Evaluation of a Novel Diagnostic Kit for the Detection of Placental Alpha-Microglobulin-1 in the Prediction of Preterm Birth in Women Presenting With Signs and Symptoms of Preterm Labor

Currently, the American College of Obstetricians and Gynecologists (ACOG) indicate in their most recent Practice Bulletin on the Management of Preterm Labor that many tests to identify women at risk of preterm birth have been proposed and evaluated; however, only ultrasonography and fetal fibronectin testing have been shown to have benefit. Ultrasonography to determine cervical length, fetal fibronectin testing, or a combination of both may be useful in determining which women are at high risk for preterm delivery. However, their clinical usefulness may rest primarily with their ability to identify women who are least likely to deliver (i.e. their negative predictive value). Therefore, there is an urgent need for a test with a high positive predictive value in order to accurately predict imminent delivery to allow for salutary intervention.

Inclusion Criteria:Patients presenting for emergency obstetrical care at an emergency room or labor & delivery unit with signs, symptoms or complaints suggestive of preterm labor (PTL)Uterine contractions, with or without painIntermittent lower abdominal painDull backachePelvic pressureBleeding during the second or third trimesterMenstrual-like or intestinal cramping, with or without diarrheaPatient is not "feeling right"Gestational age between 200/7 and 366/7Consenting to be part of the trialExclusion Criteria:Presented for regularly scheduled obstetrical care with symptoms< 18 years old and not emancipated consenting minor< 200/7 weeks of gestation or ≥ 37 weeks of gestation cervix length > 30 mmcervical dilatation > 3 centimetersovert rupture of the fetal membranes (ROM) as indicated by visualized leakage of fluid from the cervical osheavy vaginal bleedingreceived tocolytic medications for treatment of threatened preterm delivery prior to collection of the cervicovaginal specimens or cervical length measurementssuspected placenta previacervical cerclage in placea symptom not associated with idiopathic threatened preterm delivery (e.g. trauma)digital exam prior to specimen collection