Sulindac to prevent recurrent preterm labor: a randomized controlled trial.
OBJECTIVE
To assess the efficacy of oral sulindac in low doses for prolonged duration to decrease the risk of recurrent preterm labor and extend gestation.


METHODS
This was a randomized, double-blind, placebo-controlled study of patients between 24 and 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 (100 mg) or placebo orally every 12 hours until 34 weeks' gestation. A power analysis required 43 patients in each group.


RESULTS
Ninety-five patients were enrolled (46 in the sulindac group, 49 controls). No significant differences were found with respect to time gained in utero (39 +/- 25 versus 45 +/- 26 days, P = .29), delivery at more than 35 weeks' gestation (61% versus 74%, P = .29), recurrent preterm labor (20% versus 18%, P = .86), birth weight (2562 +/- 623 versus 2624 +/- 543 g, P = .62), or time spent in the neonatal intensive care unit (2.8 +/- 9.2 versus 2.4 +/- 8.6 days, P = .83) for the sulindac and control groups, respectively.


CONCLUSIONS
The use of oral sulindac until 34 weeks' gestation after successful parenteral tocolysis failed to reduce the incidence of readmission for preterm labor.
Humphrey
R G
RG
Department of Obstetrics and Gynecology, Arnold Palmer Hospital for Children and Women, Orlando, Florida, USA.
Bartfield
M C
MC
Carlan
S J
SJ
O'Brien
W F
WF
O'Leary
T D
TD
Triana
T
T
D000284:Administration, Oral; D002584:Cervix Uteri / Q000033:anatomy & histology / Q000187:drug effects; D016861:Cyclooxygenase Inhibitors / Q000627:therapeutic use*; D005260:Female; D005333:Fetus / Q000187:drug effects; D006801:Humans; D007231:Infant, Newborn; D007234:Infant, Premature; D007752:Obstetric Labor, Premature / Q000188:drug therapy / Q000517:prevention & control*; D011247:Pregnancy; D055502:Secondary Prevention; D013467:Sulindac / Q000627:therapeutic use*; D013726:Terbutaline / Q000627:therapeutic use; D015145:Tocolysis / Q000379:methods*; D015149:Tocolytic Agents / Q000627:therapeutic use; D017211:Treatment Failure
D016861:Cyclooxygenase Inhibitors; D015149:Tocolytic Agents; D013467:Sulindac; D013726:Terbutaline