title: Comparison of the duo of insulin-like growth factor binding protein-1/alpha fetoprotein (Amnioquick duo+®) and traditional clinical assessment for diagnosing premature rupture of fetal membranes.
abstract: OBJECTIVE
  To determine the diagnostic accuracy of insulin-like growth factor binding protein-1/alpha fetoprotein (Amnioquick duo+®) compared with traditional clinical assessment (TCA) of nitrazine, ferning and pooling for the diagnosis of prelabor rupture of membranes (PROM).
  
  
  METHODS
  A double-blinded, multicenter clinical study was conducted between February 2015 and August 2015 among pregnant women presenting with symptoms or features suggestive of PROM between 24 and 42 weeks gestation. Confirmation of PROM was done after delivery based on the presence of any two of these criteria: delivery within 48 h to 7 days, evidence of chorioamnionitis, membranes explicitly ruptured at delivery and adverse perinatal outcomes strongly correlated with prolonged PROM. Sensitivity, specificity and accuracy were outcome measures assessed.
  
  
  RESULTS
  Two hundred and thirty-six women were recruited. Three women were excluded from the final analysis due to lack of follow-up data and failure to meet inclusion criteria. Two hundred and thirty-three women had complete data for analysis. The specificity and sensitivity values for TCA were 76.2% and 85.2%, which were lower than those of Amnioquick duo+, which were 97.6% and 97.9%, respectively. The accuracy of Amnioquick duo+ was statistically higher (97.9% vs. 83.7%; RR=1.17; 95%CI=1.10-1.24; P<0.001). In equivocal cases (pooling=negative), the accuracy of Amnioquick duo+ vs. TCA was 98.4% vs. 69.4% (RR=1.42; 95%CI=1.20-1.68; P<0.001) at ≥34 weeks gestation and 100.0% vs. 71.4% (RR=1.40; 95%CI=1.07-1.83; P=0.021) at <34 weeks gestation.
  
  
  CONCLUSIONS
  The performance matrix of Amnioquick duo+® was superior to that of TCA for diagnosing PROM even in equivocal cases.
authors.forename: George Uchenna
authors.initials: GU
authors.lastname: Eleje
authors.forename: Euzebus Chinonye
authors.initials: EC
authors.lastname: Ezugwu
authors.forename: Ahizechukwu Chigoziem
authors.initials: AC
authors.lastname: Eke
authors.forename: Joseph Ifeanyichukwu
authors.initials: JI
authors.lastname: Ikechebelu
authors.forename: Chukwudi Celestine
authors.initials: CC
authors.lastname: Obiora
authors.forename: Nnabuike Okechukwu
authors.initials: NO
authors.lastname: Ojiegbe
authors.forename: Ifeanyichukwu Uzoma
authors.initials: IU
authors.lastname: Ezebialu
authors.forename: Chukwuemeka Okwudili
authors.initials: CO
authors.lastname: Ezeama
authors.forename: Betrand Obi
authors.initials: BO
authors.lastname: Nwosu
authors.forename: Gerald Okanandu
authors.initials: GO
authors.lastname: Udigwe
authors.forename: Charles Ikechukwu
authors.initials: CI
authors.lastname: Okafor
authors.forename: Frank Okechukwu
authors.initials: FO
authors.lastname: Ezugwu
mesh_terms: D000293:Adolescent; D000328:Adult; D004311:Double-Blind Method; D005260:Female; D005322:Premature Rupture of Fetal Membranes / Q000175:diagnosis*; D006801:Humans; D007118:Immunoassay / Q000379:methods / Q000706:statistics & numerical data*; D018970:Insulin-Like Growth Factor Binding Protein 1 / Q000032:analysis*; D011237:Predictive Value of Tests; D011247:Pregnancy; D055815:Young Adult; D000509:alpha-Fetoproteins / Q000032:analysis*
chemical_list: C032231:IGFBP1 protein, human; D018970:Insulin-Like Growth Factor Binding Protein 1; D000509:alpha-Fetoproteins