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Intrapartum Glycemic Control in GDMA2

Primary Purpose

Pregnancy, Gestational Diabetes Mellitus, Class A2, Neonatal Hypoglycemia

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Blood sugar check every 2 hours
Blood sugar check every 4 hours
Sponsored by
Inova Health Care Services
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Pregnancy focused on measuring Intrapartum Glycemia, Labor

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • Inova Fairfax Medical campusRecruiting
  • Inova Health Care Services

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Usual care glycemic management arm

More liberalized glycemic management arm

Arm Description

Blood glucose will be checked every 2 hours during labor and glucose target will be 75-110 mg/dl

Blood glucose will be checked every 4 hours during labor and glucose target will be 70-126 mg/dl

Outcomes

Primary Outcome Measures

Initial neonatal glucose post delivery
First blood sugar recorded in newborn after delivery

Secondary Outcome Measures

Neonatal hypoglycemia
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)
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
Average blood sugar in the newborn during the first 24 hours of life
Neonatal intensive care unit admission
Any admission to the Neonatal Intensive Care Unit (NICU) within the first 72 hours of delivery
Neonatal intensive care unit length of stay
Total time spent in the NICU from birth to discharge
Neonatal jaundice requiring phototherapy
As determined by the Pediatrics provider
Mother's childbirth experience score
Mother's experience of labor assessed by the Labor and Delivery Index (LADY-X) per Gartner et al.

Full Information

First Posted
November 23, 2022
Last Updated
May 25, 2023
Sponsor
Inova Health Care Services
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1. Study Identification

Unique Protocol Identification Number
NCT05647798
Brief Title
Intrapartum Glycemic Control in GDMA2
Official Title
Management of Intrapartum Glycemia in Gestational Diabetic Mothers: A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 22, 2023 (Actual)
Primary Completion Date
December 2024 (Anticipated)
Study Completion Date
December 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Inova Health Care Services

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pregnancy, Gestational Diabetes Mellitus, Class A2, Neonatal Hypoglycemia
Keywords
Intrapartum Glycemia, Labor

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Usual care glycemic management arm
Arm Type
Active Comparator
Arm Description
Blood glucose will be checked every 2 hours during labor and glucose target will be 75-110 mg/dl
Arm Title
More liberalized glycemic management arm
Arm Type
Active Comparator
Arm Description
Blood glucose will be checked every 4 hours during labor and glucose target will be 70-126 mg/dl
Intervention Type
Other
Intervention Name(s)
Blood sugar check every 2 hours
Intervention Description
Blood sugar check every 2 hours
Intervention Type
Other
Intervention Name(s)
Blood sugar check every 4 hours
Intervention Description
Blood sugar check every 4 hours
Primary Outcome Measure Information:
Title
Initial neonatal glucose post delivery
Description
First blood sugar recorded in newborn after delivery
Time Frame
first 2 hours of life
Secondary Outcome Measure Information:
Title
Neonatal hypoglycemia
Description
Blood glucose levels < 40 mg/dl in the first 4 hours of life or < 45 mg/dl beyond 4 hours of life
Time Frame
Birth of newborn until discharge to home or up to 7 days, whichever occurs first
Title
Neonatal hypoglycemia requiring neonatal intensive care unit (NICU)
Description
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
Time Frame
Birth of newborn until discharge to home or up to 7 days, whichever occurs first
Title
Mean neonatal glucose within the first 24 hours post-delivery
Description
Average blood sugar in the newborn during the first 24 hours of life
Time Frame
First 24 hours after delivery
Title
Neonatal intensive care unit admission
Description
Any admission to the Neonatal Intensive Care Unit (NICU) within the first 72 hours of delivery
Time Frame
Birth of newborn until discharge to home or up to 7 days, whichever occurs first
Title
Neonatal intensive care unit length of stay
Description
Total time spent in the NICU from birth to discharge
Time Frame
Birth of newborn until discharge to home or up to 7 days, whichever occurs first
Title
Neonatal jaundice requiring phototherapy
Description
As determined by the Pediatrics provider
Time Frame
Birth of newborn until discharge to home or up to 7 days, whichever occurs first
Title
Mother's childbirth experience score
Description
Mother's experience of labor assessed by the Labor and Delivery Index (LADY-X) per Gartner et al.
Time Frame
Intrapartum
Other Pre-specified Outcome Measures:
Title
Number of intrapartum glycemia checks
Description
Total number of blood sugar checks during labor
Time Frame
Intrapartum
Title
Intrapartum glycemia mean
Description
Average maternal blood sugar during labor
Time Frame
Intrapartum
Title
Intrapartum insulin use
Description
Use of insulin during labor
Time Frame
Intrapartum
Title
Intrapartum insulin dose (total)
Description
Total insulin dose used during labor
Time Frame
Intrapartum

10. Eligibility

Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jean W Thermolice, MD
Phone
703-531-3000
Email
jean.thermolice@inova.org
First Name & Middle Initial & Last Name or Official Title & Degree
Helen Shi, MD
Email
helen.shi@inova.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jean W Thermolice, MD
Organizational Affiliation
Inova Healthcare Services
Official's Role
Principal Investigator
Facility Information:
Facility Name
Inova Fairfax Medical campus
City
Falls Church
State/Province
Virginia
ZIP/Postal Code
22042
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jean W Thermolice, MD
Phone
703-531-3000
Email
jean.thermolice@inova.org
Facility Name
Inova Health Care Services
City
Falls Church
State/Province
Virginia
ZIP/Postal Code
22042
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jean W Thermolice, MD
First Name & Middle Initial & Last Name & Degree
Helen Shi, MD
First Name & Middle Initial & Last Name & Degree
Raven Eberth, BS

12. IPD Sharing Statement

Citations:
PubMed Identifier
31296866
Citation
McIntyre HD, Catalano P, Zhang C, Desoye G, Mathiesen ER, Damm P. Gestational diabetes mellitus. Nat Rev Dis Primers. 2019 Jul 11;5(1):47. doi: 10.1038/s41572-019-0098-8.
Results Reference
background
PubMed Identifier
29040334
Citation
Lean SC, Derricott H, Jones RL, Heazell AEP. Advanced maternal age and adverse pregnancy outcomes: A systematic review and meta-analysis. PLoS One. 2017 Oct 17;12(10):e0186287. doi: 10.1371/journal.pone.0186287. eCollection 2017.
Results Reference
background
PubMed Identifier
29517506
Citation
Schummers L, Hutcheon JA, Hacker MR, VanderWeele TJ, Williams PL, McElrath TF, Hernandez-Diaz S. Absolute risks of obstetric outcomes by maternal age at first birth: a population-based cohort. Epidemiology. 2018 May;29(3):379-387. doi: 10.1097/EDE.0000000000000818. Erratum In: Epidemiology. 2018 Jul;29(4):e38.
Results Reference
background
PubMed Identifier
27510598
Citation
Lavery JA, Friedman AM, Keyes KM, Wright JD, Ananth CV. Gestational diabetes in the United States: temporal changes in prevalence rates between 1979 and 2010. BJOG. 2017 Apr;124(5):804-813. doi: 10.1111/1471-0528.14236. Epub 2016 Aug 11.
Results Reference
background
PubMed Identifier
32501202
Citation
Martin JA, Hamilton BE, Osterman MJK, Driscoll AK. Births: Final Data for 2018. Natl Vital Stat Rep. 2019 Nov;68(13):1-47.
Results Reference
background
PubMed Identifier
29370047
Citation
ACOG Practice Bulletin No. 190: Gestational Diabetes Mellitus. Obstet Gynecol. 2018 Feb;131(2):e49-e64. doi: 10.1097/AOG.0000000000002501.
Results Reference
background
PubMed Identifier
32946125
Citation
Murray SR, Reynolds RM. Short- and long-term outcomes of gestational diabetes and its treatment on fetal development. Prenat Diagn. 2020 Aug;40(9):1085-1091. doi: 10.1002/pd.5768. Epub 2020 Jul 1.
Results Reference
background
PubMed Identifier
29654142
Citation
Voormolen DN, de Wit L, van Rijn BB, DeVries JH, Heringa MP, Franx A, Groenendaal F, Lamain-de Ruiter M. Neonatal Hypoglycemia Following Diet-Controlled and Insulin-Treated Gestational Diabetes Mellitus. Diabetes Care. 2018 Jul;41(7):1385-1390. doi: 10.2337/dc18-0048. Epub 2018 Apr 13.
Results Reference
background
PubMed Identifier
11924935
Citation
Dalgic N, Ergenekon E, Soysal S, Koc E, Atalay Y, Gucuyener K. Transient neonatal hypoglycemia--long-term effects on neurodevelopmental outcome. J Pediatr Endocrinol Metab. 2002 Mar;15(3):319-24. doi: 10.1515/jpem.2002.15.3.319.
Results Reference
background
PubMed Identifier
22306045
Citation
Tam EW, Haeusslein LA, Bonifacio SL, Glass HC, Rogers EE, Jeremy RJ, Barkovich AJ, Ferriero DM. Hypoglycemia is associated with increased risk for brain injury and adverse neurodevelopmental outcome in neonates at risk for encephalopathy. J Pediatr. 2012 Jul;161(1):88-93. doi: 10.1016/j.jpeds.2011.12.047. Epub 2012 Feb 4.
Results Reference
background
PubMed Identifier
26613985
Citation
Harris DL, Alsweiler JM, Ansell JM, Gamble GD, Thompson B, Wouldes TA, Yu TY, Harding JE; Children with Hypoglycaemia and their Later Development (CHYLD) Study Team. Outcome at 2 Years after Dextrose Gel Treatment for Neonatal Hypoglycemia: Follow-Up of a Randomized Trial. J Pediatr. 2016 Mar;170:54-9.e1-2. doi: 10.1016/j.jpeds.2015.10.066. Epub 2015 Nov 21.
Results Reference
background
PubMed Identifier
30408811
Citation
Shah R, Harding J, Brown J, McKinlay C. Neonatal Glycaemia and Neurodevelopmental Outcomes: A Systematic Review and Meta-Analysis. Neonatology. 2019;115(2):116-126. doi: 10.1159/000492859. Epub 2018 Nov 8.
Results Reference
background
PubMed Identifier
29117445
Citation
Yamamoto JM, Benham J, Mohammad K, Donovan LE, Wood S. Intrapartum glycaemic control and neonatal hypoglycaemia in pregnancies complicated by diabetes: a systematic review. Diabet Med. 2018 Feb;35(2):173-183. doi: 10.1111/dme.13546.
Results Reference
background
PubMed Identifier
31529717
Citation
Yamamoto JM, Donovan LE, Mohammad K, Wood SL. Severe neonatal hypoglycaemia and intrapartum glycaemic control in pregnancies complicated by type 1, type 2 and gestational diabetes. Diabet Med. 2020 Jan;37(1):138-146. doi: 10.1111/dme.14137. Epub 2019 Oct 11.
Results Reference
background
PubMed Identifier
31135731
Citation
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.
Results Reference
background

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Intrapartum Glycemic Control in GDMA2

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