L2M Market Assessment Grant: a bioassay to predict birth timing.

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Term delivery in pregnant women occurs over a five-week period from the beginning of the 38th week of gestation to the end of the 42nd week. There are no means to indicate, however, which of these weeks the delivery will actually occur. Our product, a bioassay, is designed to mimic a natural occurrence in the delivery process that determines delivery within 7 days with accuracy >91% and even higher accuracy within 4 days. The principle of the assay is that a chemotactic signal is produced by the fetal membranes (amnion, chorion) surrounding the baby and is released in the final 3-7 days before labour begins. This signal both attracts circulating white blood cells and activates them. The attracted white blood cells will physically migrate into the uterus where they will anchor and then release inflammatory mediators causing the transition from pregnancy to labour and delivery. We can test this with a simple, non-invasive blood draw, which can be obtained at weekly prenatal visits during the final month of pregnancy. Its novelty is it is the only bioassay to assess the timing of birth at term.