Intrapartum Glycemic Control in GDMA2

Pregnancy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT05647798
• Other study ID #: U22-01-4642
• Secondary ID: Protocol #202226
• Status: Terminated
• Phase: N/A
• Start date: May 22, 2023
• Est. completion date: May 15, 2024

Study information

• Verified date: June 2024
• Source: Inova Health Care Services
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 2
• Est. completion date: May 15, 2024
• Est. primary completion date: May 15, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes, Gestational
• Gestational Diabetes Mellitus, Class A2
• Hypoglycemia
• Neonatal Hypoglycemia
• Pregnancy

Intervention

Other:
• Blood sugar check every 2 hours
Blood sugar check every 2 hours
• Blood sugar check every 4 hours
Blood sugar check every 4 hours

Locations

Country	Name	City	State
United States	Inova Fairfax Medical campus	Falls Church	Virginia
United States	Inova Health Care Services	Falls Church	Virginia

Sponsors (1)

Lead Sponsor	Collaborator
Inova Health Care Services

Country where clinical trial is conducted

United States, 

References & Publications (15)

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

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

* Note: There are 15 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Number of intrapartum glycemia checks	Total number of blood sugar checks during labor	Intrapartum
Other	Intrapartum glycemia mean	Average maternal blood sugar during labor	Intrapartum
Other	Intrapartum insulin use	Use of insulin during labor	Intrapartum
Other	Intrapartum insulin dose (total)	Total insulin dose used during labor	Intrapartum
Primary	Initial neonatal glucose post delivery	First blood sugar recorded in newborn after delivery	first 2 hours of life
Secondary	Neonatal hypoglycemia	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
Secondary	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	Birth of newborn until discharge to home or up to 7 days, whichever occurs first
Secondary	Mean neonatal glucose within the first 24 hours post-delivery	Average blood sugar in the newborn during the first 24 hours of life	First 24 hours after delivery
Secondary	Neonatal intensive care unit admission	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
Secondary	Neonatal intensive care unit length of stay	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
Secondary	Neonatal jaundice requiring phototherapy	As determined by the Pediatrics provider	Birth of newborn until discharge to home or up to 7 days, whichever occurs first
Secondary	Mother's childbirth experience score	Mother's experience of labor assessed by the Labor and Delivery Index (LADY-X) per Gartner et al.	Intrapartum