ACTRN12617001515381招募中2 期
A triple-blind, randomized, parallel-group, placebo controlled trial to assess the impact of maternal antenatal melatonin supplementation on early childhood neurodevelopmental outcomes in the setting of severe preterm fetal growth restriction.
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 336
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Prevention
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 18 Years 至 o limit（—）
- 性别
- Female
入选标准
- •1) Women, with a singleton pregnancy
- •2) Severe fetal growth restriction (FGR), defined as:
- •Estimated fetal weight equal to, or less than, 3rd centile for gestational age according to charts from Mikolajczyk et al (2011) or an estimated fetal weight that is less than the 10th centile (Mikolajcyk et al 2011) in combination with at least one abnormal fetoplacental doppler study, these being:
- •-Uterine artery (raised pulsatility index equal to, or more than, 95th centile)
- •-Umbilical artery (pulsatility index equal to, or more than, 95th centile or absent/reversed end-diastolic flow)
- •-Ductus venosus (abnormal A wave and/or pulsatility index equal to, or more than, 95th centile)
- •3) Gestation: (confirmed) 23+0 to 31+6 weeks’
- •4) Age: 18 years or more
- •5) Understands English
- •Reference: Mikolajczyk, R.T., et al., A global reference for fetal-weight and birthweight percentiles. Lancet, 2011. 377 (9780): pp. 1855-61
排除标准
- •1) A fetus with a known chromosomal, major structural anomaly or non-placental cause of fetal growth restriction
- •2) Pregnancies requiring immediate delivery (eg absent A wave in ductus venosus, preterminal CTG or biophysical profile)
- •3) Co-recruitment in another clinical trial where a pharmaceutical product or nutritional supplement is the trial intervention.
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