MATERNAL SERUM INTERLEUKIN 6 IN PRETERM PREMATURE RUPTURE OF MEMBRANES

早产儿胎膜早破中的母体血清白细胞介素 6

• 批准号: 6112785
• 负责人: AMY P. MURTHA
• 金额: $ 4.09万
• 依托单位: DUKE UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 1998
• 资助国家: 美国
• 起止时间: 1998-12-01 至 1999-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6112785
• 关键词: blood chemistry; clinical research; female; histology; human subject; interleukin 6; pregnancy infection; serology /serodiagnosis

Purpose: Preterm premature rupture of membranes occurs in approximately 2% of all pregnancies and accounts for 20% of perinatal deaths. Complications associated with preterm premature rupture of membranes include preterm labor, maternal and fetal infection and intrauterine death. We hypothesize that a rise in serum Interleukin-6 in patients with preterm premature rupture of membranes without clinical evidence of infection may indicate the onset of intrauterine infection. An elevation in the serum Interleukin-6 levels in these patients may serve as a marker for women with impending intrauterine infection and potential neonatal sepsis. The ability to identify these intrauterine infections early would allow for more prompt initiation of antibiotic therapy and/or delivery, which may result in prevention of adverse neonatal outcome. The study Aims are 1. to examine the relationship between blood Interleukin-6 levels in-patients with preterm premature rupture of membranes and clinical infection, and 2. to determine if elevated serum cytokine levels are predictive of the onset of intrauterine infection prior to clinical symptoms. Methods: Patients entering the Duke University Medical Center prenatal care system will be eligible to enroll in this prospective study. A 5 ml blood sample will be obtained from pregnant patients upon admission to labor and delivery. Patients admitted with preterm premature rupture of membranes will be asked to have daily blood samples drawn. The blood samples will be refrigerated and then centrifuged at 600g for 10 minutes. The serum will be removed and either studied immediately or frozen at -70oC for future evaluation. The fluid analysis will be performed using a specific ELISA technique for the identification of Interleukin-6. Variables for analysis will include gestational age, presence of labor, clinical evidence of infection (including maternal fever, maternal or fetal tachycardia, leukocytosis, and uterine tenderness), maternal blood Interleukin-6 levels, histologic signs of infection present in the placenta after delivery and perinatal outcome. We will correlate maternal Interleukin-6 levels with the onset of labor or clinical signs of infection in-patients being followed with preterm premature rupture of membranes. Results: Thirty two of the thirty five required subjects have been enrolled in the study. Three subjects withdrew from the study leaving 29 subjects available for analysis. Of those subjects available for analysis 74% developed chorioamnionitis by histologic criteria. Maternal serum is currently frozen and will be analyzed at the completion of patient enrollment. Significance: Management of preterm premature rupture of membranes in the absence of labor is often difficult and controversial. Early signs of infection are usually very subtle or absent in most patients. Once an intrauterine infection is present in the setting of preterm premature rupture of membranes, the fetus is at risk of becoming infected. Fetal sepsis may occur resulting in a significant increase in morbidity and mortality. If a rise in Interleukin-6 occurs in the absence of, or prior to the development of clinical symptoms of infection, this would aid physicians in caring for the mothers ad the fetus. Future plans: We plan to complete enrollment in this study.

目的：早产胎膜早破发生在所有妊娠的约2%，占围产期死亡的20%。与早产胎膜早破相关的并发症包括早产、母婴感染和宫内死亡。我们推测，血清白细胞介素-6升高的早产胎膜早破患者没有感染的临床证据可能表明宫内感染的发生。这些患者血清白细胞介素-6水平的升高可能作为即将发生宫内感染和潜在新生儿败血症的妇女的标志物。早期识别这些宫内感染的能力将允许更迅速地开始抗生素治疗和/或分娩，这可能导致预防不良新生儿结局。本研究的目的是1。探讨早产胎膜早破患者血中白细胞介素-6水平与临床感染的关系。以确定升高的血清细胞因子水平是否是在临床症状出现之前发生宫内感染的预测因素。方法：进入杜克大学医学中心产前护理系统的患者将有资格参加这项前瞻性研究。在分娩和分娩时，将从妊娠患者中采集5 ml血样。患有早产胎膜早破的患者将被要求每天抽取血液样本。将血液样本冷藏，然后以600 g离心10分钟。血清将被取出并立即研究或在-70 ℃下冷冻以供将来评估。将使用特异性ELISA技术进行液体分析，以鉴定白细胞介素-6。分析的变量将包括胎龄、分娩的存在、感染的临床证据（包括母体发热、母体或胎儿心动过速、白细胞增多和子宫压痛）、母体血液白细胞介素-6水平、分娩后胎盘中存在的感染的组织学体征和围产期结局。我们将孕妇白细胞介素-6水平与分娩的开始或感染的临床体征相关，这些患者被随访为早产胎膜早破。结果：35例受试者中有32例已入组研究。3例受试者退出研究，剩下29例受试者可用于分析。在可用于分析的受试者中，74%根据组织学标准发生了绒毛膜炎。母体血清目前处于冷冻状态，将在患者入组完成时进行分析。意义：在没有分娩的情况下处理早产胎膜早破往往是困难和有争议的。感染的早期症状通常非常轻微或在大多数患者中不存在。一旦在未足月胎膜早破的情况下出现宫内感染，胎儿就有被感染的危险。胎儿败血症的发生可能导致发病率和死亡率显著增加。如果白细胞介素-6的升高发生在感染的临床症状不存在或出现之前，这将有助于医生照顾母亲和胎儿。未来计划：我们计划完成本研究的入组。