OUTCOME OF THE VAGINAL INFECTIONS AND PREMATURITY STUDY - RESULTS OF A CLINICAL-TRIAL OF ERYTHROMYCIN AMONG PREGNANT-WOMEN COLONIZED WITH GROUP-B STREPTOCOCCI

被引:52
作者
KLEBANOFF, MA
REGAN, JA
RAO, AV
NUGENT, RP
BLACKWELDER, WC
ESCHENBACH, DA
PASTOREK, JG
WILLIAMS, S
GIBBS, RS
CAREY, JC
机构
[1] NIAID, BETHESDA, MD USA
[2] COLUMBIA UNIV, DEPT PEDIAT, NEW YORK, NY USA
[3] RES TRIANGLE INST, RES TRIANGLE PK, NC 27709 USA
[4] UNIV WASHINGTON, DEPT OBSTET & GYNECOL, SEATTLE, WA USA
[5] LOUISIANA STATE UNIV, DEPT OBSTET & GYNECOL, NEW ORLEANS, LA 70112 USA
[6] UNIV TEXAS, DEPT OBSTET & GYNECOL, SAN ANTONIO, TX USA
[7] UNIV OKLAHOMA, DEPT OBSTET & GYNECOL, OKLAHOMA CITY, OK 73190 USA
关键词
GROUP B STREPTOCOCCUS; STREPTOCOCCUS AGALACTIAE; LOW BIRTH WEIGHT; PRETERM BIRTH; CLINICAL TRIAL;
D O I
10.1016/0002-9378(95)90493-X
中图分类号
R71 [妇产科学];
学科分类号
100211 ;
摘要
OBJECTIVE: Our purpose was to determine whether erythromycin treatment of pregnant women colonized with group B streptococci would reduce the occurrence of low birth weight (< 2500 gm) and preterm (< 37 completed weeks) birth. STUDY DESIGN: in a double-blind clinical trial, 938 carriers of group B streptococci were randomized to receive erythromycin base (333 mg three times a day) or matching placebo beginning during the third trimester and before 30 weeks and continuing for 10 weeks or until 35 weeks 6 days of pregnancy. RESULTS: Pregnancy outcomes were available for 97% of randomized women; 14% of subjects withdrew from the trial. Birth weight < 2500 gm occurred in 8.6% of the erythromycin and 6.1% of the placebo recipients (relative risk 1.4, 0.9 to 2.2, p = 0.16). Preterm delivery occurred in 11.4% of women randomized to erythromycin and in 12.3% randomized to placebo (relative risk 0.9, 95% confidence limits 0.6 to 1.3, p = 0.65). Greater benefit of erythromycin in reducing these outcomes was not observed among women reporting the best compliance. CONCLUSIONS: In this study of pregnant women colonized with group B streptococci Treatment with erythromycin was not shown to be effective at prolonging gestation or reducing low birth weight. Greater than anticipated complicating factors, including spontaneous clearance of the organism, use of nontrial antibiotics, and density of colonization, may have resulted in population sizes too small to detect a benefit of treatment. Future studies should take these factors into account in determining sample sizes.
引用
收藏
页码:1540 / 1545
页数:6
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