Combination antibiotics and indomethacin in idiopathic preterm labor: a randomized double-blind clinical trial.
Subclinical infection may play a role in the failure of magnesium sulfate tocolysis. Using a double-blind randomized study design, we administered a combination of ampicillin-sulbactam and indomethacin or corresponding placebos to patients in preterm labor who were receiving intravenous magnesium sulfate tocolysis. The mean gestational age at enrollment was 30.1 weeks, and mean cervical dilatation was 2.15 cm. No differences were noted between placebo (n = 43) and study patients (n = 43) in gestational age at delivery, term deliveries, days gained, or neonatal outcome. Preterm delivery (less than 36 weeks) occurred in 61% of the total population. The likelihood of a beta error was 0.07 to 0.23 on the basis of outcome analysis. In our population adjunctive ampicillin-sulbactam with indomethacin did not improve the success of magnesium sulfate tocolysis.
Newton
E R
ER
Department of Obstetrics and Gynecology, University of Texas Health Science Center, San Antonio 78284-7836.
Shields
L
L
Ridgway
L E
LE
Berkus
M D
MD
Elliott
B D
BD
D000667:Ampicillin / Q000627:therapeutic use*; D001424:Bacterial Infections / Q000188:drug therapy*; D004311:Double-Blind Method; D004359:Drug Therapy, Combination / Q000627:therapeutic use; D005260:Female; D006801:Humans; D007213:Indomethacin / Q000627:therapeutic use*; D008278:Magnesium Sulfate / Q000627:therapeutic use; D007752:Obstetric Labor, Premature / Q000188:drug therapy*; D011247:Pregnancy; D011256:Pregnancy Outcome; D013407:Sulbactam / Q000627:therapeutic use*
C035444:sultamicillin; D008278:Magnesium Sulfate; D000667:Ampicillin; D013407:Sulbactam; D007213:Indomethacin