ISRCTN91918806已完成3 期
Phase III trial in IntrahepaTic CHolestasis of pregnancy (ICP) to Evaluate urSodeoxycholic acid (UDCA) in improving perinatal outcomes.
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 605
研究概览
简要总结
2018 Protocol article in https://www.ncbi.nlm.nih.gov/pubmed/30482254 protocol 2019 Results article in https://www.ncbi.nlm.nih.gov/pubmed/31378395 results (added 06/08/2019) 2020 Other publications in https://pubmed.ncbi.nlm.nih.gov/33063439/ secondary analysis (added 22/10/2020) 2020 Results article in https://doi.org/10.3310/eme07090 (added 12/09/2023)
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- Female
入选标准
- •1. ICP (pruritus with a raised serum bile acid above the upper limit of normal for the local laboratory)
- •2. 20+0 to 40+6 weeks' gestation on day of randomisation
- •3. No known lethal fetal anomaly
- •4. Singleton or twin pregnancy
- •5. Aged 18 years or over
- •6. Able to give written informed consent
排除标准
- •1. Decision has already made for delivery within the next 48 hours
- •2. Allergy to any component of the UDCA or placebo tablets
- •3. Triplet or higher-order multiple pregnancy
研究者
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