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

作者：Eleje George Uchenna^*; Ezugwu Euzebus Chinonye; Ogunyemi Dotun; Eleje Lydia Ijeoma; Ikechebelu Joseph Ifeanyichukwu; Igwegbe Anthony Osita; Okonkwo John E; Ikpeze Okechukwu Christian; Udigwe Gerald Okanandu; Onah Hyacinth Eze; Nwosu Betrand Obi; Ezeama Chukwuemeka Okwudili; Ezenkwele Eziamaka Pauline

来源：Journal of Obstetrics and Gynaecology Research, 2015, 41(1): 29-38.

DOI：10.1111/jog.12475

• accuracy
• cost
• placental alpha-microglobulin-1
• rupture of membranes
• standard clinical assessment

AimTo determine accuracy and costs of placental -microglobulin-1 (PAMG-1) test compared to standard clinical assessment (SCA) for diagnosing rupture of membranes (ROM).
MethodsA 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 48h to 7days, 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.
ResultsAccuracy, 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 34weeks than 34weeks 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.
ConclusionThis 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.

• 出版日期2015-1