跳至主要内容
临床试验/NCT06010238
NCT06010238尚未招募不适用

Short Term Variation Analysis Versus Visual Evaluation of Cardiotocography in Fetal Growth Restriction

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)0 个研究点目标入组 800 人开始时间: 2025年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
800
主要终点
Proportion of pregnancies resulting in perinatal death

研究概览

简要总结

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.

详细描述

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 99 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • 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 >p
  • Maternal age ≥ 18 years.
  • Able to provide written informed consent for collection and use of data on informed consent form in available language.

排除标准

  • Known congenital or chromosomal anomalies influencing perinatal outcome.
  • Imminent labour or expected maternal indication for delivery < 48 hours.

结局指标

主要结局

Proportion of pregnancies resulting in perinatal death

时间窗: 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

次要结局

  • Proportion of children with major neonatal morbidity(Before discharge from NICU, up to 1 year)
  • Proportion of children with neonatal morbidities(Before discharge from NICU, up to 1 year)
  • Proportion of children with neurodevelopmental impairment(At two years of corrected age)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Wessel Ganzevoort

Principal investigator

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

相似试验