Intrapartum Glucose Management Among Women With Gestational Diabetes Mellitus
| Status: | Completed |
|---|---|
| Conditions: | Diabetes |
| Therapuetic Areas: | Endocrinology |
| Healthy: | No |
| Age Range: | 18 - 45 |
| Updated: | 1/9/2019 |
| Start Date: | February 2016 |
| End Date: | December 2018 |
Intrapartum Glucose Management Among Women With Gestational Diabetes Mellitus and Its Impact on Neonatal Blood Glucose Levels
Gestational Diabetes Mellitus (GDM) is one of the most common medical complications of
pregnancy. Neonatal hypoglycemia is a common and well described complication for infants born
to mothers with GDM and diabetes mellitus (DM) and studies have linked intrapartum maternal
glucose levels with neonatal hypoglycemia. While guidelines exist to guide practitioners in
how to best manage intrapartum maternal glucose levels among Type I and and Type II DM, there
is a paucity of data guiding practitioners in the intrapartum management of blood glucose
levels for women with GDM, particularly those treated with insulin antepartum. The goal of
this project is to compare two protocols of intrapartum glucose management in women with GDM
and investigate the impact on neonatal blood glucose levels.
pregnancy. Neonatal hypoglycemia is a common and well described complication for infants born
to mothers with GDM and diabetes mellitus (DM) and studies have linked intrapartum maternal
glucose levels with neonatal hypoglycemia. While guidelines exist to guide practitioners in
how to best manage intrapartum maternal glucose levels among Type I and and Type II DM, there
is a paucity of data guiding practitioners in the intrapartum management of blood glucose
levels for women with GDM, particularly those treated with insulin antepartum. The goal of
this project is to compare two protocols of intrapartum glucose management in women with GDM
and investigate the impact on neonatal blood glucose levels.
Research objective- To compare "Tight" vs. "Less Tight" intrapartum glucose management
Hypothesis: Neonates born to mothers managed via the "Less Tight" intrapartum glucose
management protocol will have lower mean glucose levels in the first 24 hours of life when
compared to mean glucose levels among infants born to mothers managed via the "Tight"
intrapartum glucose management protocol.
Study Design: Randomized trial
Population: English or Spanish speaking women with a diagnosis of GDM managed at the Diabetes
in Pregnancy Program at Women & Infants Hospital, with a plan to deliver at Women & Infants
Hospital
Once enrolled, patients will then be randomized to "Tight" or "Less Tight" intrapartum
glucose control.
Once admitted to the labor floor for intrapartum management the appropriate power plan for
glucose control will be initiated. The specifics of labor management will be left to the
discretion of the provider.
Hypothesis: Neonates born to mothers managed via the "Less Tight" intrapartum glucose
management protocol will have lower mean glucose levels in the first 24 hours of life when
compared to mean glucose levels among infants born to mothers managed via the "Tight"
intrapartum glucose management protocol.
Study Design: Randomized trial
Population: English or Spanish speaking women with a diagnosis of GDM managed at the Diabetes
in Pregnancy Program at Women & Infants Hospital, with a plan to deliver at Women & Infants
Hospital
Once enrolled, patients will then be randomized to "Tight" or "Less Tight" intrapartum
glucose control.
Once admitted to the labor floor for intrapartum management the appropriate power plan for
glucose control will be initiated. The specifics of labor management will be left to the
discretion of the provider.
Inclusion Criteria:
- English or Spanish speaking women with a diagnosis of GDM managed at the Diabetes in
Pregnancy Program at Women & Infants Hospital, with a plan to deliver at Women &
Infants Hospital
Exclusion Criteria:
- Pre-existing DM, multiple gestations, major fetal anomalies anticipated to require
NICU admission, planned cesarean delivery, medications known to effect glucose
metabolism other than insulin (i.e. metformin)
We found this trial at
1
site
101 Dudley St
Providence, Rhode Island 02905
Providence, Rhode Island 02905
(401) 274-1100
Principal Investigator: Maureen S Hamel, MD
Phone: 508-479-9190
Women and Infants Hospital of Rhode Island Women & Infants Hospital of Rhode Island, a...
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