Intrapartum Glycemic Control in GDMA2

Sponsor

Inova Health Care Services (Other)

Overall Status

Recruiting

CT.gov ID

NCT05647798

Collaborator

(none)

120

Enrollment

Locations

Arms

Anticipated Duration (Months)

Patients Per Site

5.5

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Pregnancy Gestational Diabetes Mellitus, Class A2 Neonatal Hypoglycemia	Other: Blood sugar check every 2 hours Other: Blood sugar check every 4 hours	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

120 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Other

Official Title:

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

Anticipated Study Start Date :

Jan 1, 2023

Anticipated Primary Completion Date :

Dec 1, 2023

Anticipated Study Completion Date :

Dec 1, 2023

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Initial neonatal glucose post delivery [first 2 hours of life]
First blood sugar recorded in newborn after delivery

Secondary Outcome Measures

Neonatal hypoglycemia [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
Neonatal hypoglycemia requiring neonatal intensive care unit (NICU) [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
Mean neonatal glucose within the first 24 hours post-delivery [First 24 hours after delivery]
Average blood sugar in the newborn during the first 24 hours of life
Neonatal intensive care unit admission [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
Neonatal intensive care unit length of stay [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
Neonatal jaundice requiring phototherapy [Birth of newborn until discharge to home or up to 7 days, whichever occurs first]
As determined by the Pediatrics provider
Mother's childbirth experience score [Intrapartum]
Mother's experience of labor assessed by the Labor and Delivery Index (LADY-X) per Gartner et al.

Other Outcome Measures

Number of intrapartum glycemia checks [Intrapartum]
Total number of blood sugar checks during labor
Intrapartum glycemia mean [Intrapartum]
Average maternal blood sugar during labor
Intrapartum insulin use [Intrapartum]
Use of insulin during labor
Intrapartum insulin dose (total) [Intrapartum]
Total insulin dose used during labor

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Inova Fairfax Medical campus	Falls Church	Virginia	United States	22042
2	Inova Health Care Services	Falls Church	Virginia	United States	22042

Sponsors and Collaborators

Inova Health Care Services

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:

Jean W Thermolice, Medical Doctor, Inova Health Care Services

ClinicalTrials.gov Identifier:

NCT05647798

Other Study ID Numbers:

U022-01-4642
Protocol #20222678 U22-01-4642

First Posted:

Dec 13, 2022

Last Update Posted:

Jan 27, 2023

Last Verified:

Jan 1, 2023

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Jean W Thermolice, Medical Doctor, Inova Health Care Services

Intrapartum Glycemia

Labor

Additional relevant MeSH terms:

Diabetes, Gestational

Hypoglycemia

Study Results

No Results Posted as of Jan 27, 2023