Abstract
BackgroundThe prevalence of gestational diabetes mellitus (GDM) is rising rapidly in many low- and middle-income countries (LMICs). Most women with GDM in LMICs are undiagnosed and/or inadequately managed due to a lack of knowledge and skills about GDM on the part of both providers and patients. Following contextual analysis, we developed an educational/behavioural intervention for GDM delivered through a package of culturally tailored films. This trial aims to evaluate whether the intervention can improve the timely detection and management of GDM in two LMIC settings.MethodsTwo independent cluster randomised controlled trials, one each to be conducted in Uganda and India. Thirty maternity facilities in each country have been recruited to the study and randomised in a 1:1 ratio to the intervention and control arms. The intervention comprises of three interconnected sets of films with the following aims: to improve knowledge of GDM guidelines and skills of health providers, to raise awareness of GDM screening among pregnant women and their families, and to improve confidence and skills in self-management among those diagnosed with GDM. In facilities randomised to the intervention arm, a GDM awareness-raising film will be shown in antenatal care waiting rooms, and four films for pregnant women with GDM will be shown in group settings and made available for viewing on mobile devices. Short films for doctors and nurses will be presented at professional development meetings. Data will be collected on approximately 10,000 pregnant women receiving care at participating facilities, with follow-up at 32 weeks gestational age and 6 weeks postnatally. Women who self-report a GDM diagnosis will be invited for a clinic visit at 34 weeks. Primary outcomes are (a) the proportion of women who report a GDM diagnosis by 32 weeks of pregnancy and (b) glycaemic control (fasting glucose and HbA1C) in women with GDM at ~34 weeks of pregnancy. The secondary outcome is a composite measure of GDM-related adverse perinatal-neonatal outcome.DiscussionScreening and management of GDM are suboptimal in most LMICs. We hypothesise that a scalable film-based intervention has the potential to improve the timely detection and management of GDM in varied LMIC settings.Trial registrationClinicalTrials.gov NCT03937050, registered on 3 May 2019. Clinical Trials Registry India CTRI/2020/02/023605, registered on 26 February 2020.
Highlights
The prevalence of gestational diabetes mellitus (GDM) is rising rapidly in many low- and middle-income countries (LMICs)
A survey of key informants from 40 LMICs identified the unavailability of relevant guidelines and lack of knowledge about GDM on the part of both providers and patients as a significant barrier to detection and management of GDM [15, 16]
Aim The primary aim of the two trials is to determine whether an educational/behavioural intervention delivered through a package of culturally tailored films for pregnant women, their family members and health providers can improve timely detection, glycaemic control and clinical outcomes of women with GDM
Summary
Aim The primary aim of the two trials is to determine whether an educational/behavioural intervention delivered through a package of culturally tailored films for pregnant women, their family members and health providers can improve timely detection, glycaemic control and clinical outcomes of women with GDM. Power and sample size Our pilot data suggests that we will be able to recruit ~10,000 pregnant women in each country during the 1year recruitment period (~1 delivery/day/unit), of which ~10% (n=500) in intervention arm and ~5% (n=250) in the control arm are expected to be diagnosed with GDM (these figures may be lower in Uganda where screening prevalence is thought to be lower). Our estimated sample size requirements, based on preliminary data from Bengaluru and supplemented from literature, for 80% power at 5% significance level, and accounting for an indicative clustering of 0.01 for all outcomes, are 1218 pregnant women for GDM detection (5% vs 10%), 180 women with GDM for glycaemic control (fasting glucose difference of 0.3 mmol/L, for an SD of 0.9 mmol/L) [30] and 5935 women for our composite measure of adverse perinatal and neonatal outcome (30% vs 35%) [27] These figures are considerably lower than our planned sample size. A lay summary of our research will be disseminated to stakeholders via social media, local networks and participating health facilities
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