1. Clindamycin to reduce preterm birth in a low resource setting: a randomised placebo-controlled clinical trial.
- Author
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Bellad MB, Hoffman MK, Mallapur AA, Charantimath US, Katageri GM, Ganachari MS, Kavi A, Ramdurg UY, Bannale SG, Revankar AP, Sloan NL, Kodkany BS, Goudar SS, and Derman RJ
- Subjects
- Administration, Oral, Adolescent, Adult, Anti-Bacterial Agents administration & dosage, Clindamycin administration & dosage, Double-Blind Method, Female, Gestational Age, Humans, Incidence, India, Infant, Newborn, Maternal-Child Health Services, Medically Underserved Area, Pregnancy, Pregnancy Complications, Infectious drug therapy, Pregnancy Complications, Infectious physiopathology, Premature Birth etiology, Rural Population, Treatment Outcome, Vaginosis, Bacterial drug therapy, Vaginosis, Bacterial physiopathology, Young Adult, Anti-Bacterial Agents therapeutic use, Clindamycin therapeutic use, Premature Birth prevention & control, Prenatal Care
- Abstract
Objective: To determine whether oral clindamycin reduces the risk of preterm birth (PTB) in women with abnormal vaginal microflora as evidenced by a vaginal pH ≥5.0., Design: Randomised double-blind placebo-controlled trial., Setting: Rural southern India., Population: Pregnant women with a singleton fetus between 13
+0/7 weeks and 20+6/7 weeks., Methods: Pregnant women were recruited during prenatal visits in Karnataka, India, from October 2013 to July 2015. Women were required to have a singleton fetus between 13+0/7 weeks and 20+6/7 weeks and an elevated vaginal pH (≥5.0) by colorimetric assessment. Participants were randomised to either oral clindamycin 300 mg twice daily for 5 days or an identical-appearing placebo., Main Outcome Measures: The primary outcome was the incidence of PTB, defined as delivery before 37+0/7 weeks., Results: Of the 6476 screened women, 1727 women were randomised (block randomised in groups of six; clindamycin n = 866, placebo n = 861). The demographic, reproductive, and anthropomorphometric characteristics of the study groups were similar. Compliance was high, with over 94% of capsules being taken. The rate of PTB before 37 weeks was comparable between the two groups [clindamycin 115/826 (13.9%) versus placebo 111/806 (13.8%), between-group difference 0.2% (95% CI -3.2 to 3.5%, P = 0.93)], as was PTB at less than 34 weeks [clindamycin 40/826 (4.8%) versus placebo group 37/806 (4.6%), between-group difference 0.3% (95% CI -1.8 to 2.3%, P = 0.81)]. No differences were detected in the incidence of birthweight of<2500 g, <1500 g, miscarriage, stillbirth or neonatal death., Conclusion: In this setting, oral clindamycin did not decrease PTB among women with vaginal pH ≥5.0., Tweetable Abstract: Oral clindamycin between 13+0/7 and 20+6/7 weeks does not prevent preterm birth in women with a vaginal pH ≥5.0., (© 2018 Royal College of Obstetricians and Gynaecologists.)- Published
- 2018
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