| Title: |
Clindamycin to reduce preterm birth in a low resource setting: a randomised placebo‐controlled clinical trial |
| Authors: |
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; Derman, RJ |
| Contributors: |
Thrasher Research Fund |
| Source: |
BJOG: An International Journal of Obstetrics & Gynaecology ; volume 125, issue 12, page 1601-1609 ; ISSN 1470-0328 1471-0528 |
| Publisher Information: |
Wiley |
| Publication Year: |
2018 |
| Collection: |
Wiley Online Library (Open Access Articles via Crossref) |
| Description: |
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 |
| Document Type: |
article in journal/newspaper |
| Language: |
English |
| DOI: |
10.1111/1471-0528.15290 |
| Availability: |
https://doi.org/10.1111/1471-0528.15290; https://api.wiley.com/onlinelibrary/tdm/v1/articles/10.1111%2F1471-0528.15290; https://obgyn.onlinelibrary.wiley.com/doi/pdf/10.1111/1471-0528.15290 |
| Rights: |
http://onlinelibrary.wiley.com/termsAndConditions#vor |
| Accession Number: |
edsbas.16492CEE |
| Database: |
BASE |