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dc.contributor.authorAmaefule, Chiamaka Esther
dc.contributor.authorSaeed Khan, Khalid 
dc.date.accessioned2022-04-04T12:12:05Z
dc.date.available2022-04-04T12:12:05Z
dc.date.issued2022-03-11
dc.identifier.citationAmaefule CE... [et al.]. Myo-inositol nutritional supplement for prevention of gestational diabetes (EMmY): a randomised, placebo-controlled, double-blind pilot trial with nested qualitative study. BMJ Open 2022;12:e050110. doi:[10.1136/bmjopen-2021-050110]es_ES
dc.identifier.urihttp://hdl.handle.net/10481/74105
dc.descriptionThe 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.es_ES
dc.description.abstractObjectives 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.es_ES
dc.description.sponsorshipQueen Mary University of Londones_ES
dc.description.sponsorshipBarts Charity MGU0373es_ES
dc.description.sponsorshipNIHR Collaboration for Leadership in Applied Health Research at Barts Health NHS Foundation Trust (NIHR ARC North Thames)es_ES
dc.description.sponsorshipUniversity of Granada by the Spanish Ministry of Educationes_ES
dc.language.isoenges_ES
dc.publisherBMJes_ES
dc.rightsAtribución-NoComercial 3.0 España*
dc.rights.urihttp://creativecommons.org/licenses/by-nc/3.0/es/*
dc.titleMyo-inositol nutritional supplement for prevention of gestational diabetes (EMmY): a randomised, placebo-controlled, double-blind pilot trial with nested qualitative studyes_ES
dc.typeinfo:eu-repo/semantics/articlees_ES
dc.rights.accessRightsinfo:eu-repo/semantics/openAccesses_ES
dc.identifier.doi10.1136/bmjopen-2021-050110
dc.type.hasVersioninfo:eu-repo/semantics/publishedVersiones_ES


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