Metformin in Intrahepatic Cholestasis of Pregnancy (METRIC)
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ClinicalTrials.gov Identifier: NCT03056274 |
Recruitment Status : Unknown
Verified January 2018 by Epsom and St Helier University Hospitals NHS Trust.
Recruitment status was: Not yet recruiting
First Posted : February 17, 2017
Last Update Posted : July 26, 2018
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Intrahepatic Cholestases Pregnancy Complications | Drug: Metformin Drug: Ursodeoxycholic Acid | Phase 2 Phase 3 |
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 Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 40 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Single (Participant) |
Primary Purpose: | Treatment |
Official Title: | METformin in Intrahepatic Cholestasis of Pregnancy (METRIC) Study |
Estimated Study Start Date : | January 2019 |
Estimated Primary Completion Date : | June 2019 |
Estimated Study Completion Date : | September 2019 |

Arm | Intervention/treatment |
---|---|
Active Comparator: Metformin arm
Metformin
|
Drug: Ursodeoxycholic Acid
Ursodeoxycholic acid (UDCA) is used to treat gallstones and primary biliary cirrhosis. UDCA is also used to treat obstetric cholestasis (OC), a liver condition that occurs specifically in pregnancy.
Other Name: Destolit®, Urdox®, Ursofalk®, Ursogal® |
Active Comparator: Ursodeoxycholic acid
Ursodeoxycholic acid
|
Drug: Metformin
Metformin Hydrochloride (HCl) Tablets, is an oral antihyperglycemic drug used in the management of type 2 diabetes
Other Name: Glucophage |
- 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
- 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
- Fetal outcomes [ Time Frame: Immediately upon delivery date ]Presence of meconium
- Fetal outcomes [ Time Frame: Immediately upon delivery date ]APGAR score at 5 minutes
- Fetal outcomes [ Time Frame: Immediately upon delivery date ]Umbilical arterial pH at birth
- Maternal outcomes [ Time Frame: From date of randomisation to date of delivery assessed up to 26 weeks ]Symptoms (itch) - assessed by questionnaire at clinic visits
- Maternal outcomes [ Time Frame: From date of randomisation to date of delivery assessed up to 20 weeks ]Maximum dose of medication required
- Maternal outcomes [ Time Frame: From date of randomisation to date of delivery assessed up to 20 weeks ]Gestational diabetes
- Maternal outcomes [ Time Frame: From date of randomisation to date of delivery assessed up to 26 weeks ]Postpartum haemorrhage
- Maternal outcomes [ Time Frame: From date of randomisation to date of delivery assessed up to 20 weeks ]Mode of delivery
- Maternal outcomes [ Time Frame: From date of randomisation to date of delivery assessed up to 26 weeks ]Liver failure

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 20+0 to 40 weeks' gestation on day of randomisation
- Itching with a raised serum bile acid above the upper limit of normal
- Normal anomaly scan at 20 weeks
- Aged 18 years or over
- Able to give written informed consent
- No known pre-existing liver disease
Exclusion Criteria:
- Decision already made for delivery within the next 48 hours
- Known allergy to any component of the ursodeoxycholic acid or metformin tablets
- Patients already on metformin for other conditions

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03056274
Contact: Hassan Shehata, FRCPI, FRCOG | 01372 735735 ext 6887 | hassan.shehata@esth.nhs.uk | |
Contact: Amanda Ali, MRCPI, MRCOG | amandaha.ali@gmail.com |
Principal Investigator: | Hassan Shehata, FRCPI, FRCOG | Epsom & St Helier University Trust |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Epsom and St Helier University Hospitals NHS Trust |
ClinicalTrials.gov Identifier: | NCT03056274 |
Other Study ID Numbers: |
RVR |
First Posted: | February 17, 2017 Key Record Dates |
Last Update Posted: | July 26, 2018 |
Last Verified: | January 2018 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Product Manufactured in and Exported from the U.S.: | No |
Metformin Ursodeoxycholic acid Outcomes |
Cholestasis Cholestasis, Intrahepatic Pregnancy Complications Bile Duct Diseases Biliary Tract Diseases Digestive System Diseases Liver Diseases |
Metformin Ursodeoxycholic Acid Hypoglycemic Agents Physiological Effects of Drugs Cholagogues and Choleretics Gastrointestinal Agents |