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

Conditions: Obstetric cholestasis (OC) is a serious problem in pregnancy. It affects about 1 in 150 pregnancies, about 4500 women per year in the UK. Affected women develop severe itching and sometimes jaundice. More importantly, the condition is associated with increased risks to the unborn baby, premature delivery, and is believed to be an important cause of stillbirth.
MedDRA version: 9.1Level: LLTClassification code 10049055Term: Cholestasis of pregnancy

Registration Number: EUCTR2007-002717-39-GB

Lead Sponsor: niversity of Nottingham

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: Female

Target Recruitment: 200

Inclusion Criteria

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

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.