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

NCT ID: NCT02590016

Last Updated: 2019-10-23

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-09-30
• Study Completion Date: 2021-11-30

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.

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.

Conditions

Gestational Diabetes; Hypoglycemia, Neonatal

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Insulin-glucose-infusion

Insulin-glucose-infusion is administered once active labour begins and will be continued until birth.

Group Type: EXPERIMENTAL

Insulin, Aspart

Intervention Type: DRUG

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.

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.

Group Type: ACTIVE_COMPARATOR

Insulin, Aspart

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: DRUG

Other Intervention Names

Novorapid

Eligibility 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)

• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Tampere University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Elina Kivekäs

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Elina Kivekäs, MD

Role: PRINCIPAL_INVESTIGATOR

Obstetrics and Gynecology Unit: Tampere University Hospital

Locations

Obstetrics and Gynecology Unit: Tampere University Hospital

Tampere, , Finland

Site Status: RECRUITING

Countries

Finland

Central Contacts

Jukka Uotila, prof

Role: CONTACT

jukka.uotila@uta.fi

+358331165244

Facility Contacts

Elina Kivekäs, MD

Role: primary

elina.kivekas@pshp.fi

+358331165244

References

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

PMID: 19225239 (View on PubMed)

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Reference Type: BACKGROUND

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Stenninger E, Schollin J, Aman J. Early postnatal hypoglycaemia in newborn infants of diabetic mothers. Acta Paediatr. 1997 Dec;86(12):1374-6. doi: 10.1111/j.1651-2227.1997.tb14916.x.

Reference Type: BACKGROUND

PMID: 9475319 (View on PubMed)

Ryan EA, Al-Agha R. Glucose control during labor and delivery. Curr Diab Rep. 2014 Jan;14(1):450. doi: 10.1007/s11892-013-0450-4.

Reference Type: BACKGROUND

PMID: 24292970 (View on PubMed)

Ryan EA, Sia WW, Khurana R, Marnoch CA, Nerenberg KA, Ghosh M. Glucose control during labour in diabetic women. J Obstet Gynaecol Can. 2012 Dec;34(12):1149-1157. doi: 10.1016/S1701-2163(16)35462-7.

Reference Type: BACKGROUND

PMID: 23231797 (View on PubMed)

Other Identifiers

R15050M

Identifier Type: -

Identifier Source: org_study_id