- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03273881
Intrapartum Glucose and Insulin Compared to Glucose Alone in Diabetic Women
Effect of Intrapartum Glucose With Compared to Without Constant Intravenous Insulin on Neonatal Hypoglycemia Among Diabetic Women. A Randomized Controlled Trial
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
About 2 to 9% of pregnant women are diagnosed with gestational diabetes. Peripartum complications attributed to diabetes include: birth trauma, neonatal hypoglycemia and hyperinsulinemia and neonatal hyperbilirubinemia. The incidence of neonatal hypoglycemia is about 40%. Strict glycemic control may lower the risk of neonatal complications. There is a lack of evidence on how to manage women with diabetes during labor. Previous studies recommended the use of intravenous saline solution boosted with 5% glucose and insulin as needed, glucose 5% with constant insulin infusion and others recommended the use lactated Ringer's solution. Most of these studies are either retrospective or have a small number of participants.
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).
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Gali Gali, MD
- Phone Number: 972-4-6494035
- Email: galit_ga@clalit.org.il
Study Contact Backup
- Name: Raed Salim, MD
- Phone Number: 972-4-6494355
- Email: salim_ra@clalit.org.il
Study Locations
-
-
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Afula, Israel, 18101
- Recruiting
- Haemek Medical Center
-
Contact:
- galit Garmi, MD
- Phone Number: 97246494335
- Email: galit_ga@clalit.org.il
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- >37 weeks gestation
- gestational diabetes mellitus according to Carpenter and Coustan
- pregestational diabetes mellitus
Exclusion Criteria:
- Intrauterine fetal death
- estimated fetal weight<10p
- multiple gestation
- major fetal malformations
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: 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.
|
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.
Other Names:
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 Names:
|
Active Comparator: glucose solution only
Participants will receive intravenous saline solution boosted with 5% glucose in a rate of 125 mL/h.
|
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.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Neonatal hypoglycemia
Time Frame: 2-3 hours postpartum
|
about 2-3 hours postpartum the neonate will have a capillary glucose test
|
2-3 hours postpartum
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Maternal glycemic control during labor
Time Frame: 24 hours
|
During labor glucose level will be obtained every hour.
Average glucose level during labor will be calculated after labor.
|
24 hours
|
Maternal urine ketones
Time Frame: 1 hour
|
Immediately post partum maternal urine will be checked for ketones
|
1 hour
|
Total amount of regular insulin during labor
Time Frame: 24 hours
|
The total amount of regular insulin during labor will be calculated post partum
|
24 hours
|
Mode of delivery
Time Frame: 1 hour
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Mode of delivery
|
1 hour
|
Length of delivery
Time Frame: 24 hours
|
Length of delivery
|
24 hours
|
Breastfeeding
Time Frame: 48 hours
|
How many women breastfed in every study group
|
48 hours
|
Neonatal APGAR score
Time Frame: 5 minutes
|
Neonatal APGAR score
|
5 minutes
|
Umbilical cord PH
Time Frame: 30 minutes
|
Umbilical cord PH
|
30 minutes
|
Umbilical cord glucose level
Time Frame: 30 minutes
|
Umbilical cord glucose level
|
30 minutes
|
The need for neonatal IV glucose infusion
Time Frame: 48 hours
|
The need for neonatal IV glucose infusion
|
48 hours
|
Neonatal jaundice
Time Frame: 48 hours
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Neonatal jaundice- hyperbilirubinemia
|
48 hours
|
Length of neonatal hospital stay
Time Frame: 30 days
|
Length of neonatal hospital stay
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30 days
|
NICU admission
Time Frame: 48 hours
|
NICU admission
|
48 hours
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Gali Gali, MD, HaEmemk Medical Center, Afula, Israel.
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 0056-17-EMC
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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