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Antenatal Myo-inositol Supplementation in Pre-existing Diabetes

RecruitingNAAges 21 Years - 45 YearsFemaleNational University Hospital, Singapore
NCT07241221 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

This feasibility pilot study aims to gather data that can guide the design of a larger, more comprehensive trial to establish the effects of myo-inositol supplementation on supporting healthy outcomes in pregnancies complicated by Type 2 Diabetes Mellitus (T2DM). It seeks to assess myo-inositol's potential to support fetal and neonatal health, and optimise maternity outcomes as a complementary approach and adjuvant to existing diabetes mellitus therapies, as well as investigate the underlying biological mechanisms.

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📋 Eligibility rules (as published)
Inclusion Criteria * Pregnant women aged 21 years to 45 years old at the time of recruitment * Ongoing, viable, singleton intrauterine pregnancy * Between 12+0 days-16+6 days weeks' gestation at recruitment * T2DM diagnosed by a documented 75g Oral Glucose Tolerance Test (OGTT) showing a fasting glucose of \>7 mmol/L or 2h glucose \>11.1 mmol/L, or an HbA1C \>6.5%, either prior to pregnancy or during the first 16 weeks of the index pregnancy * Intend to receive antenatal care and give birth at NUH * Willing to provide written, informed consent * Able to swallow capsules and comply with trial procedures Exclusion Criteria * Known or suspected fetal aneuploidy or genetic/structural anomaly * Severe allergy to food items requiring carriage of an Epipen at all times
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What it tests

  • Myo-inositol and folic acid supplement
  • Folic acid supplement
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Where

1 site
National University Hospital
Singapore, Singapore
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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