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

Gestational Diabetes Clinical Trial

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?

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02590016
• Other study ID #: R15050M
• Status: Recruiting
• Phase: Phase 4
• Start date: September 2015
• Est. completion date: November 2021

Study information

• Verified date: October 2019
• Source: Tampere University Hospital
• Contact: Jukka Uotila, prof
• Phone: +358331165244
• Email: jukka.uotila[@]uta.fi
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: November 2021
• Est. primary completion date: December 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: N/A and older

Eligibility

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)

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes, Gestational
• Gestational Diabetes
• Hypoglycemia
• Hypoglycemia, Neonatal

Intervention

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.

Locations

Country	Name	City	State
Finland	Obstetrics and Gynecology Unit: Tampere University Hospital	Tampere

Sponsors (1)

Lead Sponsor	Collaborator
Tampere University Hospital

Country where clinical trial is conducted

Finland, 

References & Publications (8)

Barrett HL, Morris J, McElduff A. Watchful waiting: a management protocol for maternal glycaemia in the peripartum period. Aust N Z J Obstet Gynaecol. 2009 Apr;49(2):162-7. doi: 10.1111/j.1479-828X.2009.00969.x. — View Citation

Flores-le Roux JA, Sagarra E, Benaiges D, Hernandez-Rivas E, Chillaron JJ, Puig de Dou J, Mur A, Lopez-Vilchez MA, Pedro-Botet J. A prospective evaluation of neonatal hypoglycaemia in infants of women with gestational diabetes mellitus. Diabetes Res Clin Pract. 2012 Aug;97(2):217-22. doi: 10.1016/j.diabres.2012.03.011. Epub 2012 Apr 24. — View Citation

Garabedian C, Deruelle P. Delivery (timing, route, peripartum glycemic control) in women with gestational diabetes mellitus. Diabetes Metab. 2010 Dec;36(6 Pt 2):515-21. doi: 10.1016/j.diabet.2010.11.005. Review. — View Citation

Maayan-Metzger A, Lubin D, Kuint J. Hypoglycemia rates in the first days of life among term infants born to diabetic mothers. Neonatology. 2009;96(2):80-5. doi: 10.1159/000203337. Epub 2009 Feb 19. — View Citation

Metzger BE, Persson B, Lowe LP, Dyer AR, Cruickshank JK, Deerochanawong C, Halliday HL, Hennis AJ, Liley H, Ng PC, Coustan DR, Hadden DR, Hod M, Oats JJ, Trimble ER; HAPO Study Cooperative Research Group. Hyperglycemia and adverse pregnancy outcome study: neonatal glycemia. Pediatrics. 2010 Dec;126(6):e1545-52. doi: 10.1542/peds.2009-2257. Epub 2010 Nov 15. — View Citation

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. Review. — View Citation

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. — View Citation

Stenninger E, Schollin J, Aman J. Early postnatal hypoglycaemia in newborn infants of diabetic mothers. Acta Paediatr. 1997 Dec;86(12):1374-6. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Neonatal hypoglycemia	Neonatal plasma blood glucose < 3 mmol/l	within 48 hours after birth
Secondary	Moderate neonatal hypoglycemia	Neonatal plasma blood glucose < 2,6 mmol/l	within 48 hours after birth
Secondary	Severe neonatal hypoglycemia	Neonatal plasma blood glucose <2,2 mmol/l and/or demand of treatment	within 48 hours after birth
Secondary	Duration of neonatal blood glucose monitoring		within a week after birth
Secondary	Proportion of participants needing insulin-glucose-infusion in the observational arm		during active labour