Association of adverse perinatal outcomes of intrahepatic cholestasis of pregnancy with biochemical markers: results of aggregate and individual patient data meta-analyses.
Abstract | BACKGROUND: METHODS: We did a systematic review by searching PubMed, Web of Science, and Embase databases for studies published from database inception to June 1, 2018, reporting perinatal outcomes for women with intrahepatic cholestasis of pregnancy when serum bile acid concentrations were available. Inclusion criteria were studies defining intrahepatic cholestasis of pregnancy based upon pruritus and elevated serum bile acid concentrations, with or without raised liver aminotransferase concentrations. Eligible studies were case-control, cohort, and population-based studies, and randomised controlled trials, with at least 30 participants, and that reported bile acid concentrations and perinatal outcomes. Studies at potential higher risk of reporter bias were excluded, including case reports, studies not comprising cohorts, or successive cases seen in a unit; we also excluded studies with high risk of bias from groups selected (eg, a subgroup of babies with poor outcomes were explicitly excluded), conference abstracts, and Letters to the Editor without clear peer review. We also included unpublished data from two UK hospitals. We did a random effects meta-analysis to determine risk of adverse perinatal outcomes. Aggregate data for maternal and perinatal outcomes were extracted from case-control studies, and individual patient data (IPD) were requested from study authors for all types of study (as no control group was required for the IPD analysis) to assess associations between biochemical markers and adverse outcomes using logistic and stepwise logistic regression. This study is registered with PROSPERO, number CRD42017069134. FINDINGS: INTERPRETATION: FUNDING: Tommy's, ICP Support, UK National Institute of Health Research, Wellcome Trust, and Genesis Research Trust.
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Authors | Caroline Ovadia, Paul T Seed, Alexandros Sklavounos, Victoria Geenes, Chiara Di Ilio, Jenny Chambers, Katherine Kohari, Yannick Bacq, Nuray Bozkurt, Romana Brun-Furrer, Laura Bull, Maria C Estiú, Monika Grymowicz, Berrin Gunaydin, William M Hague, Christian Haslinger, Yayi Hu, Tetsuya Kawakita, Ayse G Kebapcilar, Levent Kebapcilar, Jūratė Kondrackienė, Maria P H Koster, Aneta Kowalska-Kańka, Limas Kupčinskas, Richard H Lee, Anna Locatelli, Rocio I R Macias, Hanns-Ulrich Marschall, Martijn A Oudijk, Yael Raz, Eli Rimon, Dan Shan, Yong Shao, Rachel Tribe, Valeria Tripodi, Cigdem Yayla Abide, Ilter Yenidede, Jim G Thornton, Lucy C Chappell, Catherine Williamson |
Journal | Lancet (London, England)
(Lancet)
Vol. 393
Issue 10174
Pg. 899-909
(03 02 2019)
ISSN: 1474-547X [Electronic] England |
PMID | 30773280
(Publication Type: Journal Article, Meta-Analysis, Systematic Review)
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Copyright | Copyright © 2019 The Author(s). Published by Elsevier Ltd. This is an Open Access article under the CC BY 4.0 license. Published by Elsevier Ltd.. All rights reserved. |
Chemical References |
- Bile Acids and Salts
- Biomarkers
- Aspartate Aminotransferases
- Alanine Transaminase
- Bilirubin
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Topics |
- Alanine Transaminase
(blood)
- Aspartate Aminotransferases
(blood)
- Bile Acids and Salts
(blood)
- Bilirubin
(blood)
- Biomarkers
(blood)
- Case-Control Studies
- Cholestasis, Intrahepatic
(blood, epidemiology)
- Cohort Studies
- Female
- Humans
- Infant, Newborn
- Perinatal Death
- Pregnancy
- Pregnancy Complications
(blood, epidemiology)
- Premature Birth
(blood, epidemiology)
- ROC Curve
- Randomized Controlled Trials as Topic
- Risk Factors
- Stillbirth
(epidemiology)
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