RESUMO
BACKGROUND: Rupture of membranes (ROM) before the onset of uterine contractions, particularly in pregnancies less than 37 weeks gestational age, is a common diagnostic problem in obstetrical practice. Timely detection of ROM is vital to support gestational age-specific interventions to optimize perinatal outcomes and minimize the risk of serious complications such as preterm delivery, fetal distress and maternal/fetal infections. Rapid bedside immunoassay tests designed to detect amniotic fluid proteins in cervicovaginal fluids have emerged as valuable clinical tools to provide timely ROM diagnosis. METHODS: In this prospective observational study, two commercially-available immunoassay tests (ROM Plus®, AmniSure®) were evaluated concurrently in 111 pregnant women who presented with the chief complaint of ROM. Immunoassay results were compared to clinical parameters for determining ROM via comprehensive, retrospective clinical chart review. Diagnostic performance characteristics were calculated including sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV) and accuracy. RESULTS: Overall, diagnostic performance characteristics were robust and similar between ROM Plus® and AmniSure®, respectively: sensitivity (96.4 and 89.3%), specificity (98.8 and 100%), PPV (96.4 and 100%), NPV (98.8% and 96.5) and accuracy (98.2 and 97.3%). For term patients (≥37 weeks gestation), the sensitivities were 93.8 and 81.3% and specificities were 97.1 and 100% for ROM Plus® and AmniSure®, respectively. For preterm patients (<37 weeks gestation), both immunoassay tests provided exact concordance with clinical confirmation of ROM resulting in 100% diagnostic accuracy. CONCLUSIONS: Both rapid immunoassay tests provided similarly excellent diagnostic accuracy for the rapid detection of ROM with only two discrepant results for ROM Plus® and three discrepant results for AmniSure® compared to clinical confirmation. The findings from this study recommend these tests for pregnant women presenting with suspected ROM to guide correct clinical management decisions to improve obstetrical and neonatal outcomes. TRIAL REGISTRATION: ClinicalTrials.gov, NCT02208011 (1 August 2014).
Assuntos
Ruptura Prematura de Membranas Fetais/diagnóstico , Imunoensaio/métodos , Diagnóstico Pré-Natal/métodos , Adulto , Feminino , Idade Gestacional , Humanos , Imunoensaio/normas , Valor Preditivo dos Testes , Gravidez , Diagnóstico Pré-Natal/normas , Estudos Prospectivos , Estudos Retrospectivos , Sensibilidade e Especificidade , Fatores de TempoRESUMO
Objective To describe our hospital's experience following expectant management of previable preterm prelabor rupture of membranes (pPPROM). Study Design Retrospective review of neonatal survival and maternal and neonatal outcomes of pPPROM cases between 2012 and 2019 at a tertiary referral center in South Central Louisiana. Regression analyses were performed to identify predictors of neonatal survival. Results Of 81 cases of pPPROM prior to 23 weeks gestational age (WGA), 23 survived to neonatal intensive care unit discharge (28.3%) with gestational age at rupture ranging from 18 0/7 to 22 6/7 WGA. Increased latency (adjusted odds ratio [aOR] = 1.30, 95% confidence interval [CI] = 1.11, 1.52) and increased gestational age at rupture (aOR = 1.62, 95% CI = 1.19, 2.21) increased the probability of neonatal survival. Antibiotics prior to delivery were associated with increased latency duration (adjusted hazard ratio = 0.55, 95% CI = 0.42, 0.74). Conclusion Neonatal survival rate following pPPROM was 28.3%. Later gestational age at membrane rupture and increased latency periods are associated with increased neonatal survivability. Antibiotic administration following pPPROM increased latency duration.