Early Screening for Gestational Diabetes Mellitus in a Low Risk Population (NCT06704035) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Early Screening for Gestational Diabetes Mellitus in a Low Risk Population
Singapore120 participantsStarted 2024-12-01
Plain-language summary
This new feasibility pilot study aims to refine the design and protocols for a larger trial that will investigate the potential benefits of early oral glucose tolerance test (OGTT) screening in a population traditionally defined as low-risk for development of gestational diabetes. The study will evaluate its potential effectiveness in reducing the risks of neonatal morbidity/mortality and obstetric complications. Additionally, a machine learning algorithm to predict gestational diabetes mellitus (GDM) risk based on routinely obtained clinical information at pregnancy booking, and minimally invasive methods, such as continuous glucose monitoring (CGM) and gingival crevicular fluid (GCF) sampling, are being explored to predict the risk of hyperglycaemia. This study aims to investigate the utility of early pregnancy screening to enable timely detection and management of early gestational diabetes development in a low-risk population, ultimately promoting better health outcomes for mothers and their babies.
Who can participate
Age range21 Years – 39 Years
SexFEMALE
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Inclusion criteria
✓. Pregnant women aged 21-39 years at recruitment
✓. Singleton pregnancy
✓. Less than 16 weeks pregnant at recruitment
✓. Intend to receive antenatal care and give birth at the National University Hospital
Exclusion criteria
✕. Known pre-existing type 1 or type 2 diabetes mellitus at recruitment
✕. Classified as high-risk for GDM at pregnancy booking using the traditional checklist:
✕.1) Age ≥40 years 2.2) Overweight/obese, i.e., body mass index (BMI) ≥25.0 kg/m2 2.3) First degree relative with diabetes mellitus 2.4) Previously delivered a baby ≥4 kg 2.5) Previously diagnosed with GDM 2.6) Impaired glucose tolerance (IGT) or impaired fasting glycaemia (IFG) on previous testing 2.7) Polycystic ovarian syndrome (PCOS) 2.8) Poor obstetric history (e.g. recurrent pregnancy loss, previous intrauterine death, congenital malformations) 2.9) History of chronic hypertension, hyperlipidaemia or cardiovascular disease 2.10) Glycosuria ≥ 2+ on urine dipstick
✕
What they're measuring
1
Composite of perinatal/neonatal morbidity/mortality