A Comparison of Placental Alpha Microglobuliun-1 Rapid Immunoassay and Standard Clinical Method For Diagnosis of Premature Rupture of Membranes

Abstract

Background/Objective:

Premature rupture of membranes (PROM) poses significant risk to the wellbeing of a pregnant woman and her fetus; the risk is more when not appropriately diagnosed and managed. The search for accuracy and increased specificity in diagnosis of PROM is an on-going process. The purpose of this study was to determine the accuracy of placental alpha microglobulin-1 (AmniSure ROM®) based test in detecting presence of amniotic fluid in cervico-vaginal secretions compared with standard clinical assessment in diagnosis of PROM in a rural tertiary hospital in South West, Nigeria. AmniSure ROM is a point of care test which is convenient to both the health care provider and patient; thus its use can shorten the turnaround time and improve patient care.

Methodology:

This was a cross-sectional study. All pregnant women with symptoms suggestive of PROM premature over a period of six months at the Federal Teaching Hospital, Ido Ekiti, south-west Nigeria, were recruited and evaluated using the standard clinical evaluation and AmniSure ROM®.

Results:

In all, 64 participants were recruited. Mean maternal age and gestational age at presentation were 29.6 ± 3.4 years and 37.2 ± 2.4 weeks respectively. AmniSure ROM® test was positive in 81.2% of the participants, while standard clinical test was positive in 71.9% of the participants. The two tests were positive in 70.3% of all evaluated participants. The sensitivity of AmniSure ROM in diagnosis of PROM was 97.8% compared to that obtained in standard clinical assessment. The negative predictive value of AmniSure ROM was 91.7%.

Conclusion and Global Health Implications:

Compared to standard clinical assessment, AmniSure ROM test was a more sensitive, rapid and accurate method for confirming the diagnosis of rupture of membrane. Its adoption in routine practice will reduce complications associated with delay and missed diagnosis following use of routine standard clinical assessment alone.