ACTRN12623000015640招募中3 期
PRECeDe Trial: Prevention of neonatal Respiratory distress with antenatal corticosteroids prior to Elective Caesarean section in women with Diabetes: a Randomised Controlled Trial
适应症
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 2,200
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
- 16 Years 至 o limit（—）
- 性别
- Female
入选标准
- •Women with a singleton or twin pregnancy between 35+0 and 39+6 weeks gestation who have pre-gestational diabetes OR gestational diabetes (diagnosed on a pregnancy 75g Oral glucose tolerance test according to the WHO criteria for gestational diabetes OR the ADIPS revised criteria during the COVID pandemic)
- •plan to give birth by planned caesarean section within the next 7 days.
排除标准
- •Known major fetal anomaly or chromosomal anomaly.
- •Administration of intramuscular antenatal corticosteroids for the purposes of fetal lung maturation at any stage during the current pregnancy.
- •Thrombocytopaenia with a platelet count below 80x109 /litre
- •Hypersensitivity to betamethasone sodium phosphate, betamethasone acetate, or other corticosteroids
- •received any corticosteroids at any time during the pregnancy
- •Systemic fungal infection
- •Contraindication to corticosteroids
- •Previous participation in the PRECeDe trial (in a previous pregnancy). Note that participation in the PRECeDe pilot Trial is not regarded as an exclusion from participation in the current trial).
研究者
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