Effectiveness and acceptability of myoinositol nutritional supplement in the prevention of gestational diabetes (EMmY): A protocol for a randomised, placebo-controlled, double-blind pilot trial

Chiamaka Esther Amaefule*, Zoe Drymoussi, Julie Dodds, Lorna Sweeney, Elena Pizzo, Jahnavi Daru, John Robson, Lucilla Poston, Asma Khalil, Jenny Myers, Angela Harden, Graham A. Hitman, Khalid Khan, Javier Zamora, Mohammed S.B. Huda, Shakila Thangaratinam

*Corresponding author for this work

Research output: Contribution to journalArticlepeer-review

9 Citations (Scopus)


Introduction Gestational diabetes increases maternal and offspring complications in pregnancy and cardiovascular complications in the long term. The nutritional supplement myo-inositol may prevent gestational diabetes; however, further evaluation is required, especially in multiethnic high-risk mothers. Our pilot trial on myo-inositol to prevent gestational diabetes will evaluate trial processes, assess acceptability to mothers and obtain preliminary estimates of effect and cost data prior to a large full-scale trial. Methods and analysis EMmY is a multicentre, placebocontrolled, double-blind, pilot, randomised trial, with qualitative evaluation. We will recruit pregnant women at 12-15+6 weeks' gestation, with gestational diabetes risk factors, from five maternity units in England between 2018 and 2019. We will randomise 200 women to take either 2 g of myo-inositol powder (intervention) or placebo, twice daily until delivery. We will assess rates of recruitment, randomisation, adherence to intervention and follow-up. Gestational diabetes will be diagnosed at 24-28 weeks as per the National Institute for Health and Care Excellence (NICE) criteria (fasting plasma glucose: ≥5.6 mmol/L and 2-hour plasma glucose: ≥7.8 mmol/L). We will assess the effects of myo-inositol on glycaemic indices at 28 weeks and on other maternal, fetal and neonatal outcomes at postnatal discharge. Qualitative evaluation will explore the acceptability of the trial and the intervention among women and healthcare professionals. Cost data and health-related quality of life measures will be captured. We will summarise feasibility outcomes using standard methods for proportions and other descriptive statistics, and where appropriate, report point estimates of effect sizes (eg, mean differences and relative risks) and associated 95% CIs. Ethics and dissemination Ethical approval was obtained through the London Queen Square Research Ethics Committee (17/LO/1741). Study findings will be submitted for publication in peer-reviewed journals. Newsletters will be made available to participants, healthcare professionals and members of Katie's Team (a patient and public advisory group) to disseminate.

Original languageEnglish
Article numbere022831
JournalBMJ open
Issue number9
Publication statusPublished - 24 Sept 2018

Bibliographical note

Funding Information:
Funding This work was supported by Barts Charity, grant number MGU0373. The trial sponsor is Queen Mary University of London (sponsorsrep@bartshealth.nhs.uk). This research was supported by the National Institute for Health Research (NIHR) Collaboration for Leadership in Applied Health Research and Care North Thames at Barts Health NHS Trust (NIHR CLAHRC North Thames).

Publisher Copyright:
© Author(s) (or their employer(s)) 2018.

ASJC Scopus subject areas

  • General Medicine


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