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| ID | Type | Description | Link |
|---|---|---|---|
| Protocol #20222678 U22-01-4642 | Other Identifier | WCG IRB |
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Poor recruitment
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Blood sugar check every 2 hours | Other | Blood sugar check every 2 hours |
|
| Measure | Description | Time Frame |
|---|---|---|
| Initial neonatal glucose post delivery | First blood sugar recorded in newborn after delivery | first 2 hours of life |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Neonatal hypoglycemia requiring neonatal intensive care unit (NICU) |
| Measure | Description | Time Frame |
|---|---|---|
| Number of intrapartum glycemia checks | Total number of blood sugar checks during labor | Intrapartum |
| Intrapartum glycemia mean | Average maternal blood sugar during labor |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jean W Thermolice, MD | Inova Healthcare Services | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Inova Fairfax Medical campus | Falls Church | Virginia | 22042 | United States | ||
| Inova Health Care Services |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31296866 | Background | 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. | |
| 29040334 | 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. |
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| ID | Term |
|---|---|
| D016640 | Diabetes, Gestational |
| ID | Term |
|---|---|
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D003920 | Diabetes Mellitus |
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| Blood sugar check every 4 hours | Other | Blood sugar check every 4 hours |
|
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 |
| 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 |
| 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 |
| 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 |
| 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 |
| Mother's childbirth experience score | Mother's experience of labor assessed by the Labor and Delivery Index (LADY-X) per Gartner et al. | Intrapartum |
| Intrapartum |
| Intrapartum insulin use | Use of insulin during labor | Intrapartum |
| Intrapartum insulin dose (total) | Total insulin dose used during labor | Intrapartum |
| Falls Church |
| Virginia |
| 22042 |
| United States |
| 29517506 | 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. |
| 27510598 | 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. |
| 32501202 | Background | Martin JA, Hamilton BE, Osterman MJK, Driscoll AK. Births: Final Data for 2018. Natl Vital Stat Rep. 2019 Nov;68(13):1-47. |
| 29370047 | Background | ACOG Practice Bulletin No. 190: Gestational Diabetes Mellitus. Obstet Gynecol. 2018 Feb;131(2):e49-e64. doi: 10.1097/AOG.0000000000002501. |
| 32946125 | 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. |
| 29654142 | 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. |
| 11924935 | 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. |
| 22306045 | 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. |
| 26613985 | 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. |
| 30408811 | 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. |
| 29117445 | 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. |
| 31529717 | 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. |
| 31135731 | 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. |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |