Myo-inositol nutritional supplement for prevention of gestational diabetes (EMmY): a randomised, placebo-controlled, double-blind pilot trial with nested qualitative study

• Published in: BMJ open Vol. 12; no. 3; p. e050110
• Main Authors: Amaefule, Chiamaka Esther, Drymoussi, Zoe, Gonzalez Carreras, Francisco Jose, Pardo Llorente, Maria del Carmen, Lanz, Doris, Dodds, Julie, Sweeney, Lorna, Pizzo, Elena, Thomas, Amy, Heighway, James, Daru, Jahnavi, Sobhy, Soha, Poston, Lucilla, Khalil, Asma, Myers, Jenny, Harden, Angela, Hitman, Graham, Khan, Khalid Saeed, Zamora, Javier, Pérez, Teresa, Huda, Mohammed S B, Thangaratinam, Shakila
• Format: Journal Article
• Language: English
• Published: England British Medical Journal Publishing Group 11-03-2022; BMJ Publishing Group LTD; BMJ Publishing Group
• Series: Original research
• Subjects: Clinical outcomes; Consent; Costs; diabetes in pregnancy; Diabetes, Gestational - diagnosis; Dietary supplements; Double-Blind Method; Double-blind studies; Female; Gestational diabetes; Glucose; health economics; Health services; Humans; Inner city; Inositol; Insulin; Insulin Resistance; Intervention; Interviews; Laboratories; Male; maternal medicine; Medical personnel; Obstetrics and Gynaecology; Participation; Pilot Projects; Pregnancy; Prevention; Public health; Qualitative research; Quality of life; Questionnaires; State Medicine; Womens health; maternal medicine; qualitative research; diabetes in pregnancy; public health; health economics
• ISSN: 2044-6055; 2044-6055
• DOI: 10.1136/bmjopen-2021-050110

ObjectivesTo 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.DesignA multicentre, double-blind, placebo-controlled, pilot randomised trial with nested qualitative evaluation.SettingFive inner city UK National Health Service hospitalsParticipantsMultiethnic pregnant women at 12+0 and 15+6 weeks’ gestation with risk factors for gestational diabetes.Interventions2 g of myo-inositol or placebo, both included 200 µg folic acid, twice daily until delivery.Primary outcome measuresRates of recruitment, randomisation, adherence and follow-up.Secondary outcome measuresGlycaemic 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.ResultsOf 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.ConclusionsA 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 numberISRCTN48872100.