Ursodeoxycholic Acid in Intrahepatic Cholestasis of Pregnancy: A Systematic Review and Individual Participant Data Meta-analysis

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dc.contributor.authorOvadia, C.
dc.contributor.authorSajous, J.
dc.contributor.authorSeed, P.T.
dc.contributor.authorPatel, K.
dc.contributor.authorWilliamson, N.J.
dc.contributor.authorAttilakos, G.
dc.contributor.authorAzzaroli, F.
dc.contributor.authorBacq, Y.
dc.contributor.authorBatsry, L.
dc.contributor.authorBroom, K.
dc.contributor.authorBrun-Furrer, R.
dc.contributor.authorBull, L.
dc.contributor.authorChambers, J.
dc.contributor.authorCui, Y.
dc.contributor.authorDing, M.
dc.contributor.authorDixon, P.H.
dc.contributor.authorEstiu, M.C.
dc.contributor.authorGardiner, F.W.
dc.contributor.authorGeenes, V.
dc.contributor.authorGrymowicz, M.
dc.contributor.authoret al.
dc.date.issued2021
dc.description.abstractUrsodeoxycholic acid (UA) is a common treatment for intrahepatic cholestasis of pregnancy (ICP), and its use is supported by the Society for Maternal-Fetal Medicine. However, evidence of the benefit of UA to fetal and neonatal outcomes in this patient population is unclear. One randomized controlled trial (RCT) of 605 women with cholestasis of pregnancy demonstrated no improvement in a composite of prenatal and preterm births and admission to the neonatal unit, but it showed some improvement in the incidence of meconium-stained amniotic fluid. A Cochrane review deemed the body of evidence for UA treatment was unclear due to study limitations and design. The aim of this study is to examine the effect of UA on certain adverse prenatal outcomes. This was a systematic review and meta-analysis of individual participant data. Several medical literature databases were searched for relevant articles from their inception until January 1, 2020. Included were studies with ≥30 participants and ≥1 report of cholestasis of pregnancy and bile acid concentrations ≥40 μmol/L, plus 2 other unpublished cohort studies. Data on individual participants were collected from the authors of the studies. Outcomes included stillbirth prevalence and a composite of stillbirth and preterm birth. A total of 85 studies met the study's criteria. Individual participant data were collected on 6974 women from 34 studies, with 4726 (67.8%) women treated with UA and 2248 (32.8%) without UA treatment. Four of these studies were RCTs. Overall, the prevalence of stillbirth was 0.7% (35/5097) among women treated with UA and 0.6%(12/2038) among those without UA treatment (adjusted odds ratio [aOR], 1.04; 95% confidence interval [CI], 0.35–3.07; P = 0.95). For the composite outcome of stillbirth or preterm birth, the prevalence was 46.7% (2480/5314) and 23.2% (514/223), respectively (aOR, 1.28; 95% CI, 0.86–1.91; P = 0.22). In the RCTs alone, the prevalence of stillbirth did not differ between women treated with UA and those who were not (0.2% [1/439] vs 0.7% [3/429]; aOR, 0.29; 95% CI, 0.04–2.42; P = 0.25). In contrast, the prevalence of the composite outcome in the RCTs was 17.1% (75/439) of women treated with UA compared with 24.9% (107/429) of those who were not (aOR, 0.60; 95% CI, 0.39–0.91; P = 0.016). Overall, there was no significant effect on stillbirth prevalence in women with ICP. However, when the data were limited to RCTs, treatment with UAwas associated with a reduced composite outcome of stillbirth and preterm birth.
dc.identifier.citationObstetrical and Gynecological Survey, 2021; 76(9):521-523
dc.identifier.doi10.1097/01.ogx.0000792616.29408.2a
dc.identifier.issn0029-7828
dc.identifier.issn1533-9866
dc.identifier.orcidHague, W.M. [0000-0002-5355-2955]
dc.identifier.orcidMarathe, J.A. [0000-0002-6084-8391]
dc.identifier.urihttps://hdl.handle.net/2440/146096
dc.language.isoen
dc.publisherLippincott, Williams & Wilkins
dc.rights© 2021 Wolters Kluwer Health, Inc. All rights reserved.
dc.source.urihttps://doi.org/10.1097/01.ogx.0000792616.29408.2a
dc.subjectUrsodeoxycholic acid (UA); intrahepatic cholestasis of pregnancy (ICP); the Society for Maternal-Fetal Medicine; randomized controlled trial (RCT); women health; pregnancy
dc.titleUrsodeoxycholic Acid in Intrahepatic Cholestasis of Pregnancy: A Systematic Review and Individual Participant Data Meta-analysis
dc.typeJournal article
pubs.publication-statusPublished

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