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

NCT02590016 | Unknown Phase 4 DMC

• 1 other identifier: R15050M
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Gestational Diabetes; Hypoglycemia, Neonatal

Outcome Measures

Primary Outcomes (1)

• Neonatal hypoglycemia

  Neonatal plasma blood glucose \< 3 mmol/l

  within 48 hours after birth

Secondary Outcomes (4)

• Moderate neonatal hypoglycemia

  within 48 hours after birth

• Severe neonatal hypoglycemia

  within 48 hours after birth

• Duration of neonatal blood glucose monitoring

  within a week after birth

• Proportion of participants needing insulin-glucose-infusion in the observational arm

  during active labour

Study Arms (2)

Insulin-glucose-infusion

EXPERIMENTAL

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

Drug: Insulin, Aspart

Observation

ACTIVE COMPARATOR

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

Interventions

Insulin, Aspart 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.

Also known as: Novorapid

Insulin-glucose-infusion; Observation

Eligibility Criteria

• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Tampere University Hospital: lead

Study Sites (1)

Obstetrics and Gynecology Unit: Tampere University Hospital

Tampere, 33521, Finland

RECRUITING

Related 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.

  PMID: 19432604 BACKGROUND

• 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.

  PMID: 22537519 BACKGROUND

• 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.

  PMID: 21163417 BACKGROUND

• 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.

  PMID: 19225239 BACKGROUND

• 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.

  PMID: 21078733 BACKGROUND

• 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.

  PMID: 9475319 BACKGROUND

• 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.

  PMID: 24292970 BACKGROUND

• 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.

  PMID: 23231797 BACKGROUND

MeSH Terms

Conditions

Diabetes, Gestational; Hypoglycemia

Interventions

Insulin Aspart

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Insulin, Short-Acting; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• Elina Kivekäs, MD

  Obstetrics and Gynecology Unit: Tampere University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jukka Uotila, prof

CONTACT

+358331165244; jukka.uotila@uta.fi

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: October 21, 2015
• First Posted: October 28, 2015
• Study Start: September 1, 2015
• Primary Completion: December 1, 2020
• Study Completion: November 1, 2021
• Last Updated: October 23, 2019

Record last verified: 2019-10

Locations

FI (1)