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Exposure to corticosteroids in pregnancy is associated with adverse perinatal outcomes among infants of mothers with inflammatory bowel disease: results from the PIANO registry
  1. Florence-Damilola Odufalu1,
  2. Millie Long2,
  3. Kirk Lin3,
  4. Uma Mahadevan1
  5. PIANO Investigators from the Crohn’s and Colitis Foundation (CCF) Clinical Research Alliance recruited patients for their respective centers for participant enrollment
    1. 1Division of Gastroenterology and Hepatology, Department of Medicine, University of California San Francisco, San Francisco, California, USA
    2. 2Division of Gastroenterology and Hepatology, Department of Medicine, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, USA
    3. 3Department of Gastroenterology, Palo Alto Medical Foundation, Fremont, California, USA
    1. Correspondence to Dr Uma Mahadevan, Department of Medicine, University of California San Francisco, San Francisco, USA; uma.mahadevan{at}ucsf.edu

    Abstract

    Objective Active inflammatory bowel disease (IBD) during pregnancy may require the use of corticosteroids. The aim of this study was to investigate the impact of in utero corticosteroid exposure on adverse pregnancy outcomes, congenital malformations, infections and neurocognitive development among offspring of mothers with IBD.

    Design Using the prospective Pregnancy in Inflammatory Bowel Disease and Neonatal Outcomes registry, data were collected at each trimester, delivery; and in the 12 months post partum. Bivariate statistics and multivariate logistic regression models compared pregnancy outcomes by corticosteroid exposure.

    Results A total of 1490 mothers with IBD were enrolled, with 1431 live births recorded. Corticosteroid use was associated with increased risk of preterm birth, small for gestational age, low birth weight (LBW), intrauterine growth restriction and neonatal intensive care unit (NICU) admission. On adjusted multivariate models, corticosteroid use was associated with preterm birth (OR 1.79, 95% CI 1.18 to 2.73), LBW (OR 1.76, 95% CI 1.07 to 2.88) and NICU admission (OR 1.54, 95% CI 1.03 to 2.30). Late corticosteroid use (second and/or third trimester) was associated with serious infections at 9 and 12 months (4% vs 2% and 5% vs 2%, respectively, p=0.03 and p=0.001). There were five newborns with in utero corticosteroid exposure born with orofacial clefts versus one without corticosteroid exposure. Developmental milestones were similar across corticosteroid exposure groups.

    Conclusion In this prospective pregnancy registry, offspring of women exposed to corticosteroids during pregnancy were more likely to have adverse pregnancy outcomes. This emphasises the importance of controlling disease activity before and during pregnancy with steroid-sparing therapy.

    • IBD
    • inflammatory bowel disease
    • paediatric gastroenterology
    • ulcerative colitis
    • Crohn's disease

    Data availability statement

    All data relevant to the study are included in the article or uploaded as supplementary information.

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    Data availability statement

    All data relevant to the study are included in the article or uploaded as supplementary information.

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    Footnotes

    • Collaborators PIANO Investigators from the Crohn’s and Colitis Foundation (CCF) Clinical Research Alliance recruited patients for their respective centers for participant enrollment: Doug Wolf, Francis Farraye, Sonia Friedman, Silvia Degli-Esposti, Eugene Greenberg, Christina Ha, Arun Swaminath, Corey Siegel, Robert Erickson, Samir Shah, Bincy Abraham, Ashwin, Ananthakrishnan, Sunanda Kane, Daniel Stein, Lilani Perera, Robert McCabe, Marla Dubinsky, Steven Hanauer, Jeffry Katz, Russell Cohen, Sarah Glover, David Elliott, Lisbeth Selby, Kim Isaacs, James Lewis, Joseph Sellin, Eric Ganguly, Sumona Saha, Dawn Beaulieu, Richard Bloomfeld, Themistocles, Dassopoulous, Ellen Scherl, Vinita Jacob.

    • Contributors FDO: study concept; acquisition of data; analysis and interpretation of data; drafting of the manuscript; critical revision of the manuscript. MDL: acquisition of data; analysis and interpretation of data; drafting of the manuscript; critical revision of the manuscript for important intellectual content; statistical analysis. KL: study concept; drafting of the manuscript. UM: author guarantor; study concept and design; acquisition of data; analysis and interpretation of data; drafting of the manuscript; critical revision of the manuscript for important intellectual content; obtained funding; study supervision. This work was supported by the Crohn’s and Colitis Foundation (CCF) Senior Research Award and the Barry and Marie Lipman Family Fund. Study sponsors did not contribute to the study design, collection, analysis and interpretations of data; writing or decision to submit the paper for publication.

    • Funding This study was supported by the Crohn’s and Colitis Foundation (CCF) Senior Research Award and the Barry and Marie Lipman Family Fund. Study sponsors did not contribute to the study design, collection, analysis and interpretations of data; writing or decision to submit the paper for publication.

    • Competing interests ML: Consultant - Janssen, AbbVie, Takeda, Pfizer, Target Pharmasolutions, Lilly, BMS, Genentech, Roche, Calibr, Salix, Valeant, Theravance, and Research support Pfizer, and Takeda. UM: Consultant - Janssen, AbbVie, Takeda and Pfizer. The remaining authors declare no conflicts of interest.

    • Patient and public involvement Patients and/or the public were not involved in the design, or conduct, or reporting, or dissemination plans of this research.

    • Provenance and peer review Not commissioned; externally peer reviewed.

    • Author note Doug Wolf: Atlanta Gastroenterology Associates. Francis Farraye: Boston Medical Center Section of Gastroenterology. Sonia Friedman: Brigham and Women's Hospital. Silvia Degli-Esposti: Brown University Women and Infants Hospital. Eugene Greenberg: Carle Foundation Hospital. Christina Ha: Cedars Sinai Medical Center. Arun Swaminath: Columbia University Medical Center/New York Presbyterian Hospital. Corey Siegel: Dartmouth Hitchcock Medical Center. Robert Erickson: Duluth Clinic Health System. Samir Shah: Gastroenterology Associates Inc. Bincy Abraham: Houston Methodist Research Institute + Baylor College of Medicine. Ashwin: Massachusetts General Hospital. Ananthakrishnan, Sunanda Kane: Mayo Clinic Rochester Minnesota. Daniel Stein and Lilani Perera: Medical College of Wisconsin. Robert McCabe: Minnesota Gastroenterology. Marla Dubinsky: Mount Sinai Medical Center, NY. Steven Hanauer: Northwestern. Jeffry Katz: University Hospitals Case Medical Center. Russell Cohen: University of Chicago. Sarah Glover: University of Florida. David Elliott: University of Iowa. Lisbeth Selby: University of Kentucky. Kim Isaacs: University of North Carolina. James Lewis: University of Pennsylvania Health System. Joseph Sellin: University of Texas Medical Branch. Eric Ganguly: University of Vermont College of Medicine. Sumona Saha: University of Wisconsin-Madison. Dawn Beaulieu: Vanderbilt University Medical Center. Richard Bloomfeld: Wake Forest University School of Medicine. Themistocles: Washington University in St. Louis. Dassopoulous Ellen Scherl and Vinita Jacob: Weill Cornell Medical College.

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