An interventional study of glucose solution and Insulin and glucose solution only in Obstetric Labor and Pregnancy in Diabetics, sponsored by HaEmek Medical Center, Israel. Recruiting at 1 site in Israel. Open to female participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-10-11.
Sponsored by HaEmek Medical Center, Israel · Not applicable, Interventional, and Prevention
This study aims to examine the effect of intrapartum treatment of diabetic women with combined glucose and constant insulin infusion compared to glucose alone on the incidence of neonatal hypoglycemia. Pregnant women with diabetes in pregnancy will be randomly divided during labor to 2 groups: group 1, will receive intravenous glucose with constant insulin infusion; group 2 will receive intravenous glucose alone. The primary outcome is the incidence of neonatal hypoglycemia.
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).
46 studies on the registry are indexed under Pregnancy in Diabetics; 16 are open to participants now.
This study's planned enrollment of 200 is above the median of 95 across 24 interventional studies indexed under Pregnancy in Diabetics.
Browse Pregnancy in Diabetics studies →HaEmek Medical Center, Israel is the lead sponsor of 237 studies on the registry; 11 are open to participants now.
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Exclusion Criteria:
Participants will receive intravenous saline solution boosted with 5% glucose + 8 units regular insulin in a rate of 125 mL/h.
Drug: glucose solution and Insulin · Drug: glucose solution only
Participants will receive intravenous saline solution boosted with 5% glucose in a rate of 125 mL/h.
Drug: 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.
Also known as: Group 1
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.
Also known as: Group 2
Neonatal hypoglycemia
about 2-3 hours postpartum the neonate will have a capillary glucose test
Time frame: 2-3 hours postpartum
Maternal glycemic control during labor
During labor glucose level will be obtained every hour. Average glucose level during labor will be calculated after labor.
Time frame: 24 hours
Maternal urine ketones
Immediately post partum maternal urine will be checked for ketones
Time frame: 1 hour
Total amount of regular insulin during labor
The total amount of regular insulin during labor will be calculated post partum
Time frame: 24 hours
Mode of delivery
Mode of delivery
Time frame: 1 hour
Length of delivery
Length of delivery
Time frame: 24 hours
Breastfeeding
How many women breastfed in every study group
Time frame: 48 hours
Neonatal APGAR score
Neonatal APGAR score
Time frame: 5 minutes
Umbilical cord PH
Umbilical cord PH
Time frame: 30 minutes
Umbilical cord glucose level
Umbilical cord glucose level
Time frame: 30 minutes
The need for neonatal IV glucose infusion
The need for neonatal IV glucose infusion
Time frame: 48 hours
Neonatal jaundice
Neonatal jaundice- hyperbilirubinemia
Time frame: 48 hours
Length of neonatal hospital stay
Length of neonatal hospital stay
Time frame: 30 days
NICU admission
NICU admission
Time frame: 48 hours
Plan to share: Undecided
Started Oct 2017 (actual). Primary completion is estimated for Dec 2023, 74 months after the start.
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HaEmek Medical Center, Israel →