RANDOMIZED TRIAL OF ORAL INDOMETHACIN AND TERBUTALINE SULFATE FOR THELONG-TERM SUPPRESSION OF PRETERM LABOR

OBJECTIVE: Our purpose was to determine the efficacy and safety of lon g-term oral tocolysis with indomethacin or terbutaline sulfate. STUDY DESIGN: Seventy-one patients at 26 to 32 weeks' gestation admitted for preterm labor were prospectively randomized to receive oral indometha cin or terbutaline sulfate after successful intravenous tocolysis. Pat ients were monitored weekly for cervical change, maternal side effects , amniotic fluid volume, and constriction of the fetal ductus arterios us. Patients receiving indomethacin were converted to terbutaline at 3 4 weeks or with the occurrence of fetal ductal constriction or oligohy dramnios. RESULTS: Of 71 patients randomized six were excluded after r andomization. Thirty-three patients were randomized to indomethacin an d thirty-two to terbutaline. There were no differences in the percenta ge of patients achieving 34 weeks of gestation. No differences in neon atal outcome were noted. Nine (27%) fetuses receiving indomethacin had constriction of the fetal ductus arteriosus, and 13 (38%) had oligohy dramnios. Most patients on terbutaline reported beta-mimetic side effe cts (53%), but only one required discontinuation of therapy. CONCLUSIO N: Both indomethacin and terbutaline sulfate are effective tocolytics, but major fetal side effects are common with long-term indomethacin u se.