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Intrapartum Glucose and Insulin Compared to Glucose Alone in Diabetic Women

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ClinicalTrials.gov Identifier: NCT03273881
Recruitment Status : Recruiting
First Posted : September 6, 2017
Last Update Posted : August 21, 2019
Sponsor:
Information provided by (Responsible Party):
Gali Garmy, HaEmek Medical Center, Israel

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Obstetric Labor Pregnancy in Diabetics Drug: glucose solution and Insulin Drug: glucose solution only Not Applicable

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).


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Effect of Intrapartum Glucose With Compared to Without Constant Intravenous Insulin on Neonatal Hypoglycemia Among Diabetic Women. A Randomized Controlled Trial
Actual Study Start Date : October 31, 2017
Estimated Primary Completion Date : February 2020
Estimated Study Completion Date : May 2020

Resource links provided by the National Library of Medicine


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.
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.

Other Name: Group 1

Drug: 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 Name: Group 2

Active Comparator: 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.

Other Name: Group 1




Primary Outcome Measures :
  1. Neonatal hypoglycemia [ Time Frame: 2-3 hours postpartum ]
    about 2-3 hours postpartum the neonate will have a capillary glucose test


Secondary Outcome Measures :
  1. 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.

  2. Maternal urine ketones [ Time Frame: 1 hour ]
    Immediately post partum maternal urine will be checked for ketones

  3. Total amount of regular insulin during labor [ Time Frame: 24 hours ]
    The total amount of regular insulin during labor will be calculated post partum

  4. Mode of delivery [ Time Frame: 1 hour ]
    Mode of delivery

  5. Length of delivery [ Time Frame: 24 hours ]
    Length of delivery

  6. Breastfeeding [ Time Frame: 48 hours ]
    How many women breastfed in every study group

  7. Neonatal APGAR score [ Time Frame: 5 minutes ]
    Neonatal APGAR score

  8. Umbilical cord PH [ Time Frame: 30 minutes ]
    Umbilical cord PH

  9. Umbilical cord glucose level [ Time Frame: 30 minutes ]
    Umbilical cord glucose level

  10. The need for neonatal IV glucose infusion [ Time Frame: 48 hours ]
    The need for neonatal IV glucose infusion

  11. Neonatal jaundice [ Time Frame: 48 hours ]
    Neonatal jaundice- hyperbilirubinemia

  12. Length of neonatal hospital stay [ Time Frame: 30 days ]
    Length of neonatal hospital stay

  13. NICU admission [ Time Frame: 48 hours ]
    NICU admission



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03273881


Contacts
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Contact: Gali Gali, MD 972-4-6494035 galit_ga@clalit.org.il
Contact: Raed Salim, MD 972-4-6494355 salim_ra@clalit.org.il

Locations
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Israel
HaEmek medical center Recruiting
Afula, Israel, 18101
Contact: galit Garmi, MD    97246494335    galit_ga@clalit.org.il   
Sponsors and Collaborators
HaEmek Medical Center, Israel
Investigators
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Principal Investigator: Gali Gali, MD HaEmemk Medical Center, Afula, Israel.

Publications of Results:
Other Publications:

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Responsible Party: Gali Garmy, Dr Gali Garmi, HaEmek Medical Center, Israel
ClinicalTrials.gov Identifier: NCT03273881     History of Changes
Other Study ID Numbers: 0056-17-EMC
First Posted: September 6, 2017    Key Record Dates
Last Update Posted: August 21, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Gali Garmy, HaEmek Medical Center, Israel:
Gestational diabetes mellitus
Pre-gestational diabetes mellitus
Treatment
Neonatal hypoglycemia
Additional relevant MeSH terms:
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Pregnancy in Diabetics
Pregnancy Complications
Insulin
Insulin, Globin Zinc
Pharmaceutical Solutions
Hypoglycemic Agents
Physiological Effects of Drugs