<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03273881</url>
  </required_header>
  <id_info>
    <org_study_id>0056-17-EMC</org_study_id>
    <nct_id>NCT03273881</nct_id>
  </id_info>
  <brief_title>Intrapartum Glucose and Insulin Compared to Glucose Alone in Diabetic Women</brief_title>
  <official_title>Effect of Intrapartum Glucose With Compared to Without Constant Intravenous Insulin on Neonatal Hypoglycemia Among Diabetic Women. A Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>HaEmek Medical Center, Israel</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>HaEmek Medical Center, Israel</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study aims to examine the effect of intrapartum treatment of diabetic women with&#xD;
      combined glucose and constant insulin infusion compared to glucose alone on the incidence of&#xD;
      neonatal hypoglycemia. Pregnant women with diabetes in pregnancy will be randomly divided&#xD;
      during labor to 2 groups: group 1, will receive intravenous glucose with constant insulin&#xD;
      infusion; group 2 will receive intravenous glucose alone. The primary outcome is the&#xD;
      incidence of neonatal hypoglycemia.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      About 2 to 9% of pregnant women are diagnosed with gestational diabetes. Peripartum&#xD;
      complications attributed to diabetes include: birth trauma, neonatal hypoglycemia and&#xD;
      hyperinsulinemia and neonatal hyperbilirubinemia. The incidence of neonatal hypoglycemia is&#xD;
      about 40%. Strict glycemic control may lower the risk of neonatal complications. There is a&#xD;
      lack of evidence on how to manage women with diabetes during labor. Previous studies&#xD;
      recommended the use of intravenous saline solution boosted with 5% glucose and insulin as&#xD;
      needed, glucose 5% with constant insulin infusion and others recommended the use lactated&#xD;
      Ringer's solution. Most of these studies are either retrospective or have a small number of&#xD;
      participants.&#xD;
&#xD;
      In this study we will examine the effect of 2 different protocols on glycemic control during&#xD;
      labor and the immediate neonatal period. Women in group 1, will receive intravenous saline&#xD;
      solution boosted with 5% glucose and constant insulin infusion. Women in group 2, will&#xD;
      receive intravenous saline solution boosted with 5% glucose alone. The desirable intrapartum&#xD;
      glucose level will be 70 to 100 mg/dL. Glucose levels will be checked hourly. Women in both&#xD;
      groups will receive additional insulin infusion in cases of glucose levels above 100 mg/dL.&#xD;
      Additionally, the 5% glucose solution will be substitute with lactated Ringer's solution in&#xD;
      cases of glucose levels above 140 mg/dL.&#xD;
&#xD;
      Intravenous fluid regimens will be assigned according to a computer randomization sequence&#xD;
      generation program. Women will randomly assigned to the 2 groups in a 1:1 ratio. The&#xD;
      randomization sequence results will be kept in the delivery ward in a closed study box. Site&#xD;
      investigators will enroll participants after confirming eligibility. The sequence will be&#xD;
      concealed until intervention is assigned (and after obtaining a signed informed consent).&#xD;
&#xD;
      Our hypothesis is that 5% glucose combined with constant insulin infusion will achieve better&#xD;
      glycemic control and thus will lead to lower rate of neonatal hypoglycemia. In order to&#xD;
      detect a reduction of neonatal hypoglycemia from 40% to 20%, 182 women will be needed in both&#xD;
      groups in order to achieve a level of significance of 95% (α, 2-sided = 0.05) and a power of&#xD;
      80% (β = 0.2).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">October 31, 2017</start_date>
  <completion_date type="Anticipated">December 2022</completion_date>
  <primary_completion_date type="Anticipated">December 2022</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Neonatal hypoglycemia</measure>
    <time_frame>2-3 hours postpartum</time_frame>
    <description>about 2-3 hours postpartum the neonate will have a capillary glucose test</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Maternal glycemic control during labor</measure>
    <time_frame>24 hours</time_frame>
    <description>During labor glucose level will be obtained every hour. Average glucose level during labor will be calculated after labor.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Maternal urine ketones</measure>
    <time_frame>1 hour</time_frame>
    <description>Immediately post partum maternal urine will be checked for ketones</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Total amount of regular insulin during labor</measure>
    <time_frame>24 hours</time_frame>
    <description>The total amount of regular insulin during labor will be calculated post partum</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mode of delivery</measure>
    <time_frame>1 hour</time_frame>
    <description>Mode of delivery</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Length of delivery</measure>
    <time_frame>24 hours</time_frame>
    <description>Length of delivery</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Breastfeeding</measure>
    <time_frame>48 hours</time_frame>
    <description>How many women breastfed in every study group</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Neonatal APGAR score</measure>
    <time_frame>5 minutes</time_frame>
    <description>Neonatal APGAR score</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Umbilical cord PH</measure>
    <time_frame>30 minutes</time_frame>
    <description>Umbilical cord PH</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Umbilical cord glucose level</measure>
    <time_frame>30 minutes</time_frame>
    <description>Umbilical cord glucose level</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The need for neonatal IV glucose infusion</measure>
    <time_frame>48 hours</time_frame>
    <description>The need for neonatal IV glucose infusion</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Neonatal jaundice</measure>
    <time_frame>48 hours</time_frame>
    <description>Neonatal jaundice- hyperbilirubinemia</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Length of neonatal hospital stay</measure>
    <time_frame>30 days</time_frame>
    <description>Length of neonatal hospital stay</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>NICU admission</measure>
    <time_frame>48 hours</time_frame>
    <description>NICU admission</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">200</enrollment>
  <condition>Obstetric Labor</condition>
  <condition>Pregnancy in Diabetics</condition>
  <arm_group>
    <arm_group_label>glucose solution and insulin</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Participants will receive intravenous saline solution boosted with 5% glucose + 8 units regular insulin in a rate of 125 mL/h.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>glucose solution only</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Participants will receive intravenous saline solution boosted with 5% glucose in a rate of 125 mL/h.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>glucose solution and Insulin</intervention_name>
    <description>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.&#xD;
Glucose level between 100-140 mg/dL will be treated with additional intravenous insulin, 1 units/hour.&#xD;
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.&#xD;
Glucose level between 161-200 mg/dL will be treated with intravenous insulin, 4 units/hour.&#xD;
Glucose level above 200 mg/dL will be treated with intravenous insulin, 6 units/hour.</description>
    <arm_group_label>glucose solution and insulin</arm_group_label>
    <arm_group_label>glucose solution only</arm_group_label>
    <other_name>Group 1</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>glucose solution only</intervention_name>
    <description>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.</description>
    <arm_group_label>glucose solution and insulin</arm_group_label>
    <other_name>Group 2</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  &gt;37 weeks gestation&#xD;
&#xD;
          -  gestational diabetes mellitus according to Carpenter and Coustan&#xD;
&#xD;
          -  pregestational diabetes mellitus&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Intrauterine fetal death&#xD;
&#xD;
          -  estimated fetal weight&lt;10p&#xD;
&#xD;
          -  multiple gestation&#xD;
&#xD;
          -  major fetal malformations&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Gali Gali, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>HaEmemk Medical Center, Afula, Israel.</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Gali Gali, MD</last_name>
    <phone>972-4-6494035</phone>
    <email>galit_ga@clalit.org.il</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Raed Salim, MD</last_name>
    <phone>972-4-6494355</phone>
    <email>salim_ra@clalit.org.il</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>HaEmek medical center</name>
      <address>
        <city>Afula</city>
        <zip>18101</zip>
        <country>Israel</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>galit Garmi, MD</last_name>
      <phone>97246494335</phone>
      <email>galit_ga@clalit.org.il</email>
    </contact>
  </location>
  <location_countries>
    <country>Israel</country>
  </location_countries>
  <reference>
    <citation>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.</citation>
    <PMID>729447</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>22355019</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>19832834</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>18463375</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>19465234</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>18664297</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>22357187</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>21357346</PMID>
  </reference>
  <results_reference>
    <citation>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.</citation>
    <PMID>10445833</PMID>
  </results_reference>
  <results_reference>
    <citation>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.</citation>
    <PMID>17126946</PMID>
  </results_reference>
  <results_reference>
    <citation>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.</citation>
    <PMID>2137758</PMID>
  </results_reference>
  <results_reference>
    <citation>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.</citation>
    <PMID>11105967</PMID>
  </results_reference>
  <results_reference>
    <citation>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.</citation>
    <PMID>10735458</PMID>
  </results_reference>
  <results_reference>
    <citation>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.</citation>
    <PMID>23538268</PMID>
  </results_reference>
  <results_reference>
    <citation>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.</citation>
    <PMID>7148898</PMID>
  </results_reference>
  <verification_date>April 2022</verification_date>
  <study_first_submitted>September 4, 2017</study_first_submitted>
  <study_first_submitted_qc>September 5, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 6, 2017</study_first_posted>
  <last_update_submitted>April 4, 2022</last_update_submitted>
  <last_update_submitted_qc>April 4, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">April 5, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>HaEmek Medical Center, Israel</investigator_affiliation>
    <investigator_full_name>Gali Garmy</investigator_full_name>
    <investigator_title>Dr Gali Garmi</investigator_title>
  </responsible_party>
  <keyword>Gestational diabetes mellitus</keyword>
  <keyword>Pre-gestational diabetes mellitus</keyword>
  <keyword>Treatment</keyword>
  <keyword>Neonatal hypoglycemia</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pregnancy in Diabetics</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pharmaceutical Solutions</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03273881
org study id: 0056-17-EMC
nct id: NCT03273881
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
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).
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Neonatal hypoglycemia
time frame: 2-3 hours postpartum
description: about 2-3 hours postpartum the neonate will have a capillary glucose test
measure: Maternal glycemic control during labor
time frame: 24 hours
description: During labor glucose level will be obtained every hour. Average glucose level during labor will be calculated after labor.
measure: Maternal urine ketones
time frame: 1 hour
description: Immediately post partum maternal urine will be checked for ketones
measure: Total amount of regular insulin during labor
time frame: 24 hours
description: The total amount of regular insulin during labor will be calculated post partum
measure: Mode of delivery
time frame: 1 hour
description: Mode of delivery
measure: Length of delivery
time frame: 24 hours
description: Length of delivery
measure: Breastfeeding
time frame: 48 hours
description: How many women breastfed in every study group
measure: Neonatal APGAR score
time frame: 5 minutes
description: Neonatal APGAR score
measure: Umbilical cord PH
time frame: 30 minutes
description: Umbilical cord PH
measure: Umbilical cord glucose level
time frame: 30 minutes
description: Umbilical cord glucose level
measure: The need for neonatal IV glucose infusion
time frame: 48 hours
description: The need for neonatal IV glucose infusion
measure: Neonatal jaundice
time frame: 48 hours
description: Neonatal jaundice- hyperbilirubinemia
measure: Length of neonatal hospital stay
time frame: 30 days
description: Length of neonatal hospital stay
measure: NICU admission
time frame: 48 hours
description: NICU admission
arm group label: glucose solution and insulin
arm group type: Active Comparator
description: Participants will receive intravenous saline solution boosted with 5% glucose + 8 units regular insulin in a rate of 125 mL/h.
arm group label: glucose solution only
arm group type: Active Comparator
description: Participants will receive intravenous saline solution boosted with 5% glucose in a rate of 125 mL/h.
intervention type: Drug
intervention name: glucose solution and Insulin
description: 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.
arm group label: glucose solution and insulin
arm group label: glucose solution only
other name: Group 1
intervention type: Drug
intervention name: glucose solution only
description: 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.
arm group label: glucose solution and insulin
other name: Group 2
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 60 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Gali Gali, MD
role: Principal Investigator
affiliation: HaEmemk Medical Center, Afula, Israel.
last name: Gali Gali, MD
phone: 972-4-6494035
email: galit_ga@clalit.org.il
last name: Raed Salim, MD
phone: 972-4-6494355
email: salim_ra@clalit.org.il
facility: 
status: Recruiting
contact: 
country: Israel
citation: 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.
PMID: 729447
citation: 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.
PMID: 22355019
citation: 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.
PMID: 19832834
citation: 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.
PMID: 18463375
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responsible party type: Principal Investigator
investigator affiliation: HaEmek Medical Center, Israel
investigator full name: Gali Garmy
investigator title: Dr Gali Garmi
mesh term: Pregnancy in Diabetics
mesh term: Pharmaceutical Solutions
sharing ipd: Undecided