Metformin in Intrahepatic Cholestasis of Pregnancy (NCT03056274) | Clinical Trial Compass
UnknownPhase 2/3
Metformin in Intrahepatic Cholestasis of Pregnancy
40 participantsStarted 2019-01
Plain-language 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.
Who can participate
Age range
18 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Normalisation of maternal serum concentration of bile salts and liver enzymes
Timeframe: From date of randomisation to date of delivery assessed up to 26 weeks
2
Normalisation of maternal serum concentration of liver enzymes
Timeframe: From date of randomisation to date of delivery assessed up to 26 weeks
Trial details
NCT IDNCT03056274
SponsorEpsom and St Helier University Hospitals NHS Trust