title: Placental α-microglobulin-1 to detect uncertain rupture of membranes in a European cohort of pregnancies.
abstract: OBJECTIVE
  We evaluated the performance of the placental alpha-microglobulin-1 immunoassay (AmniSure(®), AT) in cervicovaginal secretions in patients with uncertain rupture of membranes (ROM) and investigated the influence of the examiners experience.
  
  
  METHODS
  This prospective cohort study was performed in pregnant women (17-42 weeks of gestation) with signs of possible ROM. Evaluation included clinical assessment, examination for cervical leakage, Nitrazine test and measurement of the amniotic fluid index by ultrasound and AT. ROM occurrence was based on review of the medical records after delivery.
  
  
  RESULTS
  199 women were included. AT had a sensitivity of 94.4%; specificity of 98.6%; positive predictive value, 96.2%; negative predictive value, 98.0%. Clinical assessment showed a sensitivity of 72.2%; specificity of 97.8%; positive predictive value, 92.9%; negative predictive value, 90.6%. AT was more sensitive for diagnosing ROM (p = 0.00596) compared to clinical assessment, independent of the examiners experience. Furthermore, the sole use of AT reduced costs by 58.4% compared to clinical assessment.
  
  
  CONCLUSIONS
  AT was more sensitive compared to clinical assessment, independent of the examiners experience and gestational age. Our data extend its use in patients with uncertain ROM. Moreover, AT seems to be a cost-effective approach in the assessment of these patients.
authors.affiliation: Department of Obstetrics and Gynaecology, University Hospital Basel, University of Basel, Spitalstr. 21, 4031, Basel, Switzerland.
authors.forename: Ariane
authors.initials: A
authors.lastname: Birkenmaier
authors.forename: Jean-Jacques
authors.initials: JJ
authors.lastname: Ries
authors.forename: Jens
authors.initials: J
authors.lastname: Kuhle
authors.forename: Nicole
authors.initials: N
authors.lastname: Bürki
authors.forename: Olav
authors.initials: O
authors.lastname: Lapaire
authors.forename: Irene
authors.initials: I
authors.lastname: Hösli
mesh_terms: D000328:Adult; D000510:Alpha-Globulins / Q000032:analysis* / Q000191:economics; D000653:Amniotic Fluid / Q000000981:diagnostic imaging; D005260:Female; D005322:Premature Rupture of Fetal Membranes / Q000175:diagnosis*; D006801:Humans; D007118:Immunoassay; D011237:Predictive Value of Tests; D011247:Pregnancy; D011248:Pregnancy Complications / Q000175:diagnosis / Q000191:economics; D012680:Sensitivity and Specificity; D014463:Ultrasonography; D055815:Young Adult
chemical_list: D000510:Alpha-Globulins; C016001:alpha-1-microglobulin