Category: Infectious Diseases
Poster Session II
Bacterial vaginosis (BV) and abnormal vaginal flora (AVF) are associated with preterm labor and woman's discomfort. Oral metronidazole and clindamycin are acceptable treatment during pregnancy to eradicate BV/AVF.
In the present study we aimed to compare the efficacy of each treatment to eradicate BV/AVF in women at high risk for preterm labor (e.g. previous preterm delivery, short cervix, twins or preterm contractions).
Study Design:
A multicenter randomized controlled trial was conducted. Pregnant women at high risk for preterm labor were screened for BV/AVF using the Nugent criteria in Vaginal smears. AVF and BV were defined as Nugent score 4-6 and 7-10, respectively.
Women with BV/AVF were randomly allocated to receive either oral metronidazole 500 mgX2/d or oral clindamycin 300 mgX2/d for a week as recommended by the CDC. After treatment an additional vaginal smear was taken. If BV/AVF was still present, the other treatment was given for additional week, after which eradication was assessed by a vaginal smear. The primary outcome was the rate of BV/AVF eradication after the first treatment. Adverse effect rates and delivery week were also collected.
Assuming that the rate of eradication after the first treatment was 70 versus 90%, the sample size required was 164 women (5% two-sided alpha, 90% power).
Results:
Background characteristics and study outcomes are presented in table 1 and table 2. Comparing the metronidazole and clindamycin groups, there were no differences in the rate of BV/AVF eradication [48/81 (59%) and 47/84 (56%)], total eradication rate after the second treatment [64/81 (79%) and 62/84 (74%)], and the rate of preterm delivery [29% and 25% (P=0.59)], respectively. In women who received metronidazole and clindamycin (either first or second treatment), the rate of adverse effects was 33/113 (29%) and 31/117 (26%) and, only 3% and 5% discontinued treatment due to adverse effect, respectively.
Conclusion:
In pregnant women at high risk for preterm labor, oral metronidazole and clindamycin to treat BV/AFV, had similar efficacy and adverse effects and preterm delivery rates.
Enav Yefet, MD, PhD
Department of Obstetrics and Gynecology, Baruch Padeh Medical Center Poriya
Tiberias, Israel, Israel
Sofia Soltsman, MD
Baruch Padeh Medical Center
Poriya, HaZafon, Israel
Aiman Narane, MD
Baruch Padeh Medical Center
Poriya, HaZafon, Israel
Malak Wattad, MD
Emek Medical Center
Afula, Israel, Israel
Zohar Nachum, MD
Emek Medical Center
Afula, Israel, Israel