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 @ 5:08 PM
Ignite Modification Date:
2025-12-24 @ 5:08 PM
NCT ID:
NCT04407650
Eligibility Criteria:
Inclusion Criteria:
1. Women between 16 and 45 years of age with GDM diagnosed at 26+0 to 30+6 weeks' gestation in accordance with the NICE guidelines (one or more glucose concentrations of ≥5.6 mmol/l fasting or ≥7.8 mmol/l 2 hours after a standard 75g OGTT, and requiring pharmacological treatment).
2. Overweight or obese (Booking BMI ≥25 kg/m2)
3. Planned antenatal, intrapartum and postpartum care at the participating centre (i.e. not planning to move before delivery).
Exclusion Criteria:
1. Unwilling/unable to give written informed consent and comply with the requirements of the study protocol
2. Multiple pregnancies (twins, triplets etc) in current pregnancy
3. Congenital anomaly on ultrasound requiring fetal medicine input
4. Previous diagnosis of diabetes outside pregnancy
5. HbA1c at booking \>48 mmol/mol or ≥6.5% during current pregnancy (if available)
6. Significant pre-pregnancy comorbidities that increase risk in pregnancy, for example renal failure, severe liver disease, transplantation, cardiac failure, psychiatric conditions requiring in-patient admission (within previous year) in the opinion of the responsible clinician or the CI.
7. Significant co-morbidity in the current pregnancy, nephropathy (estimated GFR \<60ml/min), other physical or psychological conditions likely to interfere with the conduct of the study and/or interpretation of the trial results in the opinion of the responsible clinician or the CI.
8. Not fluent in English and absence of interpreter or translation services (ie telephone translation services)
9. Participating in another intervention study where the results could influence GDM-related endpoints, in the opinion of the responsible clinician or the CI, or participation in a CTIMP during current pregnancy.
10. Known allergy/hypersensitivity/intolerance to the active substance or excipients, or patients taking any medications which are contraindicated as per IMP SmPC
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
16 Years
Maximum Age:
45 Years
Study:
NCT04407650
Study Brief:
Protocol Section:
NCT04407650