Pregnancy Clinical Trial
Official title:
Management of Intrapartum Glycemia in Gestational Diabetic Mothers: A Randomized Controlled Trial
Verified date | June 2024 |
Source | Inova Health Care Services |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
Country | Name | City | State |
---|---|---|---|
United States | Inova Fairfax Medical campus | Falls Church | Virginia |
United States | Inova Health Care Services | Falls Church | Virginia |
Lead Sponsor | Collaborator |
---|---|
Inova Health Care Services |
United States,
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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
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* Note: There are 15 references in all — Click here to view all references
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 |
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