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Pilot randomized trial for treatment of bacterial vaginosis using in situ forming metronidazole vaginal gel
Author(s) -
Shaaban Omar M.,
Fetih Gihan N.,
Abdellah Noura H.,
Ismail Saeyd,
Ibrahim Maggie A.,
Ibrahim Elsayed A.
Publication year - 2011
Publication title -
journal of obstetrics and gynaecology research
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.597
H-Index - 50
eISSN - 1447-0756
pISSN - 1341-8076
DOI - 10.1111/j.1447-0756.2010.01457.x
Subject(s) - bacterial vaginosis , metronidazole , medicine , cure rate , randomized controlled trial , vaginal flora , microbicide , vagina , gynecology , surgery , antibiotics , microbiology and biotechnology , immunology , human immunodeficiency virus (hiv) , biology
Aim: To compare the efficacy of a novel vaginal delivery system for metronidazole (0.8% MTZ in situ gel) versus a conventional MTZ vaginal gel product in the treatment of bacterial vaginosis (BV). Material and Methods: All consecutive patients who presented to a tertiary care hospital with symptoms suggestive of BV were approached to participate in the study. Forty‐two eligible participants were randomly assigned to either MTZ in situ gel or a conventional vaginal gel product twice daily for 5 days. All participants were re‐examined after one and 4 weeks of the beginning of treatment to ensure cure of infection and any side‐effects. Results: Demographic criteria of the participants were comparable in the two treatment groups. The cure rate after one week from the treatment was 85% in the in situ gel group and 71.4% in the conventional vaginal gel group ( P = 0.294), while after 4 weeks, the cure rate showed significant difference in the in situ gel group as compared to the conventional vaginal gel group (16/20 [80%]) and (9/19 [47.4%]), respectively ( P = 0.034). Conclusion: Pilot testing showed that in situ MTZ vaginal gel is more effective than the conventional vaginal gel for long‐term cure of BV. These findings suggest a novel and efficient long‐term treatment of BV.