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 @ 9:13 PM
Ignite Modification Date:
2025-12-24 @ 9:13 PM
NCT ID:
NCT06125704
Eligibility Criteria:
Eligibility Criteria
* Singleton, viable pregnancy with low suspicion for clinically significant abnormality or aneuploidy
* Age 18-40 years (at recruitment)
* Comfortable communicating with study staff in English and completing study surveys in English (i.e., no translator needed)
* Identified as Gestational Glucose Intolerance (GGI) and a 3-hr 100g OGTT for Gestational Diabetes Mellitus (GDM) performed ≥ 24 weeks (i.e., GGI or GDM), or GDM by the one step procedure or a 1-hr 50-g glucose challenge test (GCT) ≥ 180 mg/dl performed ≥ 24 weeks
Identification of GGI 1-hr 50-g GCT (non-fasting), with plasma glucose at 1-hr ≥ 130 mg/dL
Identification of GDM by the two-step procedure
Identified as GGI, followed by a 3-hr 100g OGTT at ≥ 24 weeks after an overnight fast, with at least two of four plasma glucose values meeting or exceeding:
* Fasting: 95 mg/dL
* 1-hr: 180 mg/dL
* 2-hr: 155 mg/dL
* 3-hr: 140 mg/dl
Identification of GDM by the one-step procedure 75-g OGTT at ≥ 24 weeks after an overnight fast, with at least one plasma glucose value meeting or exceeding:
* Fasting: 92 mg/dL
* 1-hr: 180 mg/dL
* 2-hr: 153 mg/dL
Identification of GDM by 1-hr 50-g GCT
1-hr 50-g GLT (non-fasting), with plasma glucose at 1-hr ≥ 180 mg/dL at ≥ 24 weeks
Exclusion Criteria
* Indication that physical activity is or should be limited in the current pregnancy
* Previously diagnosed with diabetes (i.e., Type I or Type II diabetes) outside of pregnancy
* Current use of daily medications known to alter insulin resistance and/or metabolic profiles (e.g., metformin, corticosteroids, anti-psychotics)
* Current use of medication for polycystic ovarian syndrome (PCOS) (i.e., history of PCOS okay as long as she is not currently taking medication for PCOS)
* Condition or circumstance that would preclude their ability to follow a strict, time-based study protocol (e.g., psychiatric illness).
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
40 Years
Study:
NCT06125704
Study Brief:
Protocol Section:
NCT06125704