FGR 中心宫缩描记法的 STV 分析与视觉评估 (SAVEFGR)
胎儿生长受限心宫监护的短期变异分析与视觉评估
This stepped wedge cluster randomized clinical trial investigates whether in pregnant women with severe, early-onset fetal growth restriction, the use of STV analysis in fetal monitoring improves the chances of perinatal survival, compared with visual evaluation of the cardiotocography.
研究概览
详细说明
Severe, early-onset fetal growth restriction (FGR, <32 weeks gestation) is a condition in which the fetus does not reach its growth potential due to placental insufficiency[. This condition affects about 0.3% of pregnancies, accounting for an estimated 15,000 babies in Europe being born premature below 32 weeks gestation. The main clinical dilemma of FGR lies in the timing of birth, given the balance of risks of antenatal mortality and severe damage to organs and the aggravated neonatal effects of prematurity: death or survival with severe neurodevelopmental impairment. The mainstay of clinical management in these cases pivots around the anticipation of the risk of fetal demise from placental oxygenation failure. The monitoring variables that are currently available comprise assessment of the severity of metabolic insufficiency (fetal size and growth, Doppler ultrasound, serum biomarkers) and the early detection of progressive fetal hypoxia with cardiotocography (CTG). The common approach is to deliver the fetus when signs of advanced hypoxia appear on CTG. A delicate balance exists between having the fetus born (too) early and facing the risks of extreme prematurity combined with a very low birthweight; and between delivering the fetus (too) late when the fetus has the disadvantage of hypoxia at birth. The decision when to deliver the fetus, is made mostly based on the CTG. The inter- and intra-observer variability could be overcome by software analysis according to the original Dawes&Redman algorithm. The software calculates the short-term variation (STV) of the inter-beat interval expressed in milliseconds, and a range of secondary calculations. In contrast with repeated decelerations, when fetal hypoxia is considered evident, the place of the software analysis of the fetal heart rate variability is less clear. Although the advantages of mathematized and uniform quantification of the fetal heart rate variability appear self-evident, there are no studies with sufficient power to detect an association of intervention based on STV at any threshold with the most important outcomes: fetal death and long-term infant outcome.
The purpose of this study is to assess the outcomes of monitoring the fetal condition with STV in computerized CTG compared to visual interpretation of the CTG in order to time delivery in pregnant women with severe, early-onset FGR.
研究类型
注册 (估计的)
阶段
- 不适用
联系人和位置
学习联系方式
- 姓名：Wessel Ganzevoort, MD PhD
- 电话号码：003120-5669111
- 邮箱：j.w.ganzevoort@amsterdamumc.nl
研究联系人备份
- 姓名：Anouk Pels, MD PhD
- 电话号码：003120-5669111
- 邮箱：a.pels@amsterdamumc.nl
学习地点
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Amsterdam、荷兰
- 尚未招聘
- Amsterdam University Medical Center
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接触：
- M. E. Bruins
- 电话号码：+3120 566 9111
- 邮箱：m.e.bruins@amsterdamumc.nl
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Maastricht、荷兰
- 尚未招聘
- Maastricht University Medical Center+
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接触：
- M. E. Bruins
- 电话号码：+3120 566 9111
- 邮箱：m.e.bruins@amsterdamumc.nl
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Nijmegen、荷兰
- 尚未招聘
- Radboud University Medical Center
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接触：
- M. E. Bruins
- 电话号码：+3120 566 9111
- 邮箱：m.e.bruins@amsterdamumc.nl
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Rotterdam、荷兰
- 尚未招聘
- Erasmus MC University Medical Center
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接触：
- M. E. Bruins
- 电话号码：+3120 566 9111
- 邮箱：m.e.bruins@amsterdamumc.nl
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Zwolle、荷兰
- 尚未招聘
- Isala
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接触：
- M. E. Bruins
- 电话号码：+3120 566 9111
- 邮箱：m.e.bruins@umcg.nl
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Provincie Groningen
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Groningen、Provincie Groningen、荷兰
- 招聘中
- University Medical Center Groningen
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接触：
- Mariëlle E. Bruins
- 电话号码：+31 50 361 6161
- 邮箱：m.e.bruins@umcg.nl
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Pregnant women with a singleton pregnancy between 24 weeks and 0 days and 31 weeks and 6 days with severe, early-onset fetal growth restriction, admitted in hospital or frequently evaluated ambulatory by CTG (according to local protocol) for fetal monitoring.
- Fetal growth restriction is defined in line with the international Delphi consensus as biometric ultrasound measurement of the abdominal circumference (AC) OR a combination of measurements resulting in an estimated fetal weight (EFW) below the 3rd percentile (<p3) OR a combination of EFW <p10 AND uterine artery pulsatility index (PI) >p95 OR umbilical artery Doppler PI >p95.
- Maternal age ≥ 18 years.
- Able to provide written informed consent for collection and use of data on informed consent form in available language.
Exclusion Criteria:
- Known congenital or chromosomal anomalies influencing perinatal outcome.
- Imminent labour or expected maternal indication for delivery < 48 hours.
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
有源比较器：Visual interpretation of cardiotocography
Monitoring by visual interpretation of cardiotocography |
Visual interpretation of cardiotocography |
|
实验性的：Short term variation
Short term variation by computer software analysis |
Short term variation in computer software analysis |
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Proportion of pregnancies resulting in perinatal death
大体时间：Before discharge from neonatal intensive care unit (NICU), up to 1 year
|
Perinatal death is defined as antenatal death or neonatal/infant death before discharge from NICU |
Before discharge from neonatal intensive care unit (NICU), up to 1 year
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Proportion of children with major neonatal morbidity
大体时间：Before discharge from NICU, up to 1 year
|
Major neonatal morbidity is a composite outcome defined as intraventricular hemorrhage grade 3 or more, periventricular leukomalacia grade 2 or more, moderate or severe bronchopulmonary dysplasia, necrotizing enterocolitis Bell stage 2 or more, or retinopathy of prematurity requiring therapy. |
Before discharge from NICU, up to 1 year
|
|
Proportion of children with neonatal morbidities
大体时间：Before discharge from NICU, up to 1 year
|
Individual neonatal morbidities of the abovementioned composite outcome and additionally persisting ductus arteriosus, persistent pulmonary hypertension of the newborn (PPHN), respiratory distress syndrome (RDS), period of invasive mechanical ventilation in days, medication need, hypoglycaemia, neonatal jaundice, sepsis and cardiovascular function. |
Before discharge from NICU, up to 1 year
|
|
Proportion of children with neurodevelopmental impairment
大体时间：At two years of corrected age
|
Neurodevelopmental impairment is defined as an abnormal test on Bayley III Dutch version (or version IV if available) (composite cognitive score < 85, composite motor score < 85), cerebral palsy, with a Gross Motor Function Classification System (GMFCS) grade > 1, hearing loss needing hearing aids, or severe visual loss (legally certifiable as blind or partially sighted) assessed at two years of corrected age |
At two years of corrected age
|
合作者和调查者
调查人员
- 首席研究员：Wessel Ganzevoort, MD PhD、Amsterdam UMC
出版物和有用的链接
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他相关的 MeSH 术语
其他研究编号
- 84591
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
IPD 计划说明
There is no current plan, but data will be available upon collaboration request
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