drugset / Trial / NCT03056274
Metformin in Intrahepatic Cholestasis of Pregnancy
Phase 2/3
Unknown
40 enrolled
Epsom and St Helier University Hospitals NHS Trust
King's College Hospital NHS Trust · collabMedway NHS Foundation Trust · collab
RandomizedParallel-groupSingle-blindTreatment
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.
Timeline
- Start
- 2019-01
- Primary completion
- 2019-06
- Completion
- 2019-09
Publications
- Results 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.
- Walker 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.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Metformin | Small molecule | — | Oral |
| Comparator | Ursodeoxycholic Acid | Small molecule | — | — |