Skip to main content
OpenTrials
Completed

NCT Number: NCT02596932

Intrapartum Glucose Management Among Women With Gestational Diabetes Mellitus

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

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

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Women & Infants Hospital Rhode Island

Providence, Rhode Island, 02905, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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

Other names: 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

Other names: Less Tight Control

Primary outcomes

  1. Mean neonatal blood glucose levels

    Time frame: 24 hours

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Women and Infants Hospital of Rhode Island

Other

Registry information

Official study title

Intrapartum Glucose Management Among Women With Gestational Diabetes Mellitus and Its Impact on Neonatal Blood Glucose Levels

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Nov 4, 2015
Registry last updated
Jan 7, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.