Intrahepatic Cholestasis Of Pregnancy: Clinical Impact Of Ursodeoxycholic Acid Treatment
试验速览
- 阶段
- 3 期
- 状态
- 撤回
- 发起方
- 试验地点
- 7
- 主要终点
- Number of participants with preterm delivery (before week 37)
研究概览
简要总结
The study is a multicenter randomized double blind placebo controlled trial. The study will be conducted on pregnant women with a diagnosis of intrahepatic cholestasis of pregnancy (ICP) in third level hospitals (that are also Academic Hospitals).
Pregnant women at the time of ICP diagnosis will be randomized in two groups:
Group 1 - will receive placebo and obstetrical monitoring until delivery Group 2 - will receive UDCA at the dose of 20 mg/Kg/day and obstetrical monitoring until delivery.
The hypotheses are that UDCA treatment will be superior to placebo and effective in:
reducing the rate of prematurity; improving maternal biochemical parameters and symptoms.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Pregnant state (after week 20 of gestation)
- •Total Serum BA elevation (>10 micromol/l)
- •Transaminases elevation (ALT>40 UI/L and AST>37 UI/L)
- •Occurrence of pruritus
- •Informed consent signed
排除标准
- •Infectious diseases (HBV, HDV, HCV related liver disease, EBV, CMV, HIV infection)
- •Dermatologic diseases
- •Metabolic diseases (including alcohol abuse)
- •Other causes of cholestasis (i.e. PBC; PSC)
- •Autoimmune liver disease
- •Obstructive biliary diseases
- •Drug related pathologies
- •Known or suspected hyper-sensibility to the drug or the pharmacological class under study
- •Serious clinical conditions that, according to the judgment of the investigator, contraindicate the participation to the study (heart, kidney and liver disease)
- •Use of cholestyramine
- •Patients not able or not willing to follow the procedures of the protocol
- •Patients not signing the informed consent
- •Onset of ICP during of after the 36th week of pregnancy
研究组 & 干预措施
Placebo
obstetrical monitoring plus placebo
干预措施: Placebo (Drug)
Ursodeoxycholic acid
obstetrical monitoring plus active drug
干预措施: Ursodeoxycholic Acid (Drug)
结局指标
主要结局
Number of participants with preterm delivery (before week 37)
时间窗: at the time of delivery
次要结局
- Transaminases(from enrolment until delivery)
- APGAR index(1 and 5 minutes after birth)
- Number of pregnancies with Green stained amniotic fluid(at delivery)
- Pruritus on the Visual Analogue Scale(from enrollment until delivery)
- Bile Acids(from enrolment until delivery)
- Fetal movement count(from enrolment until delivery)
- Number of pregnancies with cardiotocography suggestive of fetal stress(from enrolment until delivery)
研究者
Francesco Azzaroli
Assistant Professor
University of Bologna