The safety and efficacy of prolonged outpatient sulindac to prevent the recurrence of preterm labor: a prospective double-blind study

Abstract

Purpose: To assess the efficacy and safety of outpatient oral sulindac given until 34 weeks gestation to prevent the recurrence of preterm labor (PTL).Materials and Methods: Women were considered candidates for the study if they had an episode of preterm labor successfully treated with inpatient parenteral tocolysis, intact membranes, cervical dilatation <4 cm, and gestations <34 weeks. Candidates for the study were randomized by the pharmacy to receive either a "look-alike" placebo or sulindac, 100 mg po bid until 34 weeks gestation. The patient was seen for follow-up visits at 1 week and then every other week until 34 weeks. On follow-up visits hourly fetal urine production, amniotic fluid assessment, and ductal velocities were obtained.Results: Forty-four patients were randomized (21 sulindac and 23 placebo). All demographic and clinical variables were similar with the weeks at randomization 29.2 and 30.5 in the sulindac and placebo groups, respectively. Readmission for tocolysis occurred in 5 and 3 of the sulindac and placebo group patients, respectively (P = NS). Twenty and 22 of the sulindac and placebo group, respectively, delivered after 7 days. Amniotic fluid index in the sulindac group at 1 week was significantly lower than in the placebo group at 10.6 vs 13.0. All neonatal outcome variables were similar between the groups, including birth weights, Apgar, cord pH, and total NICU days.Conclusion: Sulindac until 34 weeks gestation following successful tocolysis results in no apparent prolongation of gestation.