Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 10:33 PM
Ignite Modification Date:
2025-12-24 @ 10:33 PM
NCT ID:
NCT06704035
Eligibility Criteria:
Inclusion Criteria:
1. Pregnant women aged 21-39 years at recruitment
2. Singleton pregnancy
3. Less than 16 weeks pregnant at recruitment
4. Intend to receive antenatal care and give birth at the National University Hospital
Exclusion Criteria:
1. Known pre-existing type 1 or type 2 diabetes mellitus at recruitment
2. Classified as high-risk for GDM at pregnancy booking using the traditional checklist:
2.1) 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
3. Taking systemic steroid medication or metformin
4. Participation in another intervention trial
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
21 Years
Maximum Age:
39 Years
Study:
NCT06704035
Study Brief:
Protocol Section:
NCT06704035