Accuracy and cost-analysis of placental alpha-microglobulin-1 test in the diagnosis of premature rupture of fetal membranes in resource-limited community settings

Aim 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