{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,7,3]],"date-time":"2026-07-03T08:40:31Z","timestamp":1783068031087,"version":"3.54.6"},"reference-count":27,"publisher":"Wiley","issue":"12","license":[{"start":{"date-parts":[[2018,6,25]],"date-time":"2018-06-25T00:00:00Z","timestamp":1529884800000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"funder":[{"DOI":"10.13039\/100005627","name":"Thrasher Research Fund","doi-asserted-by":"publisher","award":["10326"],"award-info":[{"award-number":["10326"]}],"id":[{"id":"10.13039\/100005627","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["obgyn.onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["BJOG"],"published-print":{"date-parts":[[2018,11]]},"abstract":"<jats:sec><jats:title>Objective<\/jats:title><jats:p>To determine whether oral clindamycin reduces the risk of preterm birth (PTB) in women with abnormal vaginal microflora as evidenced by a vaginal <jats:styled-content style=\"fixed-case\">pH<\/jats:styled-content> \u22655.0.<\/jats:p><\/jats:sec><jats:sec><jats:title>Design<\/jats:title><jats:p>Randomised double\u2010blind placebo\u2010controlled trial.<\/jats:p><\/jats:sec><jats:sec><jats:title>Setting<\/jats:title><jats:p>Rural southern India.<\/jats:p><\/jats:sec><jats:sec><jats:title>Population<\/jats:title><jats:p>Pregnant women with a singleton fetus between 13<jats:sup>+0\/7<\/jats:sup> weeks and 20<jats:sup>+6\/7<\/jats:sup> weeks.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>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<jats:sup>+0\/7<\/jats:sup> weeks and 20<jats:sup>+6\/7<\/jats:sup> weeks and an elevated vaginal <jats:styled-content style=\"fixed-case\">pH<\/jats:styled-content> (\u22655.0) by colorimetric assessment. Participants were randomised to either oral clindamycin 300 mg twice daily for 5 days or an identical\u2010appearing placebo.<\/jats:p><\/jats:sec><jats:sec><jats:title>Main outcome measures<\/jats:title><jats:p>The primary outcome was the incidence of <jats:styled-content style=\"fixed-case\">PTB<\/jats:styled-content>, defined as delivery before 37<jats:sup>+0\/7<\/jats:sup> weeks.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>Of the 6476 screened women, 1727 women were randomised (block randomised in groups of six; clindamycin <jats:italic>n<\/jats:italic> = 866, placebo <jats:italic>n<\/jats:italic> = 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 <jats:styled-content style=\"fixed-case\">PTB<\/jats:styled-content> before 37 weeks was comparable between the two groups [clindamycin 115\/826 (13.9%) versus placebo 111\/806 (13.8%), between\u2010group difference 0.2% (95% <jats:styled-content style=\"fixed-case\">CI<\/jats:styled-content> \u22123.2 to 3.5%, <jats:italic>P<\/jats:italic> = 0.93)], as was <jats:styled-content style=\"fixed-case\">PTB<\/jats:styled-content> at less than 34 weeks [clindamycin 40\/826 (4.8%) versus placebo group 37\/806 (4.6%), between\u2010group difference 0.3% (95% <jats:styled-content style=\"fixed-case\">CI<\/jats:styled-content> \u22121.8 to 2.3%, <jats:italic>P<\/jats:italic> = 0.81)]. No differences were detected in the incidence of birthweight of&lt;2500 g, &lt;1500 g, miscarriage, stillbirth or neonatal death.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusion<\/jats:title><jats:p>In this setting, oral clindamycin did not decrease <jats:styled-content style=\"fixed-case\">PTB<\/jats:styled-content> among women with vaginal <jats:styled-content style=\"fixed-case\">pH<\/jats:styled-content> \u22655.0.<\/jats:p><\/jats:sec><jats:sec><jats:title>Tweetable abstract<\/jats:title><jats:p>Oral clindamycin between 13<jats:sup>+0\/7<\/jats:sup> and 20<jats:sup>+6\/7<\/jats:sup> weeks does not prevent preterm birth in women with a vaginal <jats:styled-content style=\"fixed-case\">pH<\/jats:styled-content> \u22655.0.<\/jats:p><\/jats:sec>","DOI":"10.1111\/1471-0528.15290","type":"journal-article","created":{"date-parts":[[2018,5,23]],"date-time":"2018-05-23T06:30:56Z","timestamp":1527057056000},"page":"1601-1609","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":20,"title":["Clindamycin to reduce preterm birth in a low resource setting: a randomised placebo\u2010controlled clinical trial"],"prefix":"10.1111","volume":"125","author":[{"given":"MB","family":"Bellad","sequence":"first","affiliation":[{"name":"KLE Academy of Higher Education and Research's J N Medical College Belgaum Karnataka India"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"MK","family":"Hoffman","sequence":"additional","affiliation":[{"name":"Department of Obstetrics &amp; 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