title: Accuracy and cost-analysis of placental alpha-microglobulin-1 test in the diagnosis of premature rupture of fetal membranes in resource-limited community settings.
abstract: OBJECTIVE
  To determine accuracy and costs of placental α-microglobulin-1 (PAMG-1) test compared to standard clinical assessment (SCA) for diagnosing rupture of membranes (ROM).
  
  
  METHODS
  A multicenter double-blind study of consecutive women with symptoms and signs of ROM in Nnamdi Azikiwe University Teaching Hospital, Nnewi and University of Nigeria Teaching Hospital, Enugu, both in south-east Nigeria using SCA for ROM and the PAMG-1 test was done. ROM was diagnosed if two out of three methods from SCA (pooling, positive nitrazine test or ferning) were present and confirmed post-delivery based on presence of any two of these clinical criteria: delivery in 48 h to 7 days, evidence of chorioamnionitis, membranes overtly ruptured at delivery and adverse perinatal outcomes strongly correlated with prolonged PROM. A cost-analysis was also done. The outcome measures included sensitivity, specificity, accuracy and costs for the two tests.
  
  
  RESULTS
  Accuracy, sensitivity and specificity for the PAMG-1 test were 97.2%, 97.4% and 96.7%, higher than for SCA which were 83.7%, 87.9% and 70.5%, respectively (P < 0.001). Accuracy of SCA was higher at less than 34 weeks than 34 weeks or more (88.3% vs 81.4%) while the PAMG-1 test performed equally at both gestational age categories (96.1% vs 97.7%). In women without pooling, accuracy of the PAMG-1 test was 96.7%, while it was 40.0% with SCA. Analysis showed that the overall cost of SCA was 45% higher than the PAMG-1 test.
  
  
  CONCLUSIONS
  This study confirms that the PAMG-1 test has a consistently high diagnostic accuracy at all gestational ages and with equivocal cases of ROM. The PAMG-1 test appears less costly than SCA.
authors.affiliation: Department of Obstetrics and Gynecology, Nnamdi Azikiwe University Teaching Hospital, Nnewi, Nigeria.
authors.forename: George Uchenna
authors.initials: GU
authors.lastname: Eleje
authors.forename: Euzebus Chinonye
authors.initials: EC
authors.lastname: Ezugwu
authors.forename: Dotun
authors.initials: D
authors.lastname: Ogunyemi
authors.forename: Lydia Ijeoma
authors.initials: LI
authors.lastname: Eleje
authors.forename: Joseph Ifeanyichukwu
authors.initials: JI
authors.lastname: Ikechebelu
authors.forename: Anthony Osita
authors.initials: AO
authors.lastname: Igwegbe
authors.forename: John E
authors.initials: JE
authors.lastname: Okonkwo
authors.forename: Okechukwu Christian
authors.initials: OC
authors.lastname: Ikpeze
authors.forename: Gerald Okanandu
authors.initials: GO
authors.lastname: Udigwe
authors.forename: Hyacinth Eze
authors.initials: HE
authors.lastname: Onah
authors.forename: Betrand Obi
authors.initials: BO
authors.lastname: Nwosu
authors.forename: Chukwuemeka Okwudili
authors.initials: CO
authors.lastname: Ezeama
authors.forename: Eziamaka Pauline
authors.initials: EP
authors.lastname: Ezenkwele
mesh_terms: D000293:Adolescent; D000328:Adult; D003365:Costs and Cost Analysis; D003906:Developing Countries; D004311:Double-Blind Method; D005260:Female; D005322:Premature Rupture of Fetal Membranes / Q000175:diagnosis*; D006801:Humans; D007118:Immunoassay / Q000191:economics*; D018970:Insulin-Like Growth Factor Binding Protein 1 / Q000032:analysis*; D011247:Pregnancy; D011446:Prospective Studies; D055815:Young Adult
chemical_list: C032231:IGFBP1 protein, human; D018970:Insulin-Like Growth Factor Binding Protein 1
keywords: accuracy; cost; placental alpha-microglobulin-1; rupture of membranes; standard clinical assessment