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Randomized Clinical Trial of Metronidazole Plus Erythromycin to Prevent Spontaneous Preterm Delivery in Fetal Fibronectin–Positive Women

From the Department of Obstetrics and Gynecology, Center for Research in Women’s Health, University of Alabama at Birmingham, Birmingham, Alabama; Department of Obstetrics and Gynecology, University of Tennessee, Memphis, Tennessee; The Biostatistics Center, George Washington University, Rockville, Maryland; Department of Obstetrics and Gynecology, University of Utah, Salt Lake City, Utah; Department of Obstetrics and Gynecology, Wake Forest University School of Medicine, Winston-Salem, North Carolina; The National Institute of Child Health and Human Development, Bethesda, Maryland; Department of Obstetrics and Gynecology, University of Texas Southwestern Medical Center, Dallas, Texas; Department of Obstetrics and Gynecology, Thomas Jefferson University, Philadelphia, Pennsylvania; Department of Obstetrics and Gynecology, University of Chicago, Chicago, Illinois; Department of Obstetrics and Gynecology, University of Miami, Miami, Florida; University of Pittsburgh/Magee-Women’s Hospital, Pittsburgh, Pennsylvania; Department of Obstetrics and Gynecology, Ohio State University, Columbus, Ohio; Department of Obstetrics and Gynecology, University of Texas at San Antonio, San Antonio, Texas; Department of Obstetrics and Gynecology, University of Cincinnati, Cincinnati, Ohio; and Department of Obstetrics and Gynecology, Wayne State University, Detroit, Michigan.

Address reprint requests to: William W. Andrews, PhD, MD, University of Alabama at Birmingham, Department of Obstetrics and Gynecology, 619 19th Street South—OHB 458, Birmingham, AL 35249-7333; E-mail: wandrews{at}uab.edu.

OBJECTIVE: To estimate whether antibiotic treatment of asymptomatic women with a positive cervical or vaginal fetal fibronectin test in the second trimester would reduce the risk of spontaneous preterm delivery.

METHODS: Women were screened between 21 weeks 0 days and 25 weeks 6 days of gestation with cervical or vaginal swabs for fetal fibronectin. Women with a positive test (50 ng/mL or more) were randomized to receive metronidazole (250 mg orally three times per day) and erythromycin (250 mg orally four times per day) or identical placebo pills for 10 days. The primary outcome was spontaneous delivery before 37 weeks’ gestation after preterm labor or premature membrane rupture.

RESULTS: A total of 16,317 women were screened for fetal fibronectin, and 6.6% had a positive test; 715 fetal fibronectin test–positive women consented to randomization. Outcome data were available for 703 women: 347 in the antibiotic group and 356 in the placebo group. The antibiotic and placebo groups were not significantly different for maternal age (P = .051), ethnicity (P = .849), marital status (P = .127), education (P = .244), and bacterial vaginosis (P = .236). No difference was observed in spontaneous preterm birth before 37 weeks’ (odds ratio [OR] 1.17, 95% confidence interval [CI] 0.80, 1.70), less than 35 weeks’ (OR 0.92, 95% CI 0.54, 1.56), or less than 32 weeks’ (OR 1.94, 95% CI 0.83, 4.52) gestation in antibiotic-compared with placebo-treated women. Among women with a prior spontaneous preterm delivery, the rate of repeat spontaneous preterm delivery at less than 37 weeks’ gestation was significantly higher in the active drug compared with the placebo group (46.7% versus 23.9%, P = .039).

CONCLUSION: Treatment with metronidazole plus erythromycin of asymptomatic women with a positive cervical or vaginal fetal fibronectin test in the late second trimester does not decrease the incidence of spontaneous preterm delivery.

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