EFFICACY AND SAFETY OF INDOMETHACIN COMPARED WITH MAGNESIUM-SULFATE IN THE MANAGEMENT OF PRETERM LABOR - A RANDOMIZED STUDY

OBJECTIVE: Our purpose was to evaluate the relative efficacy and safety of indomethacin versus magnesium sulfate in the management of preterm labor in pregnancies < 32 weeks of gestation. STUDY DESIGN: Eligible patients admitted with singleton pregnancies and idiopathic preterm labor between August 1988 and October 1989 were randomized by sealed envelopes to receive either indomethacin or intravenous magnesium sulfate. RESULTS: Of 101 eligible patients 49 were randomized to receive indomethacin. The two study groups were similar in regard to a number of entry variables, including gestational age, cervical examination, and contraction frequency. Indomethacin was as effective as magnesium sulfate in delaying delivery > 48 hours, 90% versus 85%, and together with oral terbutaline in extending the gestation, 22.9 versus 22.7 days. Tocolysis with magnesium sulfate was discontinued in eight (1 5%) patients because of maternal side effects, in contrast to none in the indomethacin group, p < 0.05. CONCLUSION: For gestations < 32 weeks indomethacin may be considered an appropriate alternative to magnesium sulfate as a first-time tocolytic agent.