Antenatal Myo-inositol Supplementation in Pre-existing Diabetes to Promote Normal Neonatal Outcomes (AMulet)

NCT07241221 NA RECRUITING

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.

Details

Lead sponsor	National University Hospital, Singapore
Phase	NA
Status	RECRUITING
Enrolment	182
Start date	2025-12
Completion	2029-08-31

Conditions

• Perinatal and Neonatal Outcomes in Pregnancies With Type 2 Diabetes Mellitus (T2DM)

Interventions

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

Primary outcomes

• Composite of fetal/neonatal wellbeing — From birth until 4 weeks post-delivery
  Number and proportion of cases displaying all of the following outcomes of (1) being appropriately-grown-for-gestational-age (AGA; 10th-90th centile in weight) at birth; (2) delivered at term (37 weeks+0 days gestation or more); (3) no admission to the neonatal unit in the first 4 weeks of life; and (4) alive at delivery and at 4 weeks post-delivery. Results will also be presented as a relative risk with 95% confidence intervals, with and without adjustment for important covariates, as well as with and without stratification for baseline HbA1C (high/low), pre-pregnancy insulin treatment, duration since T2DM diagnosis (\<1y, \>1y), and in per-protocol analyses.

Countries

Singapore