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

niversity of Nottingham0 个研究点目标入组 200 人开始时间: 2008年1月11日最近更新: 2012年3月19日

试验速览

暂无简介。

•Inclusion criteria
•1.24+0 to 37+6weeks pregnant; (24+0 – 40+6 weeks) UDCA arm only
•2.age 18-55 years
•3.Diagnosed as OC based on history of pruritus in pregnancy and deranged biochemical parameter (random bile acid >14 µmoles/litre or raised ALT over 100 U/L)
•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.
•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
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•Exclusion criteria
•1.Dermatological and allergic causes for pruritus
•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, alpha-1 antitrypsin deficiency and current medications causing deranged liver enzymes.
•4.Women unable or unwilling to consent
•5.Known lethal fetal anomalies.

发起方

niversity of Nottingham