Cardiotocography Combined With ST-analysis Versus Cardiotocography Combined With Scalp-pH in Deliveries With Abnormal CTG - A Randomised Trial
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 1,025
- 试验地点
- 2
- 主要终点
- Frequency of metabolic acidosis in the 2 groups, defined by pH < 7,05 and SBE < -10 in the umbilical artery
研究概览
简要总结
Hypothesis:
STAN monitoring will reduce the number of interventions because of suspected fetal asphyxia and reduce the number of newborns with metabolic acidosis.
Primary endpoint:
- Frequency of metabolic acidosis in the two groups, defined by pH in umbilical cord artery < 7.05 and standard base excess <-10.
Secondary endpoints:
- Number of intervention (VE and caesarean section) in the two groups
- Number of pH measurements in the two groups
- Number of neonates admitted to the neonatal department because of suspected asphyxia in the two groups
The aim of fetal surveillance is to identify those fetuses at risk for developing damage in newborn to term or long term damage caused by lack of oxygen during birth process. Approximately 1/10 of all cases of paralysis due to brain damage (cerebral palsy) is believed to be caused by lack of oxygen during birth. These can be avoided if the investigators intervene actively in the birth before damage occurs.
CardioTocoGraphy (CTG = detection of fetal heart rate pattern and maternal uterine contractions via electrodes on the maternal abdomen and fetal scalp) is a widely used method of fetal surveillance. However, it can be difficult to interpret a CTG, and uncertainty in CTG interpretation may therefore lead to increase in the number of deliveries with vacuum suction and caesarean section. Interpretation of CTG can be improved by analyzing the acidity of a blood sample taken from the skin of the fetal scalp. Such a scalp pH analysis shows indirectly the fetus gets enough oxygen. Scalp pH measurement requires expertise and requires repeated measurements if the abnormal heart rate pattern persists. This method is the normal routine at the maternity ward at Hvidovre Hospital / Roskilde County Hospital.
The problem seems to be partially alleviated by using a newly developed method for fetal surveillance called STAN (ST analysis). By STAN continuously recorded both CTG and fetal ECG (electrocardiography = recording of the electrical heart activity). Simultaneously analyzes a portion of the fetal ECG, namely ST-part because hypoxia leads to changes in it. The technique is easy to use, since it only requires one electrode on the fetal scalp that is placed in the same way as in ordinary CTG registration.
详细描述
The value of STAN (ST analysis) was assessed in 2 randomized trials and shows: 1) A reduction in the incidence of severe hypoxia in fetuses during labor and 2) A reduction in frequency of redemption with suction and caesarean section due to lack of oxygen during the birth process.
Within the last year however, there is substantial new information regarding. STAN. The Swedish Social Board has published a newsletter (17) which describes a possible risk of birth of asphyxiated children, some died and others have cerebral palsy. A new Finnish study (18) suggests that there may be an increased risk of (moderate) acidosis after using STAN.
The above has led to considerable debate, not just in Sweden but also throughout Europe. This has led to the Swedish, Danish (Newsletter 1, Annex 1b) and the common Nordic reference group for STAN orally has announced new clinical guidelines for STAN application. A recently held workshop in Utrecht, Holland will generate joint European guideline, these will be sought published. Against this background it has been necessary to develop new guidelines for the complement of scalp pH in the STAN arm of this project (Annex 1a)
Common to the above studies is that there is consistently applied scalp pH before STAN monitoring begins. It is therefore important to elucidate whether, through the use of STAN monitoring is needed (more than 1) FBS - and if so to what extent FBS is required.
STAN method currently winning widespread in Denmark and internationally (FDA has just approved), notwithstanding that it is not scientifically proven that fetal monitoring with STAN is better than the current monitoring method with scalp pH measurement. It is therefore important to get this resolved in a randomized study in the relative expensive STAN apparatus introduced in several places in Denmark.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •intermediate or abnormal CTG and
- •Normal fetal scalp-pH > or = 7,25
排除标准
- •preterminal CTG
- •Fetal arrythmias or A-V block
- •Severe fetal malformations (known)
- •Amnionitis (temp > 38,5 degr. celcius)
- •maternal Hepatitis B/C or HIV
研究组 & 干预措施
CTG + FBS
intrapartum surveillance with CTG+FBS
干预措施: CTG + FBS (Procedure)
Neoventa S 21 ST-ANalysis of fetal heart
intrapartum surveillance with CTG + STAN
干预措施: Neoventa S 21 ST-ANalysis of fetal heart (Device)
结局指标
主要结局
Frequency of metabolic acidosis in the 2 groups, defined by pH < 7,05 and SBE < -10 in the umbilical artery
时间窗: within 1 hour
We will do a minimum 2 year follow-up on the children
次要结局
- Does STAN reduce number of admissions to NICU and/or HIE(2 years after termination of study)
- Does STAN reduce number of interventions in delivery(vacuum or section)(1 year after termination of study)
研究者
Diana BB Bach, MD
MD
Hvidovre University Hospital