Neonatal Hypoglycemia Clinical Trial
Official title:
Intrapartum Glucose Monitoring of GDM: A Randomized Controlled Trial
The aim of this study is to assess rates of neonatal hypoglycemia with differing intrapartum glucose protocols. Currently at this time there is no guidance from professional medical organizations about when and how frequent to assess maternal glucose levels intrapartum. Several institutions have no protocols in place. The study will be a randomized controlled trial placing patients with Gestational Diabetes Mellitus (GDM) in "frequent" vs "infrequent" glucose monitoring intrapartum and assessing neonatal glucose levels at birth.
| Status | Not yet recruiting |
| Enrollment | 160 |
| Est. completion date | November 26, 2024 |
| Est. primary completion date | November 26, 2024 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | Female |
| Age group | 18 Years and older |
| Eligibility | 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 |
| Country | Name | City | State |
|---|---|---|---|
| United States | Mount Sinai West Hospital | New York | New York |
| Lead Sponsor | Collaborator |
|---|---|
| Icahn School of Medicine at Mount Sinai |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Neonatal Hypoglycemia | Glucose values of neonate measured in mg/dL | end of study at 6 months |
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