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Glucose Control During Labour in Gestational Diabetes Mellitus With Insulin Treatment: A Randomized Controlled Trial

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ClinicalTrials.gov Identifier: NCT02590016
Recruitment Status : Recruiting
First Posted : October 28, 2015
Last Update Posted : October 23, 2019
Sponsor:
Information provided by (Responsible Party):
Elina Kivekäs, Tampere University Hospital

Brief Summary:
Pregnant women with gestational diabetes who are treated with insulin and their daily insulin dose is 30 IU or more will be randomized into two groups. Active treatment group will receive insulin-glucose-infusion during labour. In the observational group, blood glucose level during labour will be monitored and insulin-glucose-infusion is started only if needed. The hypothesis is that there will not be a difference in rate of hypoglycemia between the two groups and that the proportion of observational group participants that need infusion is low.

Condition or disease Intervention/treatment Phase
Gestational Diabetes Hypoglycemia, Neonatal Drug: Insulin, Aspart Phase 4

Detailed Description:

Intrapartum blood glucose level has negative correlation to neonatal blood glucose level in type 1 diabetics. In gestational diabetes the correlation is less clear. In the view of current knowledge, it seems that moderately elevated intrapartum blood glucose may not cause neonatal hypoglycemia. There is no consensus of how to treat intrapartum blood glucose level in gestational diabetics. Some studies have implied that most of mothers with gestational diabetes would have normal blood glucose level during labour and hence would not need any intervention if their daily insulin dosage is less than 0,5-1 IU/kg.

Study participants are recruited into the study at Tampere University Hospital Maternity Ward when their daily insulin dose exceeds 30 IU. Randomization is done at 37th gestational week, if vaginal delivery is planned, and HbA1c is measured. Randomization envelope is opened at the delivery ward when active labour begins and treatment of blood glucose level is carried out accordingly. If insulin dose is 1 IU/kg or more, the participant is treated as in active treatment group despite of result of randomization. All neonates will receive milk substitute after birth in labour ward. Plasma glucose is measured immediately if neonate has symptoms of low blood sugar. If not, plasma glucose is measured approximately two hours after birth and after that every 4 hours until plasma glucose is 3,0 mmol/l or more in three consecutive measurements.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Glucose Control During Labour in Gestational Diabetes Mellitus With Insulin Treatment: Insulin-Glucose-Infusion Versus Observational Approach - Is There a Difference in Neonatal Hypoglycemia Rate?
Study Start Date : September 2015
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : November 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hypoglycemia

Arm Intervention/treatment
Experimental: Insulin-glucose-infusion
Insulin-glucose-infusion is administered once active labour begins and will be continued until birth.
Drug: Insulin, Aspart
Insulin aspart Novorapid® Penfill 40 IU/0,4 ml is diluted into 1000ml of 0,9 % sodium chloride (NaCl). Infusion is started at rate 48 ml/l, which equates insulin dosing at rate of 2 IU/h. Glucose infusion is started simultaneously. 5 ml of potassium chloride (KCl) is added to 500 ml of 10 % Glucose solution. Infusion rate is 100 ml/h giving glucose infusion rate of 10 g/l. Plasma glucose level is measured every 1-2 hours and infusion rate of insulin is increased by 6ml/h if plasma glucose is more than 7,5 mmol/l and decreased by 6 mmol/h if plasma glucose is below 4 mmol/l.
Other Name: Novorapid

Active Comparator: Observation
Plasma glucose level is measured every 1-2 hours during active labour and insulin-glucose-infusion is started if plasma glucose level exceeds 7,5 mmol/l in two subsequent measurements.
Drug: Insulin, Aspart
Insulin aspart Novorapid® Penfill 40 IU/0,4 ml is diluted into 1000ml of 0,9 % sodium chloride (NaCl). Infusion is started at rate 48 ml/l, which equates insulin dosing at rate of 2 IU/h. Glucose infusion is started simultaneously. 5 ml of potassium chloride (KCl) is added to 500 ml of 10 % Glucose solution. Infusion rate is 100 ml/h giving glucose infusion rate of 10 g/l. Plasma glucose level is measured every 1-2 hours and infusion rate of insulin is increased by 6ml/h if plasma glucose is more than 7,5 mmol/l and decreased by 6 mmol/h if plasma glucose is below 4 mmol/l.
Other Name: Novorapid




Primary Outcome Measures :
  1. Neonatal hypoglycemia [ Time Frame: within 48 hours after birth ]
    Neonatal plasma blood glucose < 3 mmol/l


Secondary Outcome Measures :
  1. Moderate neonatal hypoglycemia [ Time Frame: within 48 hours after birth ]
    Neonatal plasma blood glucose < 2,6 mmol/l

  2. Severe neonatal hypoglycemia [ Time Frame: within 48 hours after birth ]
    Neonatal plasma blood glucose <2,2 mmol/l and/or demand of treatment

  3. Duration of neonatal blood glucose monitoring [ Time Frame: within a week after birth ]
  4. Proportion of participants needing insulin-glucose-infusion in the observational arm [ Time Frame: during active labour ]


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • pregnant women with gestational diabetes mellitus and daily insulin dosage of 30 IU or more

Exclusion Criteria:

  • planned caesarean section,
  • premature birth (< 37 gestational weeks)

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): NCT02590016


Contacts
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Contact: Jukka Uotila, prof +358331165244 jukka.uotila@uta.fi

Locations
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Finland
Obstetrics and Gynecology Unit: Tampere University Hospital Recruiting
Tampere, Finland, 33521
Contact: Elina Kivekäs, MD    +358331165244    elina.kivekas@pshp.fi   
Sponsors and Collaborators
Tampere University Hospital
Investigators
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Principal Investigator: Elina Kivekäs, MD Obstetrics and Gynecology Unit: Tampere University Hospital

Publications:

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Responsible Party: Elina Kivekäs, MD, Tampere University Hospital
ClinicalTrials.gov Identifier: NCT02590016     History of Changes
Other Study ID Numbers: R15050M
First Posted: October 28, 2015    Key Record Dates
Last Update Posted: October 23, 2019
Last Verified: October 2019
Additional relevant MeSH terms:
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Diabetes, Gestational
Diabetes Mellitus
Hypoglycemia
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Pregnancy Complications
Insulin
Insulin, Globin Zinc
Insulin Aspart
Hypoglycemic Agents
Physiological Effects of Drugs