Antenatal Myo-inositol Supplementation in Pre-existing Diabetes
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age21-45
SponsorNational University Hospital, Singapore
About this trial
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
Known or suspected fetal aneuploidy or genetic/structural anomaly
Severe allergy to food items requiring carriage of an Epipen at all times
Trial design
Treatments tested in this trial
- Myo-inositol and folic acid supplement
- Folic acid supplement
Treatment groups
182 Participants
are divided into 2 treatment groupsSponsors and collaborators
National University Hospital, Singapore
Lead sponsor
National University of Singapore
Collaborator
Source ClinicalTrials.gov