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 @ 7:32 PM
Ignite Modification Date:
2025-12-24 @ 7:32 PM
NCT ID:
NCT03957603
Eligibility Criteria:
Inclusion Criteria:
* Gestational age between 24 and 28 weeks of gestation
* Age \>= 18 years
* Singleton pregnancy
* Two of three or three results of the oral glucose tolerance test (OGTT) are above the diagnostic criteria. (The diagnostic criteria for three results of OGTT: Fasting plasma glucose ≥ 5.1mmol/L, 1-hour OGTT plasma glucose ≥ 10.0mmol/L, 2-hour OGTT plasma glucose ≥ 8.5mmol/L)
Exclusion Criteria:
* History of prenatal hypertension, diabetes, hyperlipidemias, liver disease, kidney disease, digestive tract disease and infectious disease (hepatitis, tuberculosis etc.)
* Gestational weeks \< 24 or \> 28
* Age \< 18 years or Age \> 45 years
* Multiple pregnancy
* Food allergic history
* Regular smoking, drinking alcohol
* Patients with the history of using the assisted reproductive technology
* Patients with psychiatric disorders that prevents correctly answer the questions
* Patients who are unable to answer the questionnaire questions
* Bariatric surgery history
* Non-adherence of dietary and lifestyle recommendation
* Threatened abortion
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
45 Years
Study:
NCT03957603
Study Brief:
Protocol Section:
NCT03957603