Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Observational
Official Title: Clinical Evaluation of PRO-MComplete as an Aid in Determination of Rupture of Fetal Membranes
Brief Summary:
Premature rupture of membranes refers to the rupture of the fetal membranes prior to the onset of labor. Premature rupture of membranes is associated with a number of neonatal and maternal complications including an increased incidence of perinatal mortality and intra-amniotic infection. There is a need for improved diagnostic testing because of limitations of the current methods.
PRO-MComplete is an immunochromatographic test that detects insulin growth factor binding protein 1 and alpha-fetoprotein in vaginal fluid as an indicator of membrane rupture.