PT  - JOURNAL ARTICLE
AU  - Chiamaka Esther Amaefule
AU  - Zoe Drymoussi
AU  - Francisco Jose Gonzalez Carreras
AU  - Maria del Carmen Pardo Llorente
AU  - Doris Lanz
AU  - Julie Dodds
AU  - Lorna Sweeney
AU  - Elena Pizzo
AU  - Amy Thomas
AU  - James Heighway
AU  - Jahnavi Daru
AU  - Soha Sobhy
AU  - Lucilla Poston
AU  - Asma Khalil
AU  - Jenny Myers
AU  - Angela Harden
AU  - Graham Hitman
AU  - Khalid Saeed Khan
AU  - Javier Zamora
AU  - Teresa Pérez
AU  - Mohammed S B Huda
AU  - Shakila Thangaratinam
TI  - Myo-inositol nutritional supplement for prevention of gestational diabetes (EMmY): a randomised, placebo-controlled, double-blind pilot trial with nested qualitative study
AID  - 10.1136/bmjopen-2021-050110
DP  - 2022 Mar 01
TA  - BMJ Open
PG  - e050110
VI  - 12
IP  - 3
4099  - http://bmjopen.bmj.com/content/12/3/e050110.short
4100  - http://bmjopen.bmj.com/content/12/3/e050110.full
SO  - BMJ Open2022 Mar 01; 12
AB  - 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.Data are available on reasonable request. Release of data will be subject to a data use agreement between the contractor and the third party requesting the data. The data use agreement must detail the agreed use and appropriate management of the research data to be shared and include a requirement for recognition of the contribution of the researchers who generated the data and the original funder.