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:
2026-03-26 @ 3:14 PM
Ignite Modification Date:
2026-03-26 @ 3:14 PM
NCT ID:
NCT07436195
Eligibility Criteria:
Inclusion Criteria:
* Pregnant women between 20 and 28 weeks of gestation
* The father of the child is known and willing to participate in the study
* No known underlying medical conditions in either parent
* No fetal abnormalities detected in first-trimester screening, detailed fetal anatomy ultrasound, non-invasive prenatal testing (NIPT), or any additional prenatal examinations performed, if applicable
* No known underlying diseases
* Understanding and voluntary signing of a consent form before study- related examinations
Exclusion Criteria:
* Age \< 18 years
* Type 1 or type 2 diabetes mellitus
* Pharmacological treatment affecting blood glucose levels (e.g., steroids, insulin)
* Endocrine disorders (e.g., hyperthyroidism, polycystic ovary syndrome \[PCOS\])
* Current depression or other psychiatric disorders
* Eating disorders
* Regular use of medication during pregnancy
* Pre-existing cardiovascular disease
* Drug and/or alcohol abuse
* 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
* 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:
ALL
Minimum Age:
18 Years
Study:
NCT07436195
Study Brief:
Protocol Section:
NCT07436195