Departmento de Ginecologia e Obstetrícia, Faculdade de Medicina do Porto, Alameda Hernani Monteiro 4200-319 Porto, Portugal.
BMC Pregnancy Childbirth. 2010 Oct 28;10:71. doi: 10.1186/1471-2393-10-71.
Intrapartum fetal hypoxia remains an important cause of death and permanent handicap and in a significant proportion of cases there is evidence of suboptimal care related to fetal surveillance. Cardiotocographic (CTG) monitoring remains the basis of intrapartum surveillance, but its interpretation by healthcare professionals lacks reproducibility and the technology has not been shown to improve clinically important outcomes. The addition of fetal electrocardiogram analysis has increased the potential to avoid adverse outcomes, but CTG interpretation remains its main weakness. A program for computerised analysis of intrapartum fetal signals, incorporating real-time alerts for healthcare professionals, has recently been developed. There is a need to determine whether this technology can result in better perinatal outcomes.
METHODS/DESIGN: This is a multicentre randomised clinical trial. Inclusion criteria are: women aged ≥ 16 years, able to provide written informed consent, singleton pregnancies ≥ 36 weeks, cephalic presentation, no known major fetal malformations, in labour but excluding active second stage, planned for continuous CTG monitoring, and no known contra-indication for vaginal delivery. Eligible women will be randomised using a computer-generated randomisation sequence to one of the two arms: continuous computer analysis of fetal monitoring signals with real-time alerts (intervention arm) or continuous CTG monitoring as previously performed (control arm). Electrocardiographic monitoring and fetal scalp blood sampling will be available in both arms. The primary outcome measure is the incidence of fetal metabolic acidosis (umbilical artery pH < 7.05, BDecf > 12 mmol/L). Secondary outcome measures are: caesarean section and instrumental vaginal delivery rates, use of fetal blood sampling, 5-minute Apgar score < 7, neonatal intensive care unit admission, moderate and severe neonatal encephalopathy with a marker of hypoxia, perinatal death, rate of internal monitoring, tracing quality, and signal loss. Analysis will follow an intention to treat principle. Incidences of primary and secondary outcomes will be compared between groups. Assuming a reduction in metabolic acidosis from 2.8% to 1.8%, using a two-sided test with alpha = 0.05, power = 0.80, and 10% loss to follow-up, 8133 women need to be randomised.
This study will provide evidence of the impact of intrapartum monitoring with computer analysis and real-time alerts on the incidence of adverse perinatal outcomes, intrapartum interventions and signal quality. (Current controlled trials ISRCTN42314164).
产时胎儿缺氧仍然是死亡和永久性残疾的重要原因，在很大比例的病例中，存在与胎儿监测相关的护理不佳的证据。胎心监护（CTG）仍然是产时监测的基础，但医疗保健专业人员对其解读缺乏可重复性，并且该技术并未显示出能改善具有临床重要意义的结局。胎儿心电图分析的增加增加了避免不良结局的可能性，但 CTG 解读仍然是其主要弱点。最近开发了一种用于分析产时胎儿信号的计算机程序，该程序为医疗保健专业人员实时提供警报。需要确定这项技术是否能带来更好的围产结局。
方法/设计：这是一项多中心随机临床试验。纳入标准为：年龄≥16 岁的女性，能够提供书面知情同意书，单胎妊娠≥36 周，头位，无已知严重胎儿畸形，正在分娩但不包括活跃的第二产程，计划进行连续 CTG 监测，且无阴道分娩的已知禁忌证。符合条件的女性将使用计算机生成的随机序列随机分为两组：连续胎儿监测信号的计算机分析与实时警报（干预组）或之前进行的连续 CTG 监测（对照组）。在两个组中都将进行心电图监测和胎儿头皮血样采集。主要结局指标是胎儿代谢性酸中毒的发生率（脐动脉 pH<7.05，BDecf>12mmol/L）。次要结局指标为：剖宫产术和器械性阴道分娩率、胎儿血样采集的使用、5 分钟 Apgar 评分<7、新生儿重症监护病房入院、伴有缺氧标志物的中度和重度新生儿脑病、围产儿死亡、内部监测率、描记质量和信号丢失。分析将遵循意向治疗原则。将比较两组间主要和次要结局的发生率。假设代谢性酸中毒的发生率从 2.8%降低到 1.8%，使用双侧检验，α=0.05，效能=0.80，10%的失访率，需要随机分配 8133 名女性。
本研究将提供产时监测与计算机分析和实时警报对不良围产结局、产时干预和信号质量的影响的证据。（当前的对照试验 ISRCTN42314164）。
