Non-invasive biomarker to identify subject at risk of preterm delivery
AssigneeWinthrop University Hospital
InventorLouis RAGOLIA
Life of this patent
Estimating the term…
Abstract
Methods for diagnosis to allow prediction of the likelihood of preterm birth based upon the concentration of lipocalin-type prostaglandin D2 synthase (L-PGDS) in cervical vaginal secretions. In addition, specific prostaglandin D2 receptor antagonists may represent novel tocolytic therapeutics.
Claims6
1-21. (canceled)
A pharmaceutical formulation comprising a therapeutic amount of a composition selected from the group consisting of at least one of a prostaglandin DP1 receptor antagonist, or a prostaglandin DP2 receptor antagonist, and a selective L-PGDS inhibitor, in an effective and non-teratogenic amount to delay preterm delivery in a pregnant human when administered in repeated doses without harming the fetus.
A method for predicting and delaying preterm delivery of a fetus, comprising:
- collecting a cervical vaginal secretion sample from a pregnant woman having an intact amniotic membrane, with a sponge treated with at least a protease inhibitor and a bacteriocide;
- measuring lipocalin-type prostaglandin D2 synthase concentration and ratios of isoforms of lipocalin-type prostaglandin D2 synthase in the collected cervical vaginal secretion sample;
- determining a likelihood of preterm delivery based on a comparison of the measured lipocalin-type prostaglandin D2 synthase concentration and ratios of the isoforms of lipocalin-type prostaglandin D2 synthase with population statistics with respect to the gestational age of the fetus;
- and
- selectively applying a tocolytic therapy in dependence on the determined likelihood.
A method for delaying preterm delivery of a human fetus, comprising:
- collecting a cervical vaginal secretion sample from a pregnant woman having an intact amniotic membrane;
- employing at least one antibody to measure lipocalin-type prostaglandin D2 synthase concentration and lipocalin-type prostaglandin D2 synthase isoform ratios in the collected cervical vaginal secretion sample;
- comparing the measured lipocalin-type prostaglandin D2 synthase concentration and lipocalin-type prostaglandin D2 synthase isoform ratios in the collected cervical vaginal secretion sample with a relevant standard population, to determine a preterm delivery risk;
- and
- selectively administering a therapeutic amount of at least one composition selected from the group consisting of a prostaglandin DP1 receptor antagonist, a prostaglandin DP2 receptor antagonist, and a selective L-PGDS inhibitor to the pregnant woman dependent on the determined preterm delivery risk.
Dependencies are inferred from the claim text.