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1. Association of adverse perinatal outcomes of intrahepatic cholestasis of pregnancy with biochemical markers

Author

Ovadia, C., Seed, P.T. (P.), Sklavounos, A., Geenes, V., Di Illio, C., Chambers, J. (John), Kohari, K., Bacq, Y., Bozkurt, N., Brun-Furrer, R., Bull, I.D. (Ian), Estiu, M.C., Grymowicz, M., Gunaydin, B., Hague, W.M., Haslinger, C., Hu, Y. (Yu), Kawakita, T., Kebapcilar, A.G., Kebapcilar, L., Kondrackiene, J. (Jurate), Koster, M.P.H., Kowalska-Kanka, A., Kupcinskas, L. (Limas), Lee, R.H., Locatelli, A. (Alberta), Macias, R.I.R., Marschall, H.-U., Oudijk, M.A. (Martijn), Raz, Y., Rimon, E., Shan, D., Shao, Y, Tribe, R., Tripodi, V., Abide, C.Y., Yenidede, I., Thornton, J.G. (Jim), Chappell, LC, Williamson, C. (Catherine), Ovadia, C., Seed, P.T. (P.), Sklavounos, A., Geenes, V., Di Illio, C., Chambers, J. (John), Kohari, K., Bacq, Y., Bozkurt, N., Brun-Furrer, R., Bull, I.D. (Ian), Estiu, M.C., Grymowicz, M., Gunaydin, B., Hague, W.M., Haslinger, C., Hu, Y. (Yu), Kawakita, T., Kebapcilar, A.G., Kebapcilar, L., Kondrackiene, J. (Jurate), Koster, M.P.H., Kowalska-Kanka, A., Kupcinskas, L. (Limas), Lee, R.H., Locatelli, A. (Alberta), Macias, R.I.R., Marschall, H.-U., Oudijk, M.A. (Martijn), Raz, Y., Rimon, E., Shan, D., Shao, Y, Tribe, R., Tripodi, V., Abide, C.Y., Yenidede, I., Thornton, J.G. (Jim), Chappell, LC, and Williamson, C. (Catherine)

Abstract

__Background__ Intrahepatic cholestasis of pregnancy is associated with adverse perinatal outcomes, but the association with the concentration of specific biochemical markers is unclear. We aimed to quantify the adverse perinatal effects of intrahepatic cholestasis of pregnancy in women with increased serum bile acid concentrations and determine whether elevated bile acid concentrations were associated with the risk of stillbirth and preterm birth. __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 populationbased 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 logisti

Published
2019
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2. Ursodeoxycholic acid in intrahepatic cholestasis of pregnancy: a systematic review and individual participant data meta-analysis

Author

Agata Majewska, Jessica A Marathe, Jenny Chambers, Romana Brun-Furrer, Ugo Indraccolo, Yue Cui, Stefan C. Kane, George Attilakos, Maria C. Estiú, L.F. Audris Wong, Andrew Shennan, Rachel M. Tribe, Michael J. Peek, Richard H. Lee, Keren Zloto, Jim G Thornton, Hanns-Ulrich Marschall, Tharni Vasavan, Yoav Yinon, Yannick Bacq, Caroline Ovadia, Berrin Günaydin, Xiaohua Liu, Yayi Hu, Catherine Williamson, Jūratė Kondrackienė, Ayse Gul Kebapcilar, Martijn A. Oudijk, Qianwen Zhang, Kasia Maksym, Victoria Geenes, William M. Hague, Alexander Juusela, Min Ding, Levent Kebapcilar, Valeria Tripodi, Deniz Oztekin, Kajol Patel, Rocio I.R. Macias, Nicholas A. Williamson, Christian Haslinger, Monika Grymowicz, Linoy Batsry, Fergus W. Gardiner, Naciye Turk Ozterlemez, Riza Madazli, Lucy C Chappell, Peter H. Dixon, Paul T. Seed, Anna Locatelli, Kelsey Broom, Maria P.H. Koster, Laura N. Bull, Jenna Sajous, Adam Morton, Francesco Azzaroli, Katherine Kohari, Ovadia C., Sajous J., Seed P.T., Patel K., Williamson N.J., Attilakos G., Azzaroli F., Bacq Y., Batsry L., Broom K., Brun-Furrer R., Bull L., Chambers J., Cui Y., Ding M., Dixon P.H., Estiu M.C., Gardiner F.W., Geenes V., Grymowicz M., Gunaydin B., Hague W.M., Haslinger C., Hu Y., Indraccolo U., Juusela A., Kane S.C., Kebapcilar A., Kebapcilar L., Kohari K., Kondrackiene J., Koster M.P.H., Lee R.H., Liu X., Locatelli A., Macias R.I.R., Madazli R., Majewska A., Maksym K., Marathe J.A., Morton A., Oudijk M.A., Oztekin D., Peek M.J., Shennan A.H., Tribe R.M., Tripodi V., Turk Ozterlemez N., Vasavan T., Wong L.F.A., Yinon Y., Zhang Q., Zloto K., Marschall H.-U., Thornton J., Chappell L.C., Williamson C., Obstetrics and Gynaecology, ARD - Amsterdam Reproduction and Development, Ovadia, C, Sajous, J, Seed, P, Patel, K, Williamson, N, Attilakos, G, Azzaroli, F, Bacq, Y, Batsry, L, Broom, K, Brun-Furrer, R, Bull, L, Chambers, J, Cui, Y, Ding, M, Dixon, P, Estiu, M, Gardiner, F, Geenes, V, Grymowicz, M, Gunaydin, B, Hague, W, Haslinger, C, Hu, Y, Indraccolo, U, Juusela, A, Kane, S, Kebapcilar, A, Kebapcilar, L, Kohari, K, Kondrackiene, J, Koster, M, Lee, R, Liu, X, Locatelli, A, Macias, R, Madazli, R, Majewska, A, Maksym, K, Marathe, J, Morton, A, Oudijk, M, Oztekin, D, Peek, M, Shennan, A, Tribe, R, Tripodi, V, Turk Ozterlemez, N, Vasavan, T, Wong, L, Yinon, Y, Zhang, Q, Zloto, K, Marschall, H, Thornton, J, Chappell, L, Williamson, C, Obstetrics & Gynecology, and Amsterdam Reproduction & Development (AR&D)

Subjects
Cholagogues and Choleretics, medicine.medical_specialty, medicine.drug_class, Cholestasis, Intrahepatic, 03 medical and health sciences, 0302 clinical medicine, Cholestasis, Pregnancy, Internal medicine, Cholestasis of pregnancy, Humans, Medicine, Hepatology, Bile acid, business.industry, Obstetrics, Individual participant data, Gastroenterology, Obstetrics and Gynecology, General Medicine, Odds ratio, medicine.disease, Ursodeoxycholic acid, Pregnancy Complications, 030220 oncology & carcinogenesis, Meta-analysis, Female, 030211 gastroenterology & hepatology, stillbirth, Ursodeoxycholic acid, pregnancy, intrahepatic cholestasis of pregnancy, business, medicine.drug, Cohort study
Abstract

Background: Ursodeoxycholic acid is commonly used to treat intrahepatic cholestasis of pregnancy, yet its largest trial detected minimal benefit for a composite outcome (stillbirth, preterm birth, and neonatal unit admission). We aimed to examine whether ursodeoxycholic acid affects specific adverse perinatal outcomes. Methods: In this systematic review and individual participant data meta-analysis, we searched PubMed, Web of Science, Embase, MEDLINE, CINAHL, Global Health, MIDIRS, and Cochrane without language restrictions for relevant articles published between database inception, and Jan 1, 2020, using search terms referencing intrahepatic cholestasis of pregnancy, ursodeoxycholic acid, and perinatal outcomes. Eligible studies had 30 or more study participants and reported on at least one individual with intrahepatic cholestasis of pregnancy and bile acid concentrations of 40 μmol/L or more. We also included two unpublished cohort studies. Individual participant data were collected from the authors of selected studies. The primary outcome was the prevalence of stillbirth, for which we anticipated there would be insufficient data to achieve statistical power. Therefore, we included a composite of stillbirth and preterm birth as a main secondary outcome. A mixed-effects meta-analysis was done using multi-level modelling and adjusting for bile acid concentration, parity, and multifetal pregnancy. Individual participant data analyses were done for all studies and in different subgroups, which were produced by limiting analyses to randomised controlled trials only, singleton pregnancies only, or two-arm studies only. This study is registered with PROSPERO, CRD42019131495. Findings: The authors of the 85 studies fulfilling our inclusion criteria were contacted. Individual participant data from 6974 women in 34 studies were included in the meta-analysis, of whom 4726 (67·8%) took ursodeoxycholic acid. Stillbirth occurred in 35 (0·7%) of 5097 fetuses among women with intrahepatic cholestasis of pregnancy treated with ursodeoxycholic acid and in 12 (0·6%) of 2038 fetuses among women with intrahepatic cholestasis of pregnancy not treated with ursodeoxycholic acid (adjusted odds ratio [aOR] 1·04, 95% CI 0·35–3·07; p=0·95). Ursodeoxycholic acid treatment also had no effect on the prevalence of stillbirth when considering only randomised controlled trials (aOR 0·29, 95% CI 0·04–2·42; p=0·25). Ursodeoxycholic acid treatment had no effect on the prevalence of the composite outcome in all studies (aOR 1·28, 95% CI 0·86–1·91; p=0·22), but was associated with a reduced composite outcome when considering only randomised controlled trials (0·60, 0·39–0·91; p=0·016). Interpretation: Ursodeoxycholic acid treatment had no significant effect on the prevalence of stillbirth in women with intrahepatic cholestasis of pregnancy, but our analysis was probably limited by the low overall event rate. However, when considering only randomised controlled trials, ursodeoxycholic acid was associated with a reduction in stillbirth in combination with preterm birth, providing evidence for the clinical benefit of antenatal ursodeoxycholic acid treatment. Funding: Tommy's, the Wellcome Trust, ICP Support, and the National Institute for Health Research.

Published
2021

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