Metformin in Intrahepatic Cholestasis of Pregnancy
METRIC
METformin in Intrahepatic Cholestasis of Pregnancy (METRIC) Study
1 other identifier
interventional
40
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Jan 2019
Shorter than P25 for phase_2
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 22, 2016
CompletedFirst Posted
Study publicly available on registry
February 17, 2017
CompletedStudy Start
First participant enrolled
January 1, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2019
CompletedJuly 26, 2018
January 1, 2018
5 months
December 22, 2016
July 24, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Normalisation of maternal serum concentration of bile salts and liver enzymes
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
From date of randomisation to date of delivery assessed up to 26 weeks
Normalisation of maternal serum concentration of liver enzymes
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
From date of randomisation to date of delivery assessed up to 26 weeks
Secondary Outcomes (6)
Fetal outcomes
From date of randomisation to date of delivery assessed up to 26 weeks
Fetal outcomes
From date of randomisation to date of delivery assessed up to 26 weeks
Fetal outcomes
Immediately upon delivery date
Fetal outcomes
Immediately upon delivery date
Fetal outcomes
Immediately upon delivery date
- +1 more secondary outcomes
Other Outcomes (9)
Fetal outcomes
Immediately upon delivery date
Fetal outcomes
Immediately upon delivery date
Fetal outcomes
Immediately upon delivery date
- +6 more other outcomes
Study Arms (2)
Metformin arm
ACTIVE COMPARATORMetformin
Ursodeoxycholic acid
ACTIVE COMPARATORUrsodeoxycholic acid
Interventions
Metformin Hydrochloride (HCl) Tablets, is an oral antihyperglycemic drug used in the management of type 2 diabetes
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.
Eligibility Criteria
You may qualify if:
- +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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Epsom and St Helier University Hospitals NHS Trustlead
- King's College Hospital NHS Trustcollaborator
- Medway NHS Foundation Trustcollaborator
Related Publications (2)
Elfituri A, Ali A, Shehata H. Managing Recurring Obstetric Cholestasis With Metformin. Obstet Gynecol. 2016 Dec;128(6):1320-1323. doi: 10.1097/AOG.0000000000001748.
PMID: 27824743RESULTWalker KF, Chappell LC, Hague WM, Middleton P, Thornton JG. Pharmacological interventions for treating intrahepatic cholestasis of pregnancy. Cochrane Database Syst Rev. 2020 Jul 27;7(7):CD000493. doi: 10.1002/14651858.CD000493.pub3.
PMID: 32716060DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Hassan Shehata, FRCPI, FRCOG
Epsom & St Helier University Trust
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 22, 2016
First Posted
February 17, 2017
Study Start
January 1, 2019
Primary Completion
June 1, 2019
Study Completion
September 1, 2019
Last Updated
July 26, 2018
Record last verified: 2018-01
Data Sharing
- IPD Sharing
- Will not share