Clinical Evaluation of the Actim Partus Test

Service: Trial Number:
078-12
Principal Investigator: Conducted at:
Long Beach Memorial, Miller Children‘s Hospital Long Beach
Currently enrolling additional patients:
Yes

The Actim Partus test detects phIGFBP-1, which is a marker of tissue damage that may lead to danger for the fetus and the risk of premature delivery. IGFBP-1 can be found in cervical secretions in the early stages of labor. The primary objective of this study is to the evaluate the performance of the Actim Parvus testin pregnant women between week 21+6 and week 36+6 gestation. The study will be conducted as follows; if the patient meets criteria and agrees to participate in the research; a cervical sample will be collected by a study doctor to evaluate for rupture of fetal membranes (ROM). After the necessary study sample has been collected, each subject will then undergo all clinically indicated diagnostic evaluations for preterm labor. Pregnant women presenting for unplanned obstetrical care and who meet the inclusion criteria available prior to clinically-indicated diagnostic evaluations for preterm labor will be approached for participation into this study.

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