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The efficacy of vaginal clindamycin for the treatment of abnormal genital tract flora in pregnancy.
- Source :
-
Infectious diseases in obstetrics and gynecology [Infect Dis Obstet Gynecol] 2003; Vol. 11 (4), pp. 181-9. - Publication Year :
- 2003
-
Abstract
- Objective: To assess the efficacy of 2% clindamycin vaginal cream (CVC) to treat bacterial vaginosis (BV) in pregnancy.<br />Methods: A prospective, randomized, double-blind, placebo-controlled, tricenter study. Four hundred and four women with BV on Gram stain at their first antenatal clinic visit were randomized to receive a 3-day course of 2% CVC or placebo. The outcome was assessed using an intention to treat analysis at 3 weeks and 6 weeks post-treatment according to three different diagnostic methods based on five criteria (Gram stain and all four elements of clinical composite criteria: vaginal discharge, abnormal vaginal pH, clue cells, amine odor), three criteria (vaginal pH, clue cells, amine odor) or two criteria (clue cells and amine odor) to reflect stringency of diagnosis, historical precedence and government agency recommendations respectively.<br />Results: Using five diagnostic criteria, 18% of CVC patients were cured and 70.8% either cured and/or improved compared to 1.6% and 12% of placebo patients respectively (p < 0.0001). Using three diagnostic criteria, 44.8% of CVC patients were cured and 77.3% were either cured and/or improved compared to 9.3% and 28.8% of placebo patients respectively (p < 0.000 1). Using two diagnostic criteria, 75.0% of CVC patients were cured compared to 18.0% of placebo patients (p < 0.0001 ). Recurrence rates in those CVC patients successfully treated were approximately 6% at 6 weeks post baseline and 10% at 28 to 34 weeks gestation.<br />Conclusions: A 3-day course of CVC appears to be well tolerated by the mother and statistically significantly more efficacious than placebo in the treatment of BV during the second trimester of pregnancy.
- Subjects :
- Administration, Intravaginal
Adolescent
Adult
Chi-Square Distribution
Double-Blind Method
Drug Administration Schedule
Female
Follow-Up Studies
Gram-Negative Bacteria drug effects
Gram-Positive Bacteria drug effects
Humans
Pregnancy
Pregnancy Complications, Infectious diagnosis
Pregnancy Outcome
Probability
Prospective Studies
Reference Values
Risk Assessment
Treatment Outcome
Vaginal Creams, Foams, and Jellies
Vaginal Smears
Clindamycin therapeutic use
Pregnancy Complications, Infectious drug therapy
Vaginosis, Bacterial drug therapy
Vaginosis, Bacterial microbiology
Subjects
Details
- Language :
- English
- ISSN :
- 1064-7449
- Volume :
- 11
- Issue :
- 4
- Database :
- MEDLINE
- Journal :
- Infectious diseases in obstetrics and gynecology
- Publication Type :
- Academic Journal
- Accession number :
- 15108863
- Full Text :
- https://doi.org/10.1080/10647440300025519