NCT03273881

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 4, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 6, 2017

Completed
2 months until next milestone

Study Start

First participant enrolled

October 31, 2017

Completed
6.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
Last Updated

October 11, 2023

Status Verified

October 1, 2023

Enrollment Period

6.2 years

First QC Date

September 4, 2017

Last Update Submit

October 8, 2023

Conditions

Obstetric LaborPregnancy in Diabetics

Keywords

Gestational diabetes mellitusPre-gestational diabetes mellitusTreatmentNeonatal hypoglycemia

Outcome Measures

Primary Outcomes (1)

  • Neonatal hypoglycemia

    about 2-3 hours postpartum the neonate will have a capillary glucose test

    2-3 hours postpartum

Secondary Outcomes (13)

  • Maternal glycemic control during labor

    24 hours

  • Maternal urine ketones

    1 hour

  • Total amount of regular insulin during labor

    24 hours

  • Mode of delivery

    1 hour

  • Length of delivery

    24 hours

  • +8 more secondary outcomes

Study Arms (2)

glucose solution and insulin

ACTIVE COMPARATOR

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 InsulinDrug: glucose solution only

glucose solution only

ACTIVE COMPARATOR

Participants will receive intravenous saline solution boosted with 5% glucose in a rate of 125 mL/h.

Drug: glucose solution and Insulin

Interventions

glucose solution and InsulinDRUG

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
glucose solution and insulinglucose solution only
glucose solution onlyDRUG

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
glucose solution and insulin

Eligibility Criteria

Age18 Years - 60 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • \>37 weeks gestation
  • gestational diabetes mellitus according to Carpenter and Coustan
  • pregestational diabetes mellitus

You may not qualify if:

  • Intrauterine fetal death
  • estimated fetal weight\<10p
  • multiple gestation
  • major fetal malformations

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

HaEmek medical center

Afula, 18101, Israel

RECRUITING

Related Publications (15)

  • 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: 729447BACKGROUND

  • 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: 22355019BACKGROUND

  • 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: 19832834BACKGROUND

  • 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: 18463375BACKGROUND

  • 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.

    PMID: 19465234BACKGROUND

  • 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.

    PMID: 18664297BACKGROUND

  • 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.

    PMID: 22357187BACKGROUND

  • 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.

    PMID: 21357346BACKGROUND

  • 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.

    PMID: 10445833RESULT

  • 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.

    PMID: 17126946RESULT

  • 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.

    PMID: 2137758RESULT

  • 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.

    PMID: 11105967RESULT

  • 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.

    PMID: 10735458RESULT

  • 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.

    PMID: 23538268RESULT

  • 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.

    PMID: 7148898RESULT

MeSH Terms

Conditions

Pregnancy in DiabeticsDiabetes, Gestational

Interventions

Insulin

Condition Hierarchy (Ancestors)

Pregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesDiabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

ProinsulinInsulinsPancreatic HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPeptidesAmino Acids, Peptides, and Proteins

Study Officials

  • Gali Gali, MD

    HaEmemk Medical Center, Afula, Israel.

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Gali Gali, MD

CONTACT

972-4-6494035galit_ga@clalit.org.il

Raed Salim, MD

CONTACT

972-4-6494355salim_ra@clalit.org.il

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr Gali Garmi

Study Record Dates

First Submitted

September 4, 2017

First Posted

September 6, 2017

Study Start

October 31, 2017

Primary Completion

December 31, 2023

Study Completion

December 31, 2023

Last Updated

October 11, 2023

Record last verified: 2023-10

Locations

IL(1)