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New treatment option for Perinatal and Neonatal Outcomes in Pregnancies With Type 2 Diabetes...
Official title Antenatal Myo-inositol Supplementation in Pre-existing Diabetes
ClinicalTrials.gov ID: NCT07241221
What this study is testing
- What it's testing
- 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.
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 21 to 45, women only
You may be able to join if
- 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...
- Intend to receive antenatal care and give birth at NUH
You likely can't join if
- Known or suspected fetal aneuploidy or genetic/structural anomaly
- Severe allergy to food items requiring carriage of an Epipen at all times
See the full eligibility 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...
- 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
- Known or suspected fetal aneuploidy or genetic/structural anomaly
- Severe allergy to food items requiring carriage of an Epipen at all times
The study team makes the final eligibility decision.
Where it's taking place
- Singapore, Singapore, Singapore
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 21 years to 45 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Singapore, Singapore, Singapore. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.