Metformin in Intrahepatic Cholestasis of Pregnancy (METRIC)

Epsom and St Helier University Hospitals NHS Trust

Status and phase: Unknown; Phase 3; Phase 2

Conditions: Pregnancy Complications; Intrahepatic Cholestases

Treatments: Drug: Metformin; Drug: Ursodeoxycholic Acid

Study type: Interventional

Funder types: Other

Identifiers

NCT03056274

RVR

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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40 participants in 2 patient groups

Metformin arm

Active Comparator group

Description:

Metformin

Treatment:

Drug: Ursodeoxycholic Acid

Ursodeoxycholic acid

Active Comparator group

Description:

Ursodeoxycholic acid

Treatment:

Drug: Metformin