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Metformin in Intrahepatic Cholestasis of Pregnancy — METRIC  

Pregnancy Complications Clinical Trial

Official title:
METformin in Intrahepatic Cholestasis of Pregnancy (METRIC) Study

Clinical Trial 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.

Clinical Trial Description

Intrahepatic cholestasis is a condition that affects pregnant women. It is characterised by itching, usually in the third trimester of pregnancy and is associated with an increase in the liver enzymes and bile salts. This can be associated with maternal and neonatal morbidity, and rarely perinatal mortality.

The investigators propose to assess and compare the effect of Metformin versus Ursodeoxycholic acid on lowering liver enzymes and bile salts, improving maternal morbidity and improving neonatal outcomes.

This study is a pilot study that will be conducted at 3 NHS hospital sites where patients will randomly assigned to receive either Metformin or Ursodeoxycholic acid. There will be 20 patient in each arm. Recruitment will commence in February 2017 and will run for an 18 month period. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03056274
Study type Interventional
Source Epsom and St Helier University Hospitals NHS Trust
Contact Hassan Shehata, FRCPI, FRCOG
Phone 01372 735735
Email hassan.shehata@esth.nhs.uk
Status Not yet recruiting
Phase Phase 2/Phase 3
Start date January 2019
Completion date September 2019
View Details
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