Pilot study for obstetric cholestasis trial

Completed

• Conditions: Obstetric cholestasis; Other specified diseases and conditions complicating pregnancy; Pregnancy and Childbirth

• Registration Number: ISRCTN37730443
• Lead Sponsor: niversity of Nottingham (UK)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-07-10
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 125

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified