Intrapartum Glucose Management Among Women With Gestational Diabetes Mellitus

NCT02596932 | Completed

• 1 other identifier: 809018
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 1

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.

Conditions

Gestational Diabetes Mellitus

Keywords

Intrapartum

Outcome Measures

Primary Outcomes (1)

• Mean neonatal blood glucose levels

  24 hours

Secondary Outcomes (3)

• Neonatal Intensive Care Unit (NICU) admission

  Birth of neonate until time of discharge of neonate to home up to 7 days

• Hours in Neonatal Intensive Care Unit (NICU)

  Birth of neonate until time of discharge of neonate to home up to 7 days

• Maternal hypoglycemia

  Intrapartum period

Study Arms (2)

Tight control

OTHER

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

Less tight control

EXPERIMENTAL

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

Interventions

Standard Protocol for intrapartum glucose management 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

Also known as: Tight Control

Tight control

Experimental Protocol for intrapartum glucose management 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

Also known as: Less Tight Control

Less tight control

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Women and Infants Hospital of Rhode Island: lead

Study Sites (1)

Women & Infants Hospital Rhode Island

Providence, Rhode Island, 02905, United States

Location

Related Publications (1)

• 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.

  PMID: 31135731 DERIVED

MeSH Terms

Conditions

Diabetes, Gestational

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Maureen S Hamel, MD

  Maternal Fetal Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Maureen S. Hamel MD

Study Record Dates

• First Submitted: October 31, 2015
• First Posted: November 4, 2015
• Study Start: February 1, 2016
• Primary Completion: December 1, 2018
• Study Completion: December 1, 2018
• Last Updated: January 7, 2019

Record last verified: 2019-01

Locations

US (1)