RT Journal Article
SR Electronic
T1 Myo-inositol nutritional supplement for prevention of gestational diabetes (EMmY): a randomised, placebo-controlled, double-blind pilot trial with nested qualitative study
JF BMJ Open
JO BMJ Open
FD British Medical Journal Publishing Group
SP e050110
DO 10.1136/bmjopen-2021-050110
VO 12
IS 3
A1 Chiamaka Esther Amaefule
A1 Zoe Drymoussi
A1 Francisco Jose Gonzalez Carreras
A1 Maria del Carmen Pardo Llorente
A1 Doris Lanz
A1 Julie Dodds
A1 Lorna Sweeney
A1 Elena Pizzo
A1 Amy Thomas
A1 James Heighway
A1 Jahnavi Daru
A1 Soha Sobhy
A1 Lucilla Poston
A1 Asma Khalil
A1 Jenny Myers
A1 Angela Harden
A1 Graham Hitman
A1 Khalid Saeed Khan
A1 Javier Zamora
A1 Teresa Pérez
A1 Mohammed S B Huda
A1 Shakila Thangaratinam
YR 2022
UL http://bmjopen.bmj.com/content/12/3/e050110.abstract
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.