Assessing glucose monitoring frequency during labor for mothers with gestational diabetes
Intrapartum Glucose Monitoring of GDM: a Randomized Controlled Trial
This study is testing whether checking blood sugar levels more often during labor can help newborns of mothers with gestational diabetes avoid low blood sugar problems.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 300 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Icahn School of Medicine at Mount Sinai Academic / other |
| Locations | 1 site (New york, New York) |
| Trial ID | NCT06373432 on ClinicalTrials.gov |
What this trial studies
This study evaluates the impact of different glucose monitoring frequencies during labor on neonatal hypoglycemia rates in mothers diagnosed with Gestational Diabetes Mellitus (GDM). Participants will be randomly assigned to either a 'frequent' or 'infrequent' glucose monitoring group during labor. The study aims to establish a protocol for glucose monitoring that could improve neonatal outcomes by assessing glucose levels at birth. Currently, there are no standardized guidelines for monitoring maternal glucose levels during labor, making this research particularly relevant.
Who should consider this trial
Good fit: Ideal candidates for this study are female patients of reproductive age diagnosed with Gestational Diabetes Mellitus who are presenting in labor or for induction.
Not a fit: Patients who are under 18 years of age, have multiple gestations, or are undergoing scheduled cesarean sections may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved protocols for glucose monitoring during labor, potentially reducing the incidence of neonatal hypoglycemia.
How similar studies have performed: While there is limited guidance on this specific approach, similar studies assessing glucose monitoring protocols have shown promise in improving maternal and neonatal outcomes.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * All female patients of reproductive age who have the diagnosis GDM * Patient with singleton gestation presenting in labor or for induction Exclusion Criteria: * Patients below the age of 18 * Multiple gestation pregnancy * Patients undergoing scheduled c-section
Where this trial is running
New york, New York
- Mount Sinai West Hospital — New york, New York, United States (Recruiting)
Study contacts
- Principal investigator: Thomas Owens, MD — Icahn School of Medicine at Mount Sinai
- 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.