INFLAMMATION AND INFLAMMATORY BOWEL DISEASE

Birth outcome in women exposed to 5-aminosalicylic acid during pregnancy: a Danish cohort study

B Nørgård¹, K Fonager², L Pedersen¹, B A Jacobsen³, H T Sørensen⁴

¹ Department of Clinical Epidemiology, Aarhus University Hospital, DK-8000 Aarhus C, Denmark
² Department of Epidemiology and Social Medicine, University of Aarhus, DK-8000 Aarhus C, Denmark
³ Department of Medicine M, Aalborg Hospital, DK-9000 Aalborg, Denmark
⁴ Department of Clinical Epidemiology, and Department of Medicine V, Aarhus University Hospital, DK-8000 Aarhus C, Denmark.

Correspondence to:
Correspondence to:
Dr B Nørgård, Department of Clinical Epidemiology, Aarhus University Hospital, Building 260, DK-8000 Aarhus C, Denmark;
bn{at}soci.au.dk

Background: 5-Aminosalicylic acid (5-ASA) preparations are the firstline drugs in the treatment of inflammatory bowel disease. Data on the safety of these drugs in pregnancy are sparse.

Aims: To examine the risk of adverse birth outcome in women who were prescribed 5-ASA drugs during pregnancy.

Patients: Women were included in the study if they were prescribed 5-ASA drugs immediately before or during pregnancy. To examine the risk of malformations, we included 60 pregnancies exposed to 5-ASA drugs 30 days before pregnancy or in the first trimester. To examine stillbirths, preterm births, and low birth weight, we included 88 pregnancies exposed during the entire pregnancy. Outcomes were compared with those of 19 418 pregnancies in which no drugs were prescribed for mothers during the study period.

Methods: We conducted a Danish cohort study based on data from a population based prescription registry, the Danish Birth Registry, and the Hospital Discharge Registry in North Jutland County.

Results: Odds ratios for malformations, stillbirth, preterm birth, and low birth weight in women who received prescriptions for 5-ASA drugs were 1.9 (95% confidence interval 0.7–5.4), 6.4 (1.7–24.9), 1.9 (0.9–3.9), and 1.2 (0.4–3.3), respectively. The increased risk of stillbirth and preterm birth were found only in patients with ulcerative colitis.

Conclusions: We found an increased risk of stillbirth and preterm birth in women who had been prescribed 5-ASA drugs during pregnancy but no substantial increased risk of malformations. It was difficult to distinguish the specific effects of disease activity and 5-ASA drugs.

Keywords: 5-aminosalicylic acid; inflammatory bowel disease; pregnancy outcome; preterm birth; stillbirth

Abbreviations: 5-ASA, 5-aminosalicylic acid; ATC, anatomical therapeutic chemical; CD, Crohn's disease; IBD, inflammatory bowel diseases; OR, odds ratio; UC, ulcerative colitis

CiteULike    Complore    Connotea    Del.icio.us    Digg    Reddit    Technorati    What's this?

Relevant Articles

Inflammatory bowel disease in pregnancy

E M Alstead and C Nelson-Piercy
Gut 2003 52: 159-161. [Abstract] [Full Text] [PDF]

Digest

Ian Forgacs
Gut 2003 52: 159. [Extract] [Full Text] [PDF]

This article has been cited by other articles:

• Cornish, J, Tan, E, Teare, J, Teoh, T G, Rai, R, Clark, S K, Tekkis, P P (2007). A meta-analysis on the influence of inflammatory bowel disease on pregnancy. Gut 56: 830-837 [Abstract] [Full Text]  
• Mahadevan, U (2006). Fertility and pregnancy in the patient with inflammatory bowel disease.. Gut 55: 1198-1206 [Full Text]  
• Caprilli, R, Gassull, M A, Escher, J C, Moser, G, Munkholm, P, Forbes, A, Hommes, D W, Lochs, H, Angelucci, E, Cocco, A, Vucelic, B, Hildebrand, H, Kolacek, S, Riis, L, Lukas, M, de Franchis, R, Hamilton, M, Jantschek, G, Michetti, P, O'Morain, C, Anwar, M M, Freitas, J L, Mouzas, I A, Baert, F, Mitchell, R, Hawkey, C J, for the European Crohn's and Colitis Organisation, (2006). European evidence based consensus on the diagnosis and management of Crohn's disease: special situations. Gut 55: i36-i58 [Abstract] [Full Text]  
• Carter, M J, Lobo, A J, Travis, S P L (2004). Guidelines for the management of inflammatory bowel disease in adults. Gut 53: v1-v16 [Full Text]  
• (2003). Lucina. Arch. Dis. Child. 88: 462-462 [Full Text]  
• Alstead, E M, Nelson-Piercy, C (2003). Inflammatory bowel disease in pregnancy. Gut 52: 159-161 [Abstract] [Full Text]