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Metformin in Intrahepatic Cholestasis of Pregnancy

NCT03056274 · Status: UNKNOWN · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2018-07-26

No results posted yet for this study

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.

Conditions

  • Intrahepatic Cholestases
  • Pregnancy Complications

Interventions

DRUG

Metformin

Metformin Hydrochloride (HCl) Tablets, is an oral antihyperglycemic drug used in the management of type 2 diabetes

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.

Sponsors & Collaborators

  • King's College Hospital NHS Trust

    collaborator OTHER

  • Medway NHS Foundation Trust

    collaborator OTHER

  • Epsom and St Helier University Hospitals NHS Trust

    lead OTHER

Principal Investigators

  • Hassan Shehata, FRCPI, FRCOG · Epsom & St Helier University Trust

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-01-31
Primary Completion
2019-06-30
Completion
2019-09-30

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Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03056274 on ClinicalTrials.gov