Monitoring glucose levels in women with gestational diabetes during labor
Glucose Monitoring for A1GDM
This study tests if checking blood sugar levels more often during labor helps improve the health of newborns for women with gestational diabetes.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 100 (estimated) |
| Ages | 18 Years to 51 Years |
| Sex | Female |
| Sponsor | Icahn School of Medicine at Mount Sinai Academic / other |
| Locations | 1 site (New York, New York) |
| Trial ID | NCT06744621 on ClinicalTrials.gov |
What this trial studies
This observational study compares frequent glucose monitoring using a single fingerstick upon admission to infrequent monitoring every four hours during latent labor and every two hours during active labor in patients with diet-controlled gestational diabetes mellitus (GDM). The primary objective is to assess the glucose levels of newborns at birth, while secondary objectives include evaluating insulin requirements, NICU admissions, and neonatal blood glucose concentrations at 24 hours of life. The study also considers various demographic factors such as BMI, race, age, and parity to understand their impact on outcomes.
Who should consider this trial
Good fit: Ideal candidates are women aged 18-51 with diet-controlled gestational diabetes who are in labor or being induced.
Not a fit: Patients with elevated admission glucose levels above 120 will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved monitoring strategies for glucose levels during labor, potentially enhancing neonatal outcomes.
How similar studies have performed: While similar studies have explored glucose monitoring in labor, this specific approach comparing frequent versus infrequent monitoring is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * All female patients of reproductive age (menarche-menopause: 18-51 years) who have the diagnosis diet controlled GDM * Patient with singleton gestation presenting in labor or for induction * Patients who had "good" glucose control and were A1GDM. Good Control; * - Patient with overall outpatient glucose average of less than 100 * - No evidence of fetopathy, large for gestational age or polyhydramnios. * - Hgb A1c \<5.7 Exclusion Criteria: • If patient's admission accu check is \>120
Where this trial is running
New York, New York
- Mount Sinai West — New York, New York, United States (Recruiting)
Study contacts
- Principal investigator: Thomas Owens, MD — Mount Sinai West
- Study coordinator: Thomas Owens, MD
- Email: thomas.owens@mountsinai.org
- Phone: 212-523-8110
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.