Ursodeoxycholic acid versus placebo in women with intrahepatic cholestasis of pregnancy (PITCHES): a randomised controlled trial

Lancet
Lucy C ChappellPITCHES study group

Abstract

Intrahepatic cholestasis of pregnancy, characterised by maternal pruritus and increased serum bile acid concentrations, is associated with increased rates of stillbirth, preterm birth, and neonatal unit admission. Ursodeoxycholic acid is widely used as a treatment without an adequate evidence base. We aimed to evaluate whether ursodeoxycholic acid reduces adverse perinatal outcomes in women with intrahepatic cholestasis of pregnancy. We did a double-blind, multicentre, randomised placebo-controlled trial at 33 hospital maternity units in England and Wales. We recruited women with intrahepatic cholestasis of pregnancy, who were aged 18 years or older and with a gestational age between 20 weeks and 40 weeks and 6 days, with a singleton or twin pregnancy and no known lethal fetal anomaly. Participants were randomly assigned 1:1 to ursodeoxycholic acid or placebo, given as two oral tablets a day at an equivalent dose of 500 mg twice a day. The dose could be increased or decreased at the clinician's discretion, to a maximum of four tablets and a minimum of one tablet a day. We recommended that treatment should be continued from enrolment until the infant's birth. The primary outcome was a composite of perinatal death (in-utero fetal...Continue Reading

Citations

Nov 27, 2019·Clinical Obstetrics and Gynecology·Heather A Frey
Nov 26, 2019·Clinical Obstetrics and Gynecology·Devin D Smith, Kara M Rood
Feb 28, 2020·Drug and Therapeutics Bulletin
Feb 6, 2020·BJOG : an International Journal of Obstetrics and Gynaecology·M CauldwellC Williamson
May 19, 2020·The Journal of Maternal-fetal & Neonatal Medicine : the Official Journal of the European Association of Perinatal Medicine, the Federation of Asia and Oceania Perinatal Societies, the International Society of Perinatal Obstetricians·Songül AlemdaroğluErhan Şimşek
Jan 12, 2020·Hepatology : Official Journal of the American Association for the Study of Liver Diseases·Samar H IbrahimShikha S Sundaram
Jul 28, 2020·The Cochrane Database of Systematic Reviews·Kate F WalkerJim G Thornton
Aug 23, 2019·Nature Reviews. Gastroenterology & Hepatology·Katrina Ray
Sep 25, 2020·American Journal of Perinatology·Casey S YuleDavid B Nelson
Nov 19, 2019·International Journal of Gynaecology and Obstetrics : the Official Organ of the International Federation of Gynaecology and Obstetrics·Michael GearyElizabeth Stringer
May 10, 2020·Journal of Clinical Medicine·Joanna Piechota, Wojciech Jelski
Feb 7, 2020·Hepatology Communications·Carla W Brady
Jul 1, 2020·American Journal of Physiology. Gastrointestinal and Liver Physiology·Vanessa PataiaCatherine Williamson
Sep 19, 2020·Hepatology : Official Journal of the American Association for the Study of Liver Diseases·Monika SarkarNorah A Terrault
Nov 17, 2020·American Journal of Obstetrics and Gynecology·UNKNOWN Society for Maternal-Fetal Medicine (SMFM). Electronic address: pubs@smfm.orgChristian M Pettker
Nov 3, 2020·European Journal of Gastroenterology & Hepatology·Akash RoyRadha Krishna Dhiman
Oct 6, 2020·Mayo Clinic Proceedings·Moira B HilscherJohn E Eaton
Oct 17, 2020·BJOG : an International Journal of Obstetrics and Gynaecology·J FlemingerL C Chappell
Mar 12, 2021·BMJ Case Reports·Amanda Caroline MahleChristopher Novak
Mar 26, 2021·Seminars in Liver Disease·Rebecca Roediger, Jaquelyn Fleckenstein
Feb 16, 2021·BJOG : an International Journal of Obstetrics and Gynaecology·A L MitchellC Williamson
Apr 1, 2021·Diabetic Medicine : a Journal of the British Diabetic Association·Silja M AxelsenJens Fuglsang
Apr 30, 2021·The Lancet. Gastroenterology & Hepatology·Mairead BlackBen W Mol
Apr 30, 2021·The Lancet. Gastroenterology & Hepatology·Caroline OvadiaCatherine Williamson
Apr 27, 2021·Der Gynäkologe·Carsten HagenbeckVerena Keitel
Sep 16, 2020·Journal of Gynecology Obstetrics and Human Reproduction·Agathe DonetJacques Lepercq
May 29, 2021·Biological Chemistry·Christoph G W GertzenLutz Schmitt
Jun 9, 2021·Orphanet Journal of Rare Diseases·Yong ShaoDi Xu
Jun 18, 2021·The Journal of Maternal-fetal & Neonatal Medicine : the Official Journal of the European Association of Perinatal Medicine, the Federation of Asia and Oceania Perinatal Societies, the International Society of Perinatal Obstetricians·Ugo IndraccoloRomolo Di Iorio
Jul 2, 2021·Canadian Journal of Gastroenterology & Hepatology·Jianping XiaoYan Zhang
Aug 17, 2021·Geburtshilfe und Frauenheilkunde·Stanisław M JurkEkkehard Schleussner
Sep 16, 2021·Reproductive Sciences·Antonio F SaadGeorge R Saade
Oct 10, 2021·The Lancet. Gastroenterology & Hepatology·Sushree Monika Sahoo, Soumya Jagannath Mahapatra
Oct 18, 2021·American Journal of Obstetrics & Gynecology MFM·Georgios DoulaverisVincenzo Berghella
Nov 25, 2021·Pathology International·Jacqueline E Birkness-Gartman, Kiyoko Oshima
Dec 1, 2021·Expert Review of Gastroenterology & Hepatology·Shuaijun RenRongrong Xuan

❮ Previous
Next ❯

Software Mentioned

MedSciNet

Related Concepts

Trending Feeds

COVID-19

Coronaviruses encompass a large family of viruses that cause the common cold as well as more serious diseases, such as the ongoing outbreak of coronavirus disease 2019 (COVID-19; formally known as 2019-nCoV). Coronaviruses can spread from animals to humans; symptoms include fever, cough, shortness of breath, and breathing difficulties; in more severe cases, infection can lead to death. This feed covers recent research on COVID-19.

Blastomycosis

Blastomycosis fungal infections spread through inhaling Blastomyces dermatitidis spores. Discover the latest research on blastomycosis fungal infections here.

Nuclear Pore Complex in ALS/FTD

Alterations in nucleocytoplasmic transport, controlled by the nuclear pore complex, may be involved in the pathomechanism underlying multiple neurodegenerative diseases including Amyotrophic Lateral Sclerosis and Frontotemporal Dementia. Here is the latest research on the nuclear pore complex in ALS and FTD.

Applications of Molecular Barcoding

The concept of molecular barcoding is that each original DNA or RNA molecule is attached to a unique sequence barcode. Sequence reads having different barcodes represent different original molecules, while sequence reads having the same barcode are results of PCR duplication from one original molecule. Discover the latest research on molecular barcoding here.

Chronic Fatigue Syndrome

Chronic fatigue syndrome is a disease characterized by unexplained disabling fatigue; the pathology of which is incompletely understood. Discover the latest research on chronic fatigue syndrome here.

Evolution of Pluripotency

Pluripotency refers to the ability of a cell to develop into three primary germ cell layers of the embryo. This feed focuses on the mechanisms that underlie the evolution of pluripotency. Here is the latest research.

Position Effect Variegation

Position Effect Variagation occurs when a gene is inactivated due to its positioning near heterochromatic regions within a chromosome. Discover the latest research on Position Effect Variagation here.

STING Receptor Agonists

Stimulator of IFN genes (STING) are a group of transmembrane proteins that are involved in the induction of type I interferon that is important in the innate immune response. The stimulation of STING has been an active area of research in the treatment of cancer and infectious diseases. Here is the latest research on STING receptor agonists.

Microbicide

Microbicides are products that can be applied to vaginal or rectal mucosal surfaces with the goal of preventing, or at least significantly reducing, the transmission of sexually transmitted infections. Here is the latest research on microbicides.