Pilot study for a trial of ursodeoxycholic acid (UDCA) and/or early delivery for obstetric cholestasis

niversity of Nottingham (UK)0 个研究点目标入组 125 人开始时间: 2008年7月10日最近更新: 2015年1月13日

适应症

试验速览

暂无简介。

•1. Itching in pregnancy, diagnosed as obstetric cholestasis
•2. 24+0 to 37+6 weeks pregnant; (24+0 - 40+6 weeks) UDCA arm only
•3. Aged 18 - 55 years
•4. Clinician responsible for care is uncertain whether UDCA or early delivery is beneficial
•5. Patients who otherwise fulfil the recruitment criteria, but incidentally have either hepatitis C, or cholelithiasis, or both, are eligible and may be included
•6. Women with multiple pregnancies who are otherwise eligible may be included in the UDCA/placebo comparison only
•7. Willing to participate in the trial and able to give informed consent

•1. Dermatological and allergic pruritus with normal liver biochemistry
•2. Other causes of pruritus and deranged liver enzymes (except hepatitis C and cholelithiasis, see above)
•3. Hepatitis A, hepatitis B, pre-eclampsia, primary hepatic disorders and current medications causing deranged liver enzymes
•4. Women unable or unwilling to consent
•5. Known lethal foetal anomalies
•6. Allergy to any component of the UDCA or placebo capsules

发起方

niversity of Nottingham (UK)