Intrapartum Glucose and Insulin Compared to Glucose Alone in Diabetic Women
NCT ID: NCT03273881
Last Updated: 2023-10-11
Study Results
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Basic Information
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UNKNOWN
NA
200 participants
INTERVENTIONAL
2017-10-31
2023-12-31
Brief Summary
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Detailed Description
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In this study we will examine the effect of 2 different protocols on glycemic control during labor and the immediate neonatal period. Women in group 1, will receive intravenous saline solution boosted with 5% glucose and constant insulin infusion. Women in group 2, will receive intravenous saline solution boosted with 5% glucose alone. The desirable intrapartum glucose level will be 70 to 100 mg/dL. Glucose levels will be checked hourly. Women in both groups will receive additional insulin infusion in cases of glucose levels above 100 mg/dL. Additionally, the 5% glucose solution will be substitute with lactated Ringer's solution in cases of glucose levels above 140 mg/dL.
Intravenous fluid regimens will be assigned according to a computer randomization sequence generation program. Women will randomly assigned to the 2 groups in a 1:1 ratio. The randomization sequence results will be kept in the delivery ward in a closed study box. Site investigators will enroll participants after confirming eligibility. The sequence will be concealed until intervention is assigned (and after obtaining a signed informed consent).
Our hypothesis is that 5% glucose combined with constant insulin infusion will achieve better glycemic control and thus will lead to lower rate of neonatal hypoglycemia. In order to detect a reduction of neonatal hypoglycemia from 40% to 20%, 182 women will be needed in both groups in order to achieve a level of significance of 95% (α, 2-sided = 0.05) and a power of 80% (β = 0.2).
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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glucose solution and insulin
Participants will receive intravenous saline solution boosted with 5% glucose + 8 units regular insulin in a rate of 125 mL/h.
glucose solution and Insulin
Women in group 1, will receive intravenous saline solution boosted with 5% glucose combined with 8 units of insulin at a rate of 125mL/h. The desirable intrapartum glucose level will be 70 to 100 mg/dL. Glucose levels will be checked hourly.
Glucose level between 100-140 mg/dL will be treated with additional intravenous insulin, 1 units/hour.
Glucose level between 141-160 mg/dL will be treated with intravenous insulin, 2 units/hour. Additionally, the 5% glucose solution will be substitute with lactated Ringer's solution.
Glucose level between 161-200 mg/dL will be treated with intravenous insulin, 4 units/hour.
Glucose level above 200 mg/dL will be treated with intravenous insulin, 6 units/hour.
glucose solution only
Women in group 2, will receive intravenous saline solution boosted with 5% glucose only, at a rate of 125mL/h. Women in this group will be treated similar to group 1 if glucose levels crossed over 100 mg/dL.
glucose solution only
Participants will receive intravenous saline solution boosted with 5% glucose in a rate of 125 mL/h.
glucose solution and Insulin
Women in group 1, will receive intravenous saline solution boosted with 5% glucose combined with 8 units of insulin at a rate of 125mL/h. The desirable intrapartum glucose level will be 70 to 100 mg/dL. Glucose levels will be checked hourly.
Glucose level between 100-140 mg/dL will be treated with additional intravenous insulin, 1 units/hour.
Glucose level between 141-160 mg/dL will be treated with intravenous insulin, 2 units/hour. Additionally, the 5% glucose solution will be substitute with lactated Ringer's solution.
Glucose level between 161-200 mg/dL will be treated with intravenous insulin, 4 units/hour.
Glucose level above 200 mg/dL will be treated with intravenous insulin, 6 units/hour.
Interventions
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glucose solution and Insulin
Women in group 1, will receive intravenous saline solution boosted with 5% glucose combined with 8 units of insulin at a rate of 125mL/h. The desirable intrapartum glucose level will be 70 to 100 mg/dL. Glucose levels will be checked hourly.
Glucose level between 100-140 mg/dL will be treated with additional intravenous insulin, 1 units/hour.
Glucose level between 141-160 mg/dL will be treated with intravenous insulin, 2 units/hour. Additionally, the 5% glucose solution will be substitute with lactated Ringer's solution.
Glucose level between 161-200 mg/dL will be treated with intravenous insulin, 4 units/hour.
Glucose level above 200 mg/dL will be treated with intravenous insulin, 6 units/hour.
glucose solution only
Women in group 2, will receive intravenous saline solution boosted with 5% glucose only, at a rate of 125mL/h. Women in this group will be treated similar to group 1 if glucose levels crossed over 100 mg/dL.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* gestational diabetes mellitus according to Carpenter and Coustan
* pregestational diabetes mellitus
Exclusion Criteria
* estimated fetal weight\<10p
* multiple gestation
* major fetal malformations
18 Years
60 Years
FEMALE
Yes
Sponsors
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Holy Family Hospital, Nazareth, Israel
OTHER
HaEmek Medical Center, Israel
OTHER
Responsible Party
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Gali Garmy
Dr Gali Garmi
Principal Investigators
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Gali Gali, MD
Role: PRINCIPAL_INVESTIGATOR
HaEmemk Medical Center, Afula, Israel.
Locations
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HaEmek medical center
Afula, , Israel
Countries
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Central Contacts
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Facility Contacts
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References
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Soler NG, Soler SM, Malins JM. Neonatal morbidity among infants of diabetic mothers. Diabetes Care. 1978 Nov-Dec;1(6):340-50. doi: 10.2337/diacare.1.6.340.
Sacks DA, Hadden DR, Maresh M, Deerochanawong C, Dyer AR, Metzger BE, Lowe LP, Coustan DR, Hod M, Oats JJ, Persson B, Trimble ER; HAPO Study Cooperative Research Group. Frequency of gestational diabetes mellitus at collaborating centers based on IADPSG consensus panel-recommended criteria: the Hyperglycemia and Adverse Pregnancy Outcome (HAPO) Study. Diabetes Care. 2012 Mar;35(3):526-8. doi: 10.2337/dc11-1641.
Taricco E, Radaelli T, Rossi G, Nobile de Santis MS, Bulfamante GP, Avagliano L, Cetin I. Effects of gestational diabetes on fetal oxygen and glucose levels in vivo. BJOG. 2009 Dec;116(13):1729-35. doi: 10.1111/j.1471-0528.2009.02341.x. Epub 2009 Oct 13.
HAPO Study Cooperative Research Group; Metzger BE, Lowe LP, Dyer AR, Trimble ER, Chaovarindr U, Coustan DR, Hadden DR, McCance DR, Hod M, McIntyre HD, Oats JJ, Persson B, Rogers MS, Sacks DA. Hyperglycemia and adverse pregnancy outcomes. N Engl J Med. 2008 May 8;358(19):1991-2002. doi: 10.1056/NEJMoa0707943.
Reece EA, Leguizamon G, Wiznitzer A. Gestational diabetes: the need for a common ground. Lancet. 2009 May 23;373(9677):1789-97. doi: 10.1016/S0140-6736(09)60515-8.
Ju H, Rumbold AR, Willson KJ, Crowther CA. Borderline gestational diabetes mellitus and pregnancy outcomes. BMC Pregnancy Childbirth. 2008 Jul 30;8:31. doi: 10.1186/1471-2393-8-31.
Catalano PM, McIntyre HD, Cruickshank JK, McCance DR, Dyer AR, Metzger BE, Lowe LP, Trimble ER, Coustan DR, Hadden DR, Persson B, Hod M, Oats JJ; HAPO Study Cooperative Research Group. The hyperglycemia and adverse pregnancy outcome study: associations of GDM and obesity with pregnancy outcomes. Diabetes Care. 2012 Apr;35(4):780-6. doi: 10.2337/dc11-1790. Epub 2012 Feb 22.
Committee on Fetus and Newborn; Adamkin DH. Postnatal glucose homeostasis in late-preterm and term infants. Pediatrics. 2011 Mar;127(3):575-9. doi: 10.1542/peds.2010-3851. Epub 2011 Feb 28.
Carron Brown S, Kyne-Grzebalski D, Mwangi B, Taylor R. Effect of management policy upon 120 Type 1 diabetic pregnancies: policy decisions in practice. Diabet Med. 1999 Jul;16(7):573-8. doi: 10.1046/j.1464-5491.1999.00124.x.
Kline GA, Edwards A. Antepartum and intra-partum insulin management of type 1 and type 2 diabetic women: Impact on clinically significant neonatal hypoglycemia. Diabetes Res Clin Pract. 2007 Aug;77(2):223-30. doi: 10.1016/j.diabres.2006.10.024. Epub 2006 Nov 28.
Lean ME, Pearson DW, Sutherland HW. Insulin management during labour and delivery in mothers with diabetes. Diabet Med. 1990 Feb;7(2):162-4. doi: 10.1111/j.1464-5491.1990.tb01352.x.
Balsells M, Corcoy R, Adelantado JM, Garcia-Patterson A, Altirriba O, de Leiva A. Gestational diabetes mellitus: metabolic control during labour. Diabetes Nutr Metab. 2000 Oct;13(5):257-62.
Hussain K, Sharief N. The inaccuracy of venous and capillary blood glucose measurement using reagent strips in the newborn period and the effect of haematocrit. Early Hum Dev. 2000 Feb;57(2):111-21. doi: 10.1016/s0378-3782(99)00060-2.
Hernandez-Rivas E, Flores-Le Roux JA, Benaiges D, Sagarra E, Chillaron JJ, Paya A, Puig-de Dou J, Goday A, Lopez-Vilchez MA, Pedro-Botet J. Gestational diabetes in a multiethnic population of Spain: clinical characteristics and perinatal outcomes. Diabetes Res Clin Pract. 2013 May;100(2):215-21. doi: 10.1016/j.diabres.2013.01.030. Epub 2013 Mar 26.
Carpenter MW, Coustan DR. Criteria for screening tests for gestational diabetes. Am J Obstet Gynecol. 1982 Dec 1;144(7):768-73. doi: 10.1016/0002-9378(82)90349-0.
Other Identifiers
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0056-17-EMC
Identifier Type: -
Identifier Source: org_study_id
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