ISRCTN76016200进行中（未招募）未知
Perinatal and 2 year neurodevelopmental outcome in late preterm fetal compromise: the TRUFFLE 2 Randomised Trial
适应症
试验速览
- 阶段
- 未知
- 状态
- 进行中（未招募）
- 入组人数
- 638
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- Female
入选标准
- •Current inclusion criteria as of 27/07/2020:
- •All criteria should be fulfilled to be eligible for randomisation:
- •1. Women = 18 years old
- •2. Pregnant with singleton non-anomalous fetuses
- •3. Between 32+0 and 36+6 weeks of gestation
- •4. Estimated fetal weight or abdominal circumference <10th percentile OR decreased by 50 percentiles since an ultrasound scan at 18+0-32+0 weeks
- •5. Cerebral redistribution defined as UCR >1.0 (32+0-33+6 weeks) or >0.8 (34+0-36+6 weeks) measured at least twice in any 24 hours period
- •6. Normal STV on cCTG (4.5 msec or above)
- •Previous inclusion criteria:
- •For screening:
- •1. Women = 18 years old
- •2. Pregnant with singleton fetuses at risk of compromise:
- •2.1 Between 32+0 and 36+6 weeks of gestation and
- •2.2 Estimated fetal weight or abdominal circumference <10th percentile OR abdominal circumference decreased by 50 percentiles from 18-22 week scan
- •For randomisation:
- •3.1 Cerebral redistribution defined as UCR z-score >1.5 (32-33+6 weeks) / >1.0 (34-36+6 weeks) and:
- •3.2 Normal STV on cCTG (> 4.5msec) and:
- •3.3 No contraindications to either trial treatment arm
排除标准
- •Current exclusion criteria as of 27/07/2020:
- •1. Indication for immediate delivery required within 48 hours
- •2. Unable to give informed consent
- •3. Preterm prelabour rupture of the membranes (PPROM)
- •4. Suspected placental abruption or antepartum haemorrhage
- •5. Presence of reversed end diastolic flow in the Umbilical Artery
- •Previous exclusion criteria:
- •1. Indication for immediate delivery within 48 hours
- •2. Unable to give informed consent
- •3. Preterm prelabour rupture of the membranes (PPROM)
- •4. Suspected placental abruption or antepartum haemorrhage
研究者
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