Objective To assess the efficacy and safety of oral sulindac in preventing the recurrence of preterm labor.
Methods This was a randomized, double-blind, placebo-controlled study of patients between 24-34 weeks' gestation with preterm labor treated with intravenous magnesium sulfate. After successful tocolysis, patients were randomized by the pharmacy to receive either oral sulindac (200 mg) or placebo (once orally every 12 hours) for 7 days.
Results Sixty-nine patients were enrolled (34 in the sulindac group, 35 controls). No significant differences were found with respect to time gained in utero (40 ± 4.4 versus 31 ± 3.4 days, P = .1), delivery at more than 35 weeks' gestation (20 versus 18, P = .70), recurrent preterm labor (11 versus 13, P = .88), birth weight (2528 ± 646 versus 2459 ± 707 g, P = .68), or time spent in the neonatal intensive care unit (4.2 ± 12.9 versus 5.7 ± 13.5 days, P = .63) for the sulindac and control groups, respectively. However, in women who failed therapy (ie, those who delivered before 37 weeks' gestation or required readmission for tocolysis), there was a significantly longer interval between the start of therapy and failure in the sulindac group (25.9 ± 3.4 days, n = 26) than in the control group (15.2 ± 2.8 days, n = 25; P < .05).
Conclusion The use of oral sulindac for 1 week after successful parenteral tocolysis failed to reduce the overall rate of preterm birth. In women who delivered prematurely or required readmission for tocolysis, oral sulindac significantly prolonged the interval from the start of therapy until delivery or readmission. Moreover, this benefit was achieved without observable adverse effects on the fetus.
Address reprint requests to: S. J. Carlan, MD, Orlando Regional Healthcare System, Department of Obstetrics and Gynecology, 105 West Miller Street, Orlando, FL 32806
© 1995 The American College of Obstetricians and Gynecologists