Intrapartum Glycemic Control in GDMA2

June 3, 2024 updated by: Inova Health Care Services

Management of Intrapartum Glycemia in Gestational Diabetic Mothers: A Randomized Controlled Trial

This is a randomized, parallel, controlled, non-inferiority trial to assess the impact of a tight versus a more liberalized intrapartum glycemic control in gestational diabetic mothers on neonatal glycemia. National guidelines for the management of intrapartum glucose in women with GDM are lacking. This is likely due to the scarcity of high-quality data on the topic.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

Gestational diabetes mellitus (GDM) remains a common pregnancy complication, affecting 6-15% of pregnancies worldwide. The incidence of GDM is expected to continue its global upward trend in light of the growing obesity epidemic and delayed childbearing. GDM is associated with adverse short- and long-term maternal and offspring outcomes. Neonatal hypoglycemia, as a result of fetal hyperinsulinemia, occurs in up to 35% of pregnancies complicated by GDM with potential long-term neurodevelopmental sequelae. In that regard, significant emphasis has been placed on the prevention of neonatal hypoglycemia through optimal maternal glycemic control. Available data are conflicting as to the contribution of intrapartum glycemia to neonatal glycemia.

Moreover, national guidelines for the management of intrapartum glucose in women with GDM are lacking. This is likely due to a lack of high-quality data on the topic. As far as we are aware, only one single center randomized controlled trial has been published on the topic. That study's findings suggest that an approach to a more liberalized intrapartum glycemic management was not associated with a higher rate of neonatal hypoglycemia compared to a tight glycemic control regimen. We propose to replicate these findings in a different population at our institution. If this more relaxed approach to intrapartum glycemic management is confirmed to be safe to women and their babies, its clinical application has the potential to decrease the inconvenience of frequent finger pricks for our patients during labor and allow more efficient allocation of resources for the nursing staff on an already labor-intensive unit.

Study Type

Interventional

Enrollment (Actual)

2

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Virginia
      • Falls Church, Virginia, United States, 22042
        • Inova Fairfax Medical Campus
      • Falls Church, Virginia, United States, 22042
        • Inova Health Care Services

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Women 18 years or older
  • Non-anomalous singleton gestation
  • Gestational diabetes type A2 diagnosed at 24 weeks' gestation or beyond
  • Planned vaginal delivery at term at Inova Fairfax Women's Hospital

Exclusion Criteria:

  • Women < 18 years
  • Fetus with major congenital malformations
  • Twin or higher order gestation
  • Pre-existing diabetes mellitus
  • Exposure to antenatal or any systemic steroids 14 days or less prior to delivery
  • Preterm delivery
  • Scheduled cesarean birth
  • Intrapartum cesarean birth prior to 4-5 cm of cervical dilatation

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Usual care glycemic management arm
Blood glucose will be checked every 2 hours during labor and glucose target will be 75-110 mg/dl
Other: Blood sugar check every 2 hours
Blood sugar check every 2 hours
Active Comparator: More liberalized glycemic management arm
Blood glucose will be checked every 4 hours during labor and glucose target will be 70-126 mg/dl
Other: Blood sugar check every 4 hours
Blood sugar check every 4 hours

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Initial neonatal glucose post delivery
Time Frame: first 2 hours of life
First blood sugar recorded in newborn after delivery
first 2 hours of life

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Neonatal hypoglycemia
Time Frame: Birth of newborn until discharge to home or up to 7 days, whichever occurs first
Blood glucose levels < 40 mg/dl in the first 4 hours of life or < 45 mg/dl beyond 4 hours of life
Birth of newborn until discharge to home or up to 7 days, whichever occurs first
Neonatal hypoglycemia requiring neonatal intensive care unit (NICU)
Time Frame: Birth of newborn until discharge to home or up to 7 days, whichever occurs first
Blood glucose levels < 40 mg/dl in the first 4 hours of life or < 45 mg/dl beyond 4 hours of life that necessitates admission to the neonatal intensive care unit
Birth of newborn until discharge to home or up to 7 days, whichever occurs first
Mean neonatal glucose within the first 24 hours post-delivery
Time Frame: First 24 hours after delivery
Average blood sugar in the newborn during the first 24 hours of life
First 24 hours after delivery
Neonatal intensive care unit admission
Time Frame: Birth of newborn until discharge to home or up to 7 days, whichever occurs first
Any admission to the Neonatal Intensive Care Unit (NICU) within the first 72 hours of delivery
Birth of newborn until discharge to home or up to 7 days, whichever occurs first
Neonatal intensive care unit length of stay
Time Frame: Birth of newborn until discharge to home or up to 7 days, whichever occurs first
Total time spent in the NICU from birth to discharge
Birth of newborn until discharge to home or up to 7 days, whichever occurs first
Neonatal jaundice requiring phototherapy
Time Frame: Birth of newborn until discharge to home or up to 7 days, whichever occurs first
As determined by the Pediatrics provider
Birth of newborn until discharge to home or up to 7 days, whichever occurs first
Mother's childbirth experience score
Time Frame: Intrapartum
Mother's experience of labor assessed by the Labor and Delivery Index (LADY-X) per Gartner et al.
Intrapartum

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of intrapartum glycemia checks
Time Frame: Intrapartum
Total number of blood sugar checks during labor
Intrapartum
Intrapartum glycemia mean
Time Frame: Intrapartum
Average maternal blood sugar during labor
Intrapartum
Intrapartum insulin use
Time Frame: Intrapartum
Use of insulin during labor
Intrapartum
Intrapartum insulin dose (total)
Time Frame: Intrapartum
Total insulin dose used during labor
Intrapartum

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Inova Health Care Services

Investigators

  • Principal Investigator: Jean W Thermolice, MD, Inova Healthcare Services

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 22, 2023

Primary Completion (Actual)

May 15, 2024

Study Completion (Actual)

May 15, 2024

Study Registration Dates

First Submitted

November 23, 2022

First Submitted That Met QC Criteria

December 3, 2022

First Posted (Actual)

December 13, 2022

Study Record Updates

Last Update Posted (Estimated)

June 4, 2024

Last Update Submitted That Met QC Criteria

June 3, 2024

Last Verified

June 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • U22-01-4642
  • Protocol #20222678 U22-01-4642 (Other Identifier: WCG IRB)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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