Myo-inositol nutritional supplement for prevention of gestational diabetes (EMmY): a randomised, placebo-controlled, double-blind pilot trial with nested qualitative study
Doris Lanz,
Julie Dodds,
Graham Hitman,
Elena Pizzo,
Lucilla Poston,
Shakila Thangaratinam,
Chiamaka Esther Amaefule,
Zoe Drymoussi,
Francisco Jose Gonzalez Carreras,
Maria del Carmen Pardo Llorente,
Lorna Sweeney,
Amy Thomas,
James Heighway,
Jahnavi Daru,
Soha Sobhy,
Javier Zamora,
Angela Harden,
Teresa Pérez,
Asma Khalil,
Khalid Saeed Khan,
Jenny Myers,
Mohammed S B Huda
Affiliations
Doris Lanz
2 Barts Research Centre for Women`s Health, Wolfson Institute of Population Health, 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
Lucilla Poston
Department of Women and Children’s Health, Faculty of Life Sciences and Medicine, King`s College London, London, UK
Shakila Thangaratinam
2University 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
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
Lorna Sweeney
Institute for Health and Human Development, University of East London, London, UK
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
Jahnavi Daru
Institute of Population Health Sciences, Queen Mary University of London, London, UK
Soha Sobhy
4 Women’s Health Research Unit, Wolfson Institute of Population Health, Queen Mary University of London, 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
Institute for Health and Human Development, University of East London, London, UK
Teresa Pérez
Department of Statistics and Data Science, Complutense University of Madrid, Madrid, Spain
Asma Khalil
Fetal Medicine, St George`s University Hospitals NHS Foundation Trust, London, UK
Khalid Saeed Khan
Public Health, University of Granada Faculty of Medicine, Granada, Spain
Jenny Myers
Maternal and Fetal Health Research Centre, Manchester Academic Health Science Centre, The University of Manchester, Manchester, UK
Mohammed S B Huda
Department of Diabetes & Metabolism, The Royal London Hospital, London, UK
Objectives To determine the feasibility and acceptability of conducting a randomised trial on the effects of myo-inositol in preventing gestational diabetes in high-risk pregnant women.Design A multicentre, double-blind, placebo-controlled, pilot randomised trial with nested qualitative evaluation.Setting Five inner city UK National Health Service hospitalsParticipants Multiethnic pregnant women at 12+0 and 15+6 weeks’ gestation with risk factors for gestational diabetes.Interventions 2 g of myo-inositol or placebo, both included 200 µg folic acid, twice daily until delivery.Primary outcome measures Rates of recruitment, randomisation, adherence and follow-up.Secondary outcome measures Glycaemic indices (including homoeostatic model assessment-insulin resistance HOMA-IR), gestational diabetes (diagnosed using oral glucose tolerance test at 28 weeks and by delivery), maternal, perinatal outcomes, acceptability of intervention and costs.Results Of the 1326 women screened, 58% (773/1326) were potentially eligible, and 27% (205/773) were recruited. We randomised 97% (198/205) of all recruited women (99 each in intervention and placebo arms) and ascertained outcomes in 90% of women (178/198) by delivery. The mean adherence was 52% (SD 44) at 28 weeks’ and 34% (SD 41) at 36 weeks’ gestation. HOMA-IR and serum insulin levels were lower in the myo-inositol vs placebo arm (mean difference −0.6, 95% CI −1.2 to 0.0 and −2.69, 95% CI −5.26 to −0.18, respectively). The study procedures were acceptable to women and healthcare professionals. Women who perceived themselves at high risk of gestational diabetes were more likely to participate and adhere to the intervention. The powder form of myo-inositol and placebo, along with nausea in pregnancy were key barriers to adherence.Conclusions A future trial on myo-inositol versus placebo to prevent gestational diabetes is feasible. The intervention will need to be delivered in a non-powder form to improve adherence. There is a signal for efficacy in reducing insulin resistance in pregnancy with myo-inositol.Trial registration number ISRCTN48872100.
