The disclosure provides biomarker panels, methods and kits for determining the probability for preterm birth in a pregnant female. The present disclosure is based, in part, on the discovery that certain proteins and peptides in biological samples obtained from a pregnant female are differentially expressed in pregnant females that have an increased risk of developing in the future or presently suffering from preterm birth relative to matched controls. The present disclosure is further based, in part, on the unexpected discovery that panels combining one or more of these proteins and peptides can be utilized in methods of determining the probability for preterm birth in a pregnant female with relatively high sensitivity and specificity. These proteins and peptides disclosed herein serve as biomarkers for classifying test samples, predicting a probability of preterm birth, monitoring of progress of preterm birth in a pregnant female, either individually or in a panel of biomarkers.

A computer implemented method of early prediction of risk of pre-eclampsia in a pregnant obese woman is described. The method comprises the steps of inputting abundance values for a panel of obese pregnancy specific metabolite biomarkers obtained from an assayed biological sample into a computational model, in which the biological sample is obtained from an obese pregnant woman at 8 to 24 weeks of pregnancy, and inputting a patient parameter for the pregnant obese woman into the computational model selected from at least one of ethnicity, risk of gestational diabetes, fetal sex, number of pregnancies and level of obesity. The computational model is configured to select a subset comprising at least two of the obese pregnancy specific metabolite biomarkers based on the patient parameter input, correlate abundance values for the subset of obese pregnancy specific metabolite biomarkers with risk of pre-eclampsia, and output a predicted risk of pre-eclampsia for the pregnant obese woman.

The present disclosure relates to methods for predicting time-to-delivery in pregnant women. The methods include predicting that a pregnant woman will deliver within a predetermined time frame if PAMG-1 is determined to be present at a level above a predetermined detection threshold in a vaginal fluid sample obtained from the pregnant woman. Also provided are methods for determining a patient's risk of preterm labor and/or spontaneous rupture of the chorioamniotic membrane.

The present invention relates to biomarker pairs, and particularly, although not exclusively, to pairs of biomarkers that are markers of preterm birth. The biomarker pairs are useful, several weeks or months prior to birth, for distinguishing individuals at risk of experiencing preterm birth.

The subject invention pertains to biomarkers for identifying a subject as having high risk of the development PE. The biomarkers presented herein include miRNAs, post-translational modification of histone proteins, amount, expression and/or activity of histone or DNA modifying enzymes and methylation of sites in the genomic DNA. In certain embodiments, increased miR-17, increased acetylation of H4 histone protein, decreased amount, expression and/or activity of HDACS mRNA or protein or increased methylation of DNA at the genomic site CYP19A1 in the blood, serum or plasma of a subject compared to that of a control subject is used to predict the development of PE in the subject. The invention also provides kits and reagents to conduct assays to quantify biomarkers described herein. The invention further provides the methods of treating and/or managing PE in a subject identified as having a high risk of the development of PE.

A method for treating or inhibiting the progression of placental insufficiency syndrome in a subject in need thereof is provided. The method includes administering to the subject a therapeutically effective amount of a composition including irisin.

An isolated pluripotent trophoblast stem (TS) cell preparation, and methods of preparing the cell preparation and a disease model for a pregnancy related disorder are provided. The cell preparation includes cells that are capable of indefinite proliferation in vitro in an undifferentiated state and capable of differentiation into cells of the trophoblast lineage in vitro or in vivo.

Disclosed herein are methods, kits, tests, and systems for detecting, predicting, monitoring, or ruling out preeclampsia in pregnant women. Also provided herein are novel diagnostic markers, methods of data analysis, assay formats, and kits employing such markers to improve one or more characteristics of a test for identifying or ruling out preeclampsia based on biomarkers from patient samples.

Provided herein are compositions comprising populations of cells obtained from a pregnant subject comprising at least one of a Hofbauer cell, a cytotrophoblast, a syncytiotrophoblast, an extravillous trophoblast, a villous core stroma, or a fetal vascular cell; a stabilization buffer, wherein the stabilization buffer comprises a preservative; and a cellulosic collection device, wherein at least a subset of the population of cells are intact and inviable and methods of making and using such compositions.

Described herein are methods, compositions, kits, and systems for detecting free and bound PlGF, and using detection of such species to distinguish between pregnant women with or without preeclampsia or related conditions.