Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Intrapartum Glucose Management Among Women With Gestational Diabetes Mellitus

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02596932
Recruitment Status : Completed
First Posted : November 4, 2015
Last Update Posted : January 7, 2019
Sponsor:
Information provided by (Responsible Party):
Maureen Hamel, Women and Infants Hospital of Rhode Island

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.

Condition or disease Intervention/treatment Phase
Gestational Diabetes Mellitus Other: Standard Protocol for intrapartum glucose management Other: Experimental Protocol for intrapartum glucose management Not Applicable

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.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 76 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Intrapartum Glucose Management Among Women With Gestational Diabetes Mellitus and Its Impact on Neonatal Blood Glucose Levels
Study Start Date : February 2016
Actual Primary Completion Date : December 2018
Actual Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Blood Sugar
Drug Information available for: Dextrose

Arm Intervention/treatment
Tight control

Intervention Standard Care:

Tight glucose control protocol: Goal maternal blood glucose 70-100, q 1 hour blood glucose checks, insulin treatment started with single maternal blood glucose level > 100mg/dL or < 60 mg/dL

Other: Standard Protocol for intrapartum glucose management
Tight glucose control protocol: Goal maternal blood glucose 70-100, q 1 hour blood glucose checks, insulin treatment started with single maternal blood glucose level > 100mg/dL or < 60mg/dL
Other Name: Tight Control

Experimental: Less tight control

Intervention:

Less Tight glucose control protocol: Goal maternal blood glucose 70-120, q 4 hour blood glucose checks (unless symptomatic), insulin treatment started with single maternal blood glucose > 120 mg/dL or < 60mg/dL

Other: Experimental Protocol for intrapartum glucose management
Less Tight: Goal maternal blood glucose 70-120, q 4 hour blood glucose checks (unless symptomatic), insulin treatment started with single maternal blood glucose > 120 mg/dL or < 60 mg/dL
Other Name: Less Tight Control




Primary Outcome Measures :
  1. Mean neonatal blood glucose levels [ Time Frame: 24 hours ]

Secondary Outcome Measures :
  1. Neonatal Intensive Care Unit (NICU) admission [ Time Frame: Birth of neonate until time of discharge of neonate to home up to 7 days ]
    Any admission to Neonatal Intensive Care Unit from moment of birth of neonate until time of discharge of neonate to home

  2. Hours in Neonatal Intensive Care Unit (NICU) [ Time Frame: Birth of neonate until time of discharge of neonate to home up to 7 days ]
    Any time spent in Neonatal Intensive Care Unit from moment of birth of neonate until time of discharge of neonate to home

  3. Maternal hypoglycemia [ Time Frame: Intrapartum period ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02596932


Locations
Layout table for location information
United States, Rhode Island
Women & Infants Hospital Rhode Island
Providence, Rhode Island, United States, 02905
Sponsors and Collaborators
Women and Infants Hospital of Rhode Island
Investigators
Layout table for investigator information
Principal Investigator: Maureen S Hamel, MD Maternal Fetal Medicine

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Maureen Hamel, Maureen S. Hamel MD, Women and Infants Hospital of Rhode Island
ClinicalTrials.gov Identifier: NCT02596932     History of Changes
Other Study ID Numbers: 809018
First Posted: November 4, 2015    Key Record Dates
Last Update Posted: January 7, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Maureen Hamel, Women and Infants Hospital of Rhode Island:
Intrapartum
Additional relevant MeSH terms:
Layout table for MeSH terms
Diabetes, Gestational
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Pregnancy Complications
Insulin
Insulin, Globin Zinc
Hypoglycemic Agents
Physiological Effects of Drugs