Statistical analysis plan and protocol updates for Gestational diabetes in Uganda and India: Design and Evaluation of Educational Films for Improving Screening and Self-management (GUIDES) trial

Trials

Update

Nick Birk¹  Sanjay Kinra¹  Poppy A. C. Mallinson¹  Laura L. Oakley²  Moffat Nyirenda³  Giridhara R. Babu⁴  Deepa R⁴ 

[1] Department of Non-Communicable Disease Epidemiology, London School of Hygiene and Tropical Medicine, Keppel Street, WC1E 7HT, London, UK;Department of Non-Communicable Disease Epidemiology, London School of Hygiene and Tropical Medicine, Keppel Street, WC1E 7HT, London, UK;Centre for Fertility and Health, Norwegian Institute of Public Health, P.O. box 222, Skøyen, N-0213, Oslo, Norway;Department of Non-Communicable Disease Epidemiology, London School of Hygiene and Tropical Medicine, Keppel Street, WC1E 7HT, London, UK;MRC/UVRI and LSHTM Uganda Research Unit, Entebbe, Uganda;Indian Institute of Public Health-Bengaluru, Public Health Foundation of India (PHFI), Bengaluru, India;

关键词: Statistical analysis plan;    Gestational diabetes;    Behavioural intervention;    Cluster randomised trial;   

DOI  :  10.1186/s13063-023-07508-5

 received in 2023-03-13, accepted in 2023-07-10,  发布年份 2023

来源: Springer

【 摘 要 】

BackgroundTimely detection and management of gestational diabetes mellitus (GDM) have been identified as a high priority for policymakers in low- and middle-income countries (LMICs). The GUIDES trial will evaluate a package of three interconnected film-based interventions aimed at improving the timely detection and management of GDM. The protocol for this trial has previously been published; this publication outlines the statistical analysis plan for the trial.Methods and designThe GUIDES study is a multi-country cluster-randomised controlled trial consisting of one trial conducted in Uganda and one in India (30 clusters in each country). Mixed effects models will be used to compare the primary study outcomes of the proportion of women who are tested for GDM between 24 and 32 weeks of pregnancy and the mean fasting blood sugar of women with GDM at 34-week follow-up while accounting for clustering. Secondary analyses will compare the proportion of women with self-reported GDM diagnosis at 32 weeks of pregnancy and the proportion of women with adverse perinatal outcomes related to GDM up to 4 weeks after birth in each trial arm.Trial status and discussionFollow-up is expected to end in March 2023 in Uganda and in May 2023 in India. Analyses will be carried out following this statistical analysis plan in the month following trial completion.Trial registrationClinicalTrials.gov NCT03937050. Registered on 3 May 2019. Clinical Trials Registry India CTRI/2020/02/023605. Registered on 26 February 2020.

【 授权许可】

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© BioMed Central Ltd., part of Springer Nature 2023