Vaginal fluid creatinine in diagnosing pre-labor rupture of membranes in Vietnam

Abstract

Pre-labor rupture of membranes (PROM) is a common issue in obstetrics that can lead to serious complications. Timely diagnosis is crucial for proper management of PROM. Creatinine concentration in vaginal fluid is a potential candidate for diagnosing PROM in resource constrained environment. This study aims to investigate the usability of creatinine concentration and its optimal cutoff value for diagnosing PROM. We conducted a case-control diagnostic test study at Hung Vuong Maternity Hospital, Vietnam. Pregnant women between 24–42 weeks were enrolled into case and control groups, with a ratio of 1:2. We used sterile speculum examination for fluid leak from cervix, nitrazine test and ferning test are used to determine membrane’s status. Vaginal fluid was collected by injecting sterile saline and later withdrawing. Data was summarized using descriptive statistics, difference between groups was tested using Mann Whitney U test. The cutoff value was determined by receiver operating characteristics (ROC) curve and Youden’s J statistic. Ethics approval was obtained from the local ethics committee, all participants gave written informed consent. We recruited a total of 693 pregnant women into the study – 231 participants in the study group and 462 participants in the control group. The median vaginal fluid creatinine concentration in the study group is significantly higher than those in the control group (0.84 mg/dL versus 0.09 mg/dL, p<0.01). The optimal cutoff for diagnosing PROM was 0.29 mg/dL, providing 93% sensitivity, 97% specificity and 95% accuracy. Vaginal fluid creatinine concentration is a credible indicator for PROM, providing great diagnostic power and high-quality information.