Metformin in the prevention of type 2 diabetes after gestational diabetes in postnatal women (OMAhA): a UK multicentre randomised, placebo-controlled, double-blind feasibility trial with nested qualitative study
Doris Lanz,
Julie Dodds,
Graham Hitman,
Elena Pizzo,
Shakila Thangaratinam,
Chiamaka Esther Amaefule,
Angeliki Bolou,
Zoe Drymoussi,
Francisco Jose Gonzalez Carreras,
Maria del Carmen Pardo Llorente,
Amy Thomas,
James Heighway,
Anita Sanghi,
Javier Zamora,
Angela Harden,
Teresa Pérez,
Mohammed S B Huda
Affiliations
Doris Lanz
BARC (Barts Research Centre for Women’s Health), Wolfson Institute of Population Health, Barts and the London School of Medicine and Dentistry, Queen Mary University of London, London, UK
Julie Dodds
BARC (Barts Research Centre for Women’s Health), Wolfson Institute of Population Health, Barts and the London School of Medicine and Dentistry, Queen Mary University of London, London, UK
Graham Hitman
Queen Mary University of London, London, UK
Elena Pizzo
University College London, London, UK
Shakila Thangaratinam
WHO Collaborating Centre for Global Women’s Health, Institute of Metabolism and Systems Research, University of Birmingham, Birmingham, UK
Chiamaka Esther Amaefule
BARC (Barts Research Centre for Women’s Health), Wolfson Institute of Population Health, Barts and the London School of Medicine and Dentistry, Queen Mary University of London, London, UK
Angeliki Bolou
Institute of Lifecourse Development: Centre of Chronic Illness and Aging, Faculty of Education, Health & Human Sciences, University of Greenwich, London, UK
Zoe Drymoussi
BARC (Barts Research Centre for Women’s Health), Wolfson Institute of Population Health, Barts and the London School of Medicine and Dentistry, Queen Mary University of London, London, UK
Francisco Jose Gonzalez Carreras
BARC (Barts Research Centre for Women’s Health), Wolfson Institute of Population Health, Barts and the London School of Medicine and Dentistry, Queen Mary University of London, London, UK
Maria del Carmen Pardo Llorente
Department of Statistics and Operational Research, Complutense University of Madrid, Madrid, Spain
Amy Thomas
Women’s Health Research Unit, Barts Health NHS Trust, London, UK
James Heighway
BARC (Barts Research Centre for Women’s Health), Blizard Institute, Barts and the London School of Medicine and Dentistry, Queen Mary University of London, London, UK
Anita Sanghi
Obstetrics & Gynaecology, The Royal London Hospital, London, UK
Javier Zamora
WHO Collaborating Centre for Global Women’s Health, Institute of Metabolism and Systems Research, University of Birmingham, Birmingham, UK
Angela Harden
City University of London, London, UK
Teresa Pérez
Department of Statistics and Data Science, Complutense University of Madrid, Madrid, Spain
Mohammed S B Huda
Department of Diabetes & Metabolism, The Royal London Hospital, London, UK
Objective To determine the feasibility of a definitive trial of metformin to prevent type 2 diabetes in the postnatal period in women with gestational diabetes.Design A multicentre, placebo-controlled, double-blind randomised feasibility trial with qualitative evaluation.Setting Three inner-city UK National Health Service hospitals in London.Participants Pregnant women with gestational diabetes treated with medication.Interventions 2 g of metformin (intervention) or placebo (control) from delivery until 1 year postnatally.Primary outcome measures Rates of recruitment, randomisation, follow-up, attrition and adherence to the intervention.Secondary outcome measures Preliminary estimates of glycaemic effects, qualitative exploration, acceptability of the intervention and costs.Results Out of 302 eligible women, 57.9% (175/302) were recruited. We randomised 82.3% (144/175) of those recruited, with 71 women in the metformin group and 73 women in the placebo group. Of the participants remaining in the study and providing any adherence information, 54.1% (59/109) took at least 75% of the target intervention dose; the overall mean adherence was 64% (SD 33.6). Study procedures were found to be acceptable to women and healthcare professionals. An increased perceived risk of developing type 2 diabetes, or a positive experience of taking metformin during pregnancy, encouraged participation and adherence to the intervention. Barriers to adherence included disruption to the medication schedule caused by the washout periods ahead of each study visit or having insufficient daily reminders.Conclusions It is feasible to run a full-scale definitive trial on the effectiveness of metformin to prevent type 2 diabetes in women with gestational diabetes, during the early postnatal period. Adherence and engagement with the study could be improved with more regular reminders and potentially the addition of ongoing educational or peer support to reinforce messages around type 2 diabetes prevention.Trial registration number ISRCTN20930880.
