Evidence map›Paper›PMID 33063439›Full record

Trial reportBJOG : an international journal of obstetrics and gynaecology2021

Ursodeoxycholic acid in intrahepatic cholestasis of pregnancy: a secondary analysis of the PITCHES trial.

J Fleminger, P T Seed, A Smith, E Juszczak, P H Dixon, J Chambers, J Dorling, C Williamson, J G Thornton, L C Chappell

Open access · hybridAbstract readMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in BJOG : an international journal of obstetrics and gynaecology, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 20 papers.

0numbers the graph read from it
0cells of the map it votes in
20citing papers in PubMed
2.0field-weighted citation impact, top 11% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

20 citing papers in PubMed, 38 citations in OpenAlex.

  1. Trial
  2. Article
  3. Article
  4. Article
  5. Liver Conditions Specific to Pregnancy: Optimizing Management and Outcomes.The Turkish journal of gastroenterology : the official journal of Turkish Society of Gastroenterology · 2026
    Review
  6. Article
  7. Article
  8. Review
  9. Intrahepatic cholestasis of pregnancy.Nature reviews. Disease primers · 2025
    Review
  10. Article
  11. Article
  12. Proteomic Biomarkers of Intrahepatic Cholestasis of Pregnancy.Reproductive sciences (Thousand Oaks, Calif.) · 2024
    Article
  13. Clinical Management Guidelines for Intrahepatic Cholestasis of Pregnancy.Maternal-fetal medicine (Wolters Kluwer Health, Inc.) · 2024
    Article
  14. Article
  15. Review
  16. Article
  17. Article
  18. Article
  19. Article
  20. Redox-Dependent Effects in the Physiopathological Role of Bile Acids.Oxidative medicine and cellular longevity · 2021
    Review
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

10 authors at 5 institutions in 2 countries.

J FlemingerDepartment of Women and Children's Health, School of Life Course Sciences, King's College London, London, UK.ORCID 0000-0002-5744-5137
P T SeedDepartment of Women and Children's Health, School of Life Course Sciences, King's College London, London, UK.ORCID 0000-0001-7904-7933
A SmithNational Perinatal Epidemiology Unit Clinical Trials Unit, Nuffield Department of Population Health, University of Oxford, Oxford, UK.
E JuszczakNational Perinatal Epidemiology Unit Clinical Trials Unit, Nuffield Department of Population Health, University of Oxford, Oxford, UK.
P H DixonDepartment of Women and Children's Health, School of Life Course Sciences, King's College London, London, UK.
J ChambersICP Support, Sutton Coldfield, UK.ORCID 0000-0001-6022-1719
J DorlingDivision of Neonatal-Perinatal Medicine, IWK Health Centre, Halifax, NS, Canada.
C WilliamsonDepartment of Women and Children's Health, School of Life Course Sciences, King's College London, London, UK.
J G ThorntonDivision of Child Health, Obstetrics and Gynaecology, University of Nottingham, Nottingham, UK.ORCID 0000-0001-9764-6876
L C ChappellDepartment of Women and Children's Health, School of Life Course Sciences, King's College London, London, UK.ORCID 0000-0001-6219-3379
King's College London · GBUniversity of Oxford · GBIzaak Walton Killam Health Centre · CAP N Lee Statistics and Computing (United Kingdom) · GBUniversity of Nottingham · GB

Funding

Department of Health 12/164/16Department of Health RP-2014-05-019Efficacy and Mechanism Evaluation Programme 12/164/16
6 · The paper itself

Abstract

objectiveTo evaluate whether a particular group of women with intrahepatic cholestasis of pregnancy (ICP), based on their presenting characteristics, would benefit from treatment with ursodeoxycholic acid (UDCA).

designSecondary analysis of the PITCHES trial (ISRCTN91918806).

settingUnited Kingdom. POPULATION OR SAMPLE: 527 women with ICP.

methodsSubgroup analyses were performed to determine whether baseline bile acid concentrations or baseline itch scores moderated a woman's response to treatment with UDCA.

main outcome measuresBile acid concentration and itch score.

resultsIn women with baseline bile acid concentrations less than 40 μmol/l, treatment with UDCA resulted in increased post-randomisation bile acid concentrations (geometric mean ratio 1.19, 95% CI 1.00-1.41, P = 0.048). A test of interaction showed no significance (P = 0.647). A small, clinically insignificant difference was seen in itch response in women with a high baseline itch score (-6.0 mm, 95% CI -11.80 to -0.21, P = 0.042), with a test of interaction not showing significance (P = 0.640). Further subgroup analyses showed no significance. Across all women there was a weak relationship between bile acid concentrations and itch severity.

conclusionsThere was no subgroup of women with ICP in whom a beneficial effect of treatment with UDCA on bile acid concentration or itch score could be identified. This confirms that its routine use in women with this condition for improvement of bile acid concentration or itch score should be reconsidered. TWEETABLE ABSTRACT: PITCHES: No group of women with ICP has been found in whom UDCA reduces bile acid concentrations or pruritus.

Indexed as

Cholestasis, IntrahepaticPregnancy ComplicationsPruritusUrsodeoxycholic AcidAdultBile Acids and SaltsCholagogues and CholereticsDouble-Blind MethodFemaleHumansOutcome Assessment, Health CarePregnancySeverity of Illness IndexStillbirthSymptom AssessmentUnited KingdomBile Acids and SaltsCholagogues and CholereticsUrsodeoxycholic AcidCholestasisperinatalpregnancystillbirthursodeoxycholic acid

Identifiers

PMID33063439
PMCPMC8246759
OpenAlexW3093098554

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.