Intrapartum Glycemic Control in GDMA2

NCT05647798 | Terminated

• 2 other identifiers: U22-01-4642Protocol #20222678 U22-01-4642
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 2

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.

Conditions

Pregnancy; Gestational Diabetes Mellitus, Class A2; Neonatal Hypoglycemia

Keywords

Intrapartum Glycemia; Labor

Outcome Measures

Primary Outcomes (1)

• Initial neonatal glucose post delivery

  First blood sugar recorded in newborn after delivery

  first 2 hours of life

Secondary Outcomes (7)

• Neonatal hypoglycemia

  Birth of newborn until discharge to home or up to 7 days, whichever occurs first

• Neonatal hypoglycemia requiring neonatal intensive care unit (NICU)

  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

  First 24 hours after delivery

• Neonatal intensive care unit admission

  Birth of newborn until discharge to home or up to 7 days, whichever occurs first

• Neonatal intensive care unit length of stay

  Birth of newborn until discharge to home or up to 7 days, whichever occurs first

Other Outcomes (4)

• Number of intrapartum glycemia checks

  Intrapartum

• Intrapartum glycemia mean

  Intrapartum

• Intrapartum insulin use

  Intrapartum

Study Arms (2)

Usual care glycemic management arm

ACTIVE COMPARATOR

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

More liberalized glycemic management arm

ACTIVE COMPARATOR

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

Interventions

Blood sugar check every 2 hours OTHER

Blood sugar check every 2 hours

Usual care glycemic management arm

Blood sugar check every 4 hours OTHER

Blood sugar check every 4 hours

More liberalized glycemic management arm

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Inova Health Care Services: lead

Study Sites (2)

Inova Fairfax Medical campus

Falls Church, Virginia, 22042, United States

Location

Inova Health Care Services

Falls Church, Virginia, 22042, United States

Location

Related Publications (15)

• 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.

  PMID: 31296866 BACKGROUND

• 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.

  PMID: 29040334 BACKGROUND

• 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.

  PMID: 29517506 BACKGROUND

• 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.

  PMID: 27510598 BACKGROUND

• Martin JA, Hamilton BE, Osterman MJK, Driscoll AK. Births: Final Data for 2018. Natl Vital Stat Rep. 2019 Nov;68(13):1-47.

  PMID: 32501202 BACKGROUND

• ACOG Practice Bulletin No. 190: Gestational Diabetes Mellitus. Obstet Gynecol. 2018 Feb;131(2):e49-e64. doi: 10.1097/AOG.0000000000002501.

  PMID: 29370047 BACKGROUND

• 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.

  PMID: 32946125 BACKGROUND

• 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.

  PMID: 29654142 BACKGROUND

• 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.

  PMID: 11924935 BACKGROUND

• 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.

  PMID: 22306045 BACKGROUND

• 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.

  PMID: 26613985 BACKGROUND

• 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.

  PMID: 30408811 BACKGROUND

• 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.

  PMID: 29117445 BACKGROUND

• 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.

  PMID: 31529717 BACKGROUND

• 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 BACKGROUND

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

• Jean W Thermolice, MD

  Inova Healthcare Services

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 23, 2022
• First Posted: December 13, 2022
• Study Start: May 22, 2023
• Primary Completion: May 15, 2024
• Study Completion: May 15, 2024
• Last Updated: June 4, 2024

Record last verified: 2024-06

Locations

US (2)