TY - JOUR
T1 - Myo-inositol nutritional supplement for prevention of gestational diabetes (EMmY)
T2 - a randomised, placebo-controlled, double-blind pilot trial with nested qualitative study
AU - Amaefule, Chiamaka Esther
AU - Drymoussi, Zoe
AU - Gonzalez Carreras, Francisco Jose
AU - Pardo Llorente, Maria Del Carmen
AU - Lanz, Doris
AU - Dodds, Julie
AU - Sweeney, Lorna
AU - Pizzo, Elena
AU - Thomas, Amy
AU - Heighway, James
AU - Daru, Jahnavi
AU - Sobhy, Soha
AU - Poston, Lucilla
AU - Khalil, Asma
AU - Myers, Jenny
AU - Harden, Angela
AU - Hitman, Graham
AU - Khan, Khalid Saeed
AU - Zamora, Javier
AU - Pérez, Teresa
AU - Huda, Mohammed S.B.
AU - Thangaratinam, Shakila
N1 - Funding Information:
Funding The EMmY trial is sponsored by Queen Mary University of London and funded by Barts Charity, grant number MGU0373. EP and AH are also supported by the NIHR Collaboration for Leadership in Applied Health Research at Barts Health NHS Foundation Trust (NIHR ARC North Thames). KSK is distinguished investigator funded by the Beatriz Galindo (senior modality) grant to the University of Granada by the Spanish Ministry of Education.
Funding Information:
Twitter Lorna Sweeney @lorna_sweeney, Asma Khalil @profasmakhalil and Khalid Saeed Khan @Profkkhan Acknowledgements The authors acknowledge Pharmasure for the donation of myo-inositol and placebo tablets to the EMmY study and Montuno software for the discounted Dosecast app. The authors are grateful to the patient advisers and site midwives for their contributions towards the study.The EMmY pilot trial was supported by the National Institute for Health Research (NIHR) Programme Grants for Applied Research. The views expressed are those of the authors and not necessarily those of the NHS, the NIHR or the Department of Health and Social Care. KSK is a Distinguished Investigator funded by the Beatriz Galindo (Senior Modality) Programme grant given to the University of Granada by the Ministry of Science, Innovation and Universities of the Spanish Government.
Publisher Copyright:
© 2022 BioMed Central Ltd.. All rights reserved.
PY - 2022/3/11
Y1 - 2022/3/11
N2 - 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 hospitals PARTICIPANTS: 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.
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 hospitals PARTICIPANTS: 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.
KW - diabetes in pregnancy
KW - health economics
KW - maternal medicine
KW - public health
KW - qualitative research
UR - http://www.scopus.com/inward/record.url?scp=85126389519&partnerID=8YFLogxK
U2 - 10.1136/bmjopen-2021-050110
DO - 10.1136/bmjopen-2021-050110
M3 - Article
C2 - 35277398
AN - SCOPUS:85126389519
SN - 2044-6055
VL - 12
SP - e050110
JO - BMJ Open
JF - BMJ Open
IS - 3
M1 - e052788
ER -
