Metformin in Intrahepatic Cholestasis of Pregnancy

• Status: Unknown status
• Trial end date: 2019-09-01
• Target enrollment: 0
• Participant gender: Female

Summary

This is a pilot study aimed at comparing the effect of metformin versus ursodeoxycholic acid in women with intrahepatic cholestasis in pregnancy. The study will be conducted in three NHS hospital sites, over an 18 month period.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Epsom and St Helier University Hospitals NHS Trust
• Collaborators: King's College Hospital NHS Trust; Medway NHS Foundation Trust
• Treatments: Metformin; Ursodeoxycholic Acid

Criteria

Inclusion Criteria:

1. 20+0 to 40 weeks' gestation on day of randomisation

2. Itching with a raised serum bile acid above the upper limit of normal

3. Normal anomaly scan at 20 weeks

4. Aged 18 years or over

5. Able to give written informed consent

6. No known pre-existing liver disease

Exclusion Criteria:

1. Decision already made for delivery within the next 48 hours

2. Known allergy to any component of the ursodeoxycholic acid or metformin tablets

3. Patients already on metformin for other conditions