Randomized investigation of antimicrobials for the prevention of preterm birth.
OBJECTIVE
Occult amniotic fluid infection has emerged as a possible cause of many heretofore unexplained preterm births. We sought to determine whether antimicrobial therapy is effective in preventing preterm delivery.


METHODS
A double-blind, placebo-controlled, randomized trial was conducted to study the efficacy of ampicillin-sulbactam and amoxicillin-clavulanic acid in women hospitalized for preterm labor between 24 and 34 weeks' gestation. During this investigation no tocolytics or steroids were used.


RESULTS
Thirty-nine women with preterm labor received antimicrobial therapy and 39 received placebos. The mean gestational ages at study entry were 29.8 +/- 0.4 weeks (SEM) and 30.6 +/- 0.3 weeks in the antimicrobial and placebo groups, respectively (not significant). Similarly, the mean gestational ages at delivery were 34.2 +/- 0.7 and 34.1 +/- 0.6 weeks, respectively (not significant). Other index values of pregnancy outcome, for example, birth weight, neonatal morbidity, and prenatal death, were not significantly improved by antimicrobial therapy given to the mother in preterm labor.


CONCLUSIONS
We find that antimicrobial therapy given to women in preterm labor is ineffective in the prevention of preterm birth.
Cox
S M
SM
Department of Obstetrics and Gynecology, University of Texas Southwestern Medical School, Dallas 75235-9032, USA.
Bohman
V R
VR
Sherman
M L
ML
Leveno
K J
KJ
D000658:Amoxicillin / Q000627:therapeutic use; D000667:Ampicillin / Q000627:therapeutic use; D000900:Anti-Bacterial Agents / Q000627:therapeutic use*; D019818:Clavulanic Acid; D002969:Clavulanic Acids / Q000627:therapeutic use; D004311:Double-Blind Method; D005260:Female; D005865:Gestational Age; D006801:Humans; D007752:Obstetric Labor, Premature / Q000188:drug therapy*; D010406:Penicillins / Q000627:therapeutic use; D010919:Placebos; D011247:Pregnancy; D011256:Pregnancy Outcome; D013407:Sulbactam / Q000627:therapeutic use
D000900:Anti-Bacterial Agents; D002969:Clavulanic Acids; D010406:Penicillins; D010919:Placebos; D019818:Clavulanic Acid; D000667:Ampicillin; D000658:Amoxicillin; D013407:Sulbactam