Intrapartum Glucose Management Among Women With Gestational Diabetes Mellitus

NCT ID: NCT02596932

Last Updated: 2019-01-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 76 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-02-29
• Study Completion Date: 2018-12-31

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.

Conditions

Gestational Diabetes Mellitus

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

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

Group Type: OTHER

Standard Protocol for intrapartum glucose management

Intervention Type: OTHER

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

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

Group Type: EXPERIMENTAL

Experimental Protocol for intrapartum glucose management

Intervention Type: OTHER

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

Interventions

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

Intervention Type: 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

Intervention Type: OTHER

Other Intervention Names

Tight Control; Less Tight Control

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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Women and Infants Hospital of Rhode Island

OTHER

Sponsor Role: lead

Responsible Party

Maureen Hamel

Maureen S. Hamel MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Maureen S Hamel, MD

Role: PRINCIPAL_INVESTIGATOR

Maternal Fetal Medicine

Locations

Women & Infants Hospital Rhode Island

Providence, Rhode Island, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 31135731 (View on PubMed)

Other Identifiers

809018

Identifier Type: -

Identifier Source: org_study_id