Journal Article

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

Oakley, Laura L., R, Deepa, Mallinson, Poppy A. C., Birk, Nick, Babu, Giridhara R., Kinra, Sanjay, Nyirenda, Moffat

2023

Overview

Background Timely 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 design The 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 discussion Follow-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 registration ClinicalTrials.gov NCT03937050. Registered on 3 May 2019. Clinical Trials Registry India CTRI/2020/02/023605. Registered on 26 February 2020.

• Publisher: BioMed Central,BioMed Central Ltd,Springer Nature B.V,BMC
• Subject: Analysis / Behavioural intervention / Biomedicine / Blood sugar / Blood sugar monitoring / Care and treatment / Cluster randomised trial / Data collection / Diabetes in pregnancy / Diabetes therapy / Diabetes, Gestational - diagnosis / Diabetes, Gestational - therapy / Diagnosis / Educational Status / Fasting / Female / Gestational age / Gestational diabetes / Health facilities / Health planning / Health Sciences / Humans / India / Informed consent / Intervention / Maternal & child health / Medicine / Medicine & Public Health / Methods / Pregnancy / Prenatal care / Randomized Controlled Trials as Topic / Self report / Self-care, Health / Self-Management / Statistical analysis plan / Statistics for Life Sciences / Type 2 diabetes / Uganda / Update / Womens health