The Performance Characteristics of a Rapid Immunoassay Test in Diagnosing Patients With Prelabour Rupture of Membranes (Prom): a Clinical Cross-sectional Study From September 2022 to November 2022 at Kenyatta National Hospital

Abstract

Background: Prelabour rupture of membranes (PROM), defined as the spontaneous rupture of membranes before the onset of uterine contractions, occurs in 10% of all term and 20–40% of preterm deliveries. Accurately diagnosing PROM is critical because pregnant women may face serious risks, such as chorioamnionitis, premature delivery, cord prolapse, and placental abruption if the diagnosis is missed. On the other hand, over-diagnosis may cause unnecessary and costly interventions, such as hospitalization, tocolysis, labour induction, and corticosteroid and antibiotic administration. The clinical gold standard has been speculum examination for leakage from the cervix or visualization of vaginal pooling. Other tests such as pH determination with nitrazine paper, the ferning tests, and amniotic fluid assessment using sonography are also used in diagnosis. However, these lack satisfactory accuracy to enable a confident diagnosis, especially with equivocal findings. Recently, rapid and straightforward commercially available test strips with supposed high diagnostic accuracy that detect their targeted molecules in cervicovaginal secretions were introduced to resolve this diagnostic issue. Multiple tests exist globally that test for various target molecules present in amniotic fluid, e.g., Actim PROM™ test that detects insulin-like growth factor binding protein (IGFBP-1), Amnisure ROM™ test that detects placental alpha microglobulin-1 (PAMG-1) protein marker, ROM Plus™ that detects alpha-fetoprotein (AFP) and placental protein 12 (PP12, and insulin growth factor binding protein-1). However, none of these is present locally. NADAL PROM™ tests for the detection of insulin-like growth factor binding protein (IGFBP-1) and has recently been introduced locally...