EUCTR2014-004478-41-GB进行中（未招募）1 期
Phase III trial in IntrahepaTic CHolestasis of pregnancy (ICP) to Evaluate urSodeoxycholic acid (UDCA) in improving perinatal outcomes - PITCHES: Phase III trial of UDCA in ICP: V1
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 605
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
入选标准
- •ICP (pruritus with a raised serum bile acid above the upper limit of normal for the local laboratory)
- •20+0 to 40+6 weeks' gestation on day of randomisation (see note below on gestational age)
- •No known lethal fetal anomaly
- •Singleton or twin pregnancy
- •Aged 18 years or over
- •Able to give written informed consent
- •Determination of gestational age: for all calculations relating to gestational age (eligibility for enrolment, gestational age at delivery), gestational age will be calculated based on the following hierarchical model, as set out in the NICE guidelines for antenatal care:
- •? From crown-rump length measurement on early ultrasound scan between 10+0 weeks and 13+6 weeks
- •? From head circumference on ultrasound scan if crown–rump length is above 84 mm
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 580
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •? Decision has already made for delivery within the next 48 hours
- •? Allergy to any component of the UDCA or placebo tablets
- •? Triplet or higher-order multiple pregnancy
研究者
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