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:
2025-12-25 @ 3:26 AM
Ignite Modification Date:
2025-12-25 @ 3:26 AM
NCT ID:
NCT06170905
Eligibility Criteria:
Inclusion Criteria:
* Pregnant women between 24+0 and 27+6 (+/- 7 days) weeks of pregnancy after menstruation
* BMI before pregnancy: 18 - 29.9 kg/m2
* No known underlying diseases
* Understanding and voluntary signing of a consent form before study-related examinations
Exclusion Criteria:
* Age \< 18 years
* Diabetes mellitus type 1 or type 2
* Drug therapy that raises or lowers blood sugar, e.g. steroids, antidiabetics, insulin.
* Endocrine disorders (e.g. hyperthyroidism, polycystic ovary syndrome (PCOS), ...)
* Current depression or other mental illnesses
* Eating disorder
* Regular intake of medication other than vitamins/trace elements during pregnancy
* Estimated glomerular filtration rate (eGFR) \< 60 ml/min/1.73 m²
* C-reactive protein \> 10 mg/l
* Transaminase elevation of 2 times the upper norm
* Pre-existing cardiac diseases
* Drug and/or alcohol abuse
* Hb \< 12 g/dl
* No consent to be informed about incidentally discovered pathological findings
* Any other (clinical) condition that would endanger participants safety or question scientific success according to the physicians opinion.
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT06170905
Study Brief:
Protocol Section:
NCT06170905