Evidence map›Paper›PMID 35277398›Full record

Trial reportBMJ open2022

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

Chiamaka Esther Amaefule, Zoe Drymoussi, Francisco Jose Gonzalez Carreras, Maria Del Carmen Pardo Llorente, Doris Lanz, Julie Dodds, Lorna Sweeney, Elena Pizzo, Amy Thomas, James Heighway and 12 more

Registry-linked trialOpen access · goldAbstract readMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in BMJ open, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT06575868 (Continuous Glucose Monitoring in Myo-inositol Supplemented Obese Pregnant Individuals), which is not on this map. Cited by 9 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
9citing papers in PubMed, 1 pooled it
1.5field-weighted citation impact, top 19% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT06575868 narecruitingnot on this mapstarted 2025, after this paper: background citation

Continuous Glucose Monitoring in Myo-inositol Supplemented Obese Pregnant Individuals: a Feasibility Pilot Randomized Control Trial

TypeinterventionalSponsorTufts Medical CenterRan2025 to 2027Enrolled40ConditionsPregnancy RelatedArmsMyo-inositol, Myo-inositol placebo
3 · Its place in the literature

Who cites it

9 citing papers in PubMed, 1 synthesis or guideline pooled it, 9 citations in OpenAlex.

  1. Pooled it
  2. Trial
  3. Review
  4. Article
  5. Article
  6. Article
  7. Article
  8. Review
  9. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

22 authors at 11 institutions in 2 countries.

Chiamaka Esther AmaefuleBARC (Barts Research Centre for Women's Health), Institute of Population Health Sciences, Queen Mary University of London Barts and The London School of Medicine and Dentistry, London, UK.ORCID 0000-0003-3864-2642
Zoe DrymoussiBARC (Barts Research Centre for Women's Health), Institute of Population Health Sciences, Queen Mary University of London Barts and The London School of Medicine and Dentistry, London, UK.ORCID 0000-0001-6683-9114
Francisco Jose Gonzalez CarrerasBARC (Barts Research Centre for Women's Health), Institute of Population Health Sciences, Queen Mary University of London Barts and The London School of Medicine and Dentistry, London, UK.
Maria Del Carmen Pardo LlorenteDepartment of Statistics and Operational Research, Complutense University of Madrid, Madrid, Spain.
Doris LanzBARC (Barts Research Centre for Women's Health), Institute of Population Health Sciences, Queen Mary University of London Barts and The London School of Medicine and Dentistry, London, UK.
Julie DoddsBARC (Barts Research Centre for Women's Health), Institute of Population Health Sciences, Queen Mary University of London Barts and The London School of Medicine and Dentistry, London, UK.
Lorna SweeneyInstitute for Health and Human Development, University of East London, London, UK.ORCID 0000-0002-1630-467X
Elena PizzoNIHR ARC (Applied Health Collaborations) for North Thames London, Department of Applied Health Research, University College London, London, UK.
Amy ThomasBARC (Barts Research Centre for Women's Health), Institute of Population Health Sciences, Queen Mary University of London Barts and The London School of Medicine and Dentistry, London, UK.
James HeighwayBARC (Barts Research Centre for Women's Health), Institute of Population Health Sciences, Queen Mary University of London Barts and The London School of Medicine and Dentistry, London, UK.
Jahnavi DaruBARC (Barts Research Centre for Women's Health), Institute of Population Health Sciences, Queen Mary University of London Barts and The London School of Medicine and Dentistry, London, UK.ORCID 0000-0001-5816-2609
Soha SobhyBARC (Barts Research Centre for Women's Health), Institute of Population Health Sciences, Queen Mary University of London Barts and The London School of Medicine and Dentistry, London, UK.
Lucilla PostonDepartment of Women and Children's Health, Faculty of Life Sciences and Medicine, King's College London, London, UK.
Asma KhalilDepartment of Obstetrics and Gynaecology, St George's Hospital, London, UK.
Jenny MyersMaternal and Fetal Health Research Centre, Manchester Academic Health Science Centre, The University of Manchester, Manchester, UK.
Angela HardenInstitute for Health and Human Development, University of East London, London, UK.
Graham HitmanCentre for Genomics and Child Health, Blizard Institute, Queen Mary University of London, Barts and The London School of Medicine and Dentistry, London, UK.
Khalid Saeed KhanDepartment of Preventive Medicine and Public Health, Universidad de Granada, Granada, Spain.ORCID 0000-0001-5084-7312
Javier ZamoraClinical Biostatistics Unit and CIBER Epidemiology and Public Health, IRYCIS, Madrid, Spain.
Teresa PérezBARC (Barts Research Centre for Women's Health), Institute of Population Health Sciences, Queen Mary University of London Barts and The London School of Medicine and Dentistry, London, UK.ORCID 0000-0003-0439-8952
Mohammed S B HudaBarts Health NHS Trust, The Royal London Hospital, Department of Diabetes and Metabolism, London, UK.
Shakila ThangaratinamWHO Collaborating Centre for Global Women's Health, Institute of Metabolism and Systems Research, University of Birmingham, Birmingham, UK s.thangaratinam.1@bham.ac.uk.
Queen Mary University of London · GBUniversidad Complutense de Madrid · ESUniversity of East London · GBBarts Health NHS Trust · GBBirmingham Women’s and Children’s NHS Foundation Trust · GBInstituto Ramón y Cajal de Investigación Sanitaria · ESKing's College London · GBManchester Academic Health Science Centre · GBNational Institute for Health Research · GBSt George's, University of London · GBUniversidad de Granada · ES

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

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 hospitals

participantsMultiethnic pregnant women at 12

interventions2 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.

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 NUMBER: ISRCTN48872100.

Indexed as

Diabetes, GestationalInsulin ResistanceDouble-Blind MethodFemaleHumansInositolMalePilot ProjectsPregnancyState MedicineInositoldiabetes in pregnancyhealth economicsmaternal medicinepublic healthqualitative research

Identifiers

PMID35277398
PMCPMC8919454
OpenAlexW4220773696

What OpenQuestion holds

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LicenceCC BY
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.