Clinical trial NCT02596932: Intrapartum Glucose Management Among Women With Gestational Diabetes Mellitus
Official title: Intrapartum Glucose Management Among Women With Gestational Diabetes Mellitus and Its Impact on Neonatal Blood Glucose Levels
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gestational Diabetes Mellitus
Keywords: Intrapartum
Lead sponsor: Women and Infants Hospital of Rhode Island
Sponsor class: OTHER
First posted: 2015-11-04
Enrollment: 76
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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)

Primary outcomes:
measure: Mean neonatal blood glucose levels
timeFrame: 24 hours
Secondary outcomes:
measure: Neonatal Intensive Care Unit (NICU) admission
timeFrame: Birth of neonate until time of discharge of neonate to home up to 7 days
measure: Hours in Neonatal Intensive Care Unit (NICU)
timeFrame: Birth of neonate until time of discharge of neonate to home up to 7 days
measure: Maternal hypoglycemia
timeFrame: Intrapartum period
Other outcomes:
Locations:
city: Providence
country: United States
facility: Women & Infants Hospital Rhode Island
state: Rhode Island
Study officials:
affiliation: Maternal Fetal Medicine
name: Maureen S Hamel, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hamel MS, Kanno LM, Has P, Beninati MJ, Rouse DJ, Werner EF. Intrapartum Glucose Management in Women With Gestational Diabetes Mellitus: A Randomized Controlled Trial. Obstet Gynecol. 2019 Jun;133(6):1171-1177. doi: 10.1097/AOG.0000000000003257.