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 @ 6:56 PM
Ignite Modification Date:
2025-12-24 @ 6:56 PM
NCT ID:
NCT01818557
Eligibility Criteria:
Inclusion Criteria:
* Gestational age between 20 weeks 0 days and 32 weeks 0 days of gestation.
* Singleton pregnancies
* Maternal age over 18 years
* Patients able to read and write in English or Spanish,
* Diagnosis of gestational diabetes mellitus using criteria supported by the American College of Obstetrics and Gynecology (ACOG).
* Patients identified as not requiring medical therapy (insulin or glyburide) after the first week of initial blood glucose monitoring.
Exclusion Criteria:
* Diagnosis of GDM made by any method or criteria other than the one outlined above
* Women with pre-existing diabetes mellitus
* Patients under the age of 18 years
* Patients known to be carrying a fetus with a fetal anomaly that requires either prenatal or postnatal surgery, requires early delivery or is at risk for intrauterine growth restriction (IUGR)
* Patients carrying multiple gestations
* Patients with past history of gastric bypass
* Patients with poorly controlled asthma, defined as the need for oral/inhaled corticosteroids to control symptoms
* Patients with chronic hypertension requiring medical therapy
* Patients currently on methadone/suboxone therapy
* Patients currently on any steroid therapy, regardless of the dose or route of administration
* Patients demonstrating poor compliance during the first week of initial blood glucose monitoring, defined as \<20% of expected values actually recorded during the one-week period of initial monitoring
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
55 Years
Study:
NCT01818557
Study Brief:
Protocol Section:
NCT01818557