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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
Sponsor:
Collaborators:
King's College Hospital NHS Trust
Medway NHS Foundation Trust
Information provided by (Responsible Party):
Epsom and St Helier University Hospitals NHS Trust

Study Description
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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.

Condition or disease Intervention/treatment Phase
Intrahepatic Cholestases Pregnancy Complications Drug: Metformin Drug: Ursodeoxycholic Acid Phase 2 Phase 3

Detailed 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.

Study Design
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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

Resource links provided by the National Library of Medicine


Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. 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

  2. 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


Secondary Outcome Measures :
  1. Fetal outcomes [ Time Frame: From date of randomisation to date of delivery assessed up to 26 weeks ]
    Perinatal death

  2. Fetal outcomes [ Time Frame: From date of randomisation to date of delivery assessed up to 26 weeks ]
    Preterm delivery

  3. Fetal outcomes [ Time Frame: Immediately upon delivery date ]
    Respiratory distress syndrome

  4. Fetal outcomes [ Time Frame: Immediately upon delivery date ]
    Birth weight (g)

  5. Fetal outcomes [ Time Frame: Immediately upon delivery date ]
    Birth weight percentile

  6. Fetal outcomes [ Time Frame: Immediately upon delivery date ]
    Gestational age at delivery


Other Outcome Measures:
  1. Fetal outcomes [ Time Frame: Immediately upon delivery date ]
    Presence of meconium

  2. Fetal outcomes [ Time Frame: Immediately upon delivery date ]
    APGAR score at 5 minutes

  3. Fetal outcomes [ Time Frame: Immediately upon delivery date ]
    Umbilical arterial pH at birth

  4. 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

  5. Maternal outcomes [ Time Frame: From date of randomisation to date of delivery assessed up to 20 weeks ]
    Maximum dose of medication required

  6. Maternal outcomes [ Time Frame: From date of randomisation to date of delivery assessed up to 20 weeks ]
    Gestational diabetes

  7. Maternal outcomes [ Time Frame: From date of randomisation to date of delivery assessed up to 26 weeks ]
    Postpartum haemorrhage

  8. Maternal outcomes [ Time Frame: From date of randomisation to date of delivery assessed up to 20 weeks ]
    Mode of delivery

  9. Maternal outcomes [ Time Frame: From date of randomisation to date of delivery assessed up to 26 weeks ]
    Liver failure


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

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


Contacts
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Contact: Hassan Shehata, FRCPI, FRCOG 01372 735735 ext 6887 hassan.shehata@esth.nhs.uk
Contact: Amanda Ali, MRCPI, MRCOG amandaha.ali@gmail.com

Sponsors and Collaborators
Epsom and St Helier University Hospitals NHS Trust
King's College Hospital NHS Trust
Medway NHS Foundation Trust
Investigators
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Principal Investigator: Hassan Shehata, FRCPI, FRCOG Epsom & St Helier University Trust
More Information
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Publications of Results:

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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

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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
Keywords provided by Epsom and St Helier University Hospitals NHS Trust:
Metformin
Ursodeoxycholic acid
Outcomes
Additional relevant MeSH terms:
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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