Article ; Online: Oral Probiotic Supplementation in Pregnancy to Reduce Group B Streptococcus Colonisation (OPSiP trial): study protocol for a double-blind parallel group randomised placebo trial.
2024 Volume 14, Issue 2, Page(s) e076455
Abstract: Introduction: Group B streptococcus: Methods and analysis: This double-blind parallel group randomised trial aims to recruit 450 pregnant participants in Vancouver, BC, Canada and will compare GBS colonisation rates in those who have received a daily ...
Abstract | Introduction: Group B streptococcus Methods and analysis: This double-blind parallel group randomised trial aims to recruit 450 pregnant participants in Vancouver, BC, Canada and will compare GBS colonisation rates in those who have received a daily oral dose of three strains of probiotics with those who have received a placebo. The primary outcome will be GBS colonisation status, measured using a vaginal/rectal swab obtained between 35 weeks' gestation and delivery. Secondary outcomes will include maternal antibiotic exposure and urogenital infections. Analysis will be on an intention-to-treat basis. Patient or public involvement: There was no patient or public involvement in the design of the study protocol. Ethics and dissemination: This study protocol received ethics approval from the University of British Columbia's Clinical Research Ethics Board, Dublin City University and Health Canada. Findings will be presented at research rounds, conferences and in peer-reviewed publications. Trial registration number: NCT03407157. |
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MeSH term(s) | Pregnancy ; Infant, Newborn ; Female ; Humans ; Streptococcus agalactiae ; Streptococcal Infections/prevention & control ; Streptococcal Infections/drug therapy ; Canada ; Probiotics/therapeutic use ; Anti-Bacterial Agents/adverse effects ; Pregnancy Complications, Infectious/drug therapy ; Pregnancy Complications, Infectious/prevention & control ; Randomized Controlled Trials as Topic |
Chemical Substances | Anti-Bacterial Agents |
Language | English |
Publishing date | 2024-02-05 |
Publishing country | England |
Document type | Clinical Trial Protocol ; Journal Article ; Research Support, Non-U.S. Gov't |
ZDB-ID | 2599832-8 |
ISSN | 2044-6055 ; 2044-6055 |
ISSN (online) | 2044-6055 |
ISSN | 2044-6055 |
DOI | 10.1136/bmjopen-2023-076455 |
Database | MEDical Literature Analysis and Retrieval System OnLINE |
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