Clinical Trial: Metformin in Intrahepatic Cholestasis of Pregnancy

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional

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

Brief 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.

Detailed Summary:

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.


Sponsor: Epsom and St Helier University Hospitals NHS Trust

Current Primary Outcome:

  • Normalisation of maternal serum concentration of bile salts and liver enzymes [ Time Frame: From date of randomisation to date of delivery assessed up to 26 weeks ]
    Normalisation of Bile acids and liver enzymes - both parameters are the cornerstone for a diagnosis of intrahepatic cholestasis. They have been separated into two outcomes due to to the different laboratory indices of measurement. Results will be aggregated together to report number of patients with abnormal results
  • Normalisation of maternal serum concentration of liver enzymes [ Time Frame: From date of randomisation to date of delivery assessed up to 26 weeks ]
    Normalisation of liver enzymes Alanine transaminase Aspartate transaminase Bilirubin (total) Gamma glutamyl transferase Results will be aggregated together to report the number of patients with abnormal liver enzymes


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Fetal outcomes [ Time Frame: From date of randomisation to date of delivery assessed up to 26 weeks ]
    Perinatal death
  • Fetal outcomes [ Time Frame: From date of randomisation to date of delivery assessed up to 26 weeks ]
    Preterm delivery
  • Fetal outcomes [ Time Frame: Immediately upon delivery date ]
    Respiratory distress syndrome
  • Fetal outcomes [ Time Frame: Immediately upon delivery date ]
    Birth weight (g)
  • Fetal outcomes [ Time Frame: Immediately upon delivery date ]
    Birth weight percentile
  • Fetal outcomes [ Time Frame: Immediately upon delivery date ]
    Gestational age at delivery


Original Secondary Outcome: Same as current

Information By: Epsom and St Helier University Hospitals NHS Trust

Dates:
Date Received: December 22, 2016
Date Started: April 2017
Date Completion: December 2018
Last Updated: February 14, 2017
Last Verified: December 2016