method for assessing in a subject the risk for delivery in 14 days or fewer days, comprising:

• (a) querying and examining the subject to collect observation values reflecting presence and absence of specified clinical data factors and storing the observed clinical data factors in storage means of the computer system, the specified clinical data factors comprising at least four up to all of the factors selected from the group consisting of:
• Ethnic Origin Hispanic, Marital Status living with partner, Uterine contractions with or without pain, cervical dilatation, Uterine contractions per hour, and No previous pregnancies;
• (b) applying the observation values from the memory means to a first decision-support system trained on samples of the specified factors;
• and thereupon
• (c) extracting from the first decision-support system an output value, wherein the output value is a quantitative objective aid to assess the risk of delivery in less than or in 14 days.

In a computer system, a method for assessing the risk for delivery in 14 days or fewer days, comprising the steps of:

• (a) querying and examining the subject to collect observation values reflecting presence and absence of specified factors and storing the observation factors in storage means of the computer system, the specified factors comprising:
• Ethnic Origin Hispanic, Marital Status living with partner, Uterine contractions with or without pain, cervical dilatation, Uterine contractions per hour, and No previous pregnancies;
• (b) testing a patient and obtaining results of the test from the patient, wherein the test detects fetal fibronectin (fFN) in mammalian body tissue and fluid samples, and/or the test determines the level of a local inflammatory product protein in cervico/vaginal samples;
• and/or of a test that assesses estriol or estretol in saliva, wherein the test is performed prior to, during or after step (a);
• (c) applying the observation values and the fFN test results from the memory means to a second neural network trained on samples of the specified factors and the test results;
• and thereupon
• (d) extracting from the second trained neural network an output value pair, the output value pair being a preliminary indicator for the risk of delivery in 14 days or few days from obtaining the cervico/vaginal sample.