Pregnancy outcome in women with inflammatory bowel disease following exposure to 5-aminosalicylic acid drugs: a meta-analysis

Reprod Toxicol. 2008 Feb;25(2):271-5. doi: 10.1016/j.reprotox.2007.11.010. Epub 2007 Dec 4.


5-ASA drugs are commonly used for management of inflammatory bowel disease (IBD) during pregnancy. The safety of drug therapy for IBD during pregnancy is an important clinical concern. The present meta-analysis was performed to explore the risk of adverse pregnancy outcomes in women with IBD following exposure to 5-ASA drugs (mesalazine, sulfasalazine, balsalazide, and olsalazine). Bibliographic databases were searched upto June 2007 for studies investigating pregnancy outcomes in women with IBD following exposure to any 5-ASA drugs. The outcomes of interest were congenital abnormalities, stillbirth, spontaneous abortion, preterm delivery, and low birth weight. The odds ratios (OR) and confidence interval (CI) for the individual studies were pooled and heterogeneity analysis was performed. Seven studies with a total of 2200 pregnant women with IBD were included; 642 received 5-ASA drugs (mesalazine, sulfasalazine or olsalazine) and 1158 received no medication. The OR was found 1.16 (95% CI: 0.76-1.77, P=0.57) for congenital abnormalities, 2.38 (95% CI: 0.65-8.72, P=0.32) for stillbirth, 1.14 (95% CI: 0.65-2.01, P=0.74) for spontaneous abortion, 1.35 (95% CI: 0.85-2.13, P=0.26) for preterm delivery, and 0.93 (95% CI: 0.46-1.85, P=0.96) for low birth weight. In conclusion, this meta-analysis suggest that there is no more than an 1.16-fold increase in congenital malformations, an 2.38-fold increase in stillbirth, an 1.14-fold increase in spontaneous abortion, an 1.35-fold increase in preterm delivery, and an 0.93-fold increase in low birth weight.

Publication types

  • Meta-Analysis

MeSH terms

  • Abnormalities, Drug-Induced
  • Abortion, Spontaneous / chemically induced
  • Adult
  • Anti-Inflammatory Agents, Non-Steroidal / adverse effects*
  • Birth Weight / drug effects
  • Female
  • Fetal Death / chemically induced
  • Fetus / drug effects*
  • Humans
  • Inflammatory Bowel Diseases / drug therapy*
  • Mesalamine / adverse effects*
  • Obstetric Labor, Premature / chemically induced
  • Pregnancy
  • Pregnancy Complications / drug therapy*


  • Anti-Inflammatory Agents, Non-Steroidal
  • Mesalamine