Indomethacin is a prostaglandin synthetase inhibitor sometimes used for toc
olysis. Several placebo-controlled trials and trials comparing indomethacin
to other potential first-line tocolytic agents support its efficacy for de
laying delivery for >48 hours. Recent observational studies, however, have
raised concerns about the safety of indomethacin, implicating it with incre
ased rates of intraventricular hemorrhage and necrotizing enterocolitis. Ca
reful analysis of these observational studies suggests that these results s
hould be viewed with caution, because of uncontrolled confounding by indica
tion. A recent decision analysis supports the risk/benefit analysis of indo
methacin in this setting. Still, the future of indomethacin in preterm labo
r should be guided by well-designed prospective clinical trials. Such studi
es are underway.