NCT02590016

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.

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
50

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Sep 2015

Longer than P75 for phase_4

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

Study Start

First participant enrolled

September 1, 2015

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

October 21, 2015

Completed
7 days until next milestone

First Posted

Study publicly available on registry

October 28, 2015

Completed
5.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2020

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2021

Completed
Last Updated

October 23, 2019

Status Verified

October 1, 2019

Enrollment Period

5.3 years

First QC Date

October 21, 2015

Last Update Submit

October 22, 2019

Conditions

Gestational DiabetesHypoglycemia, 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, AspartDRUG

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-infusionObservation

Eligibility Criteria

Sexfemale
Healthy VolunteersYes
Age GroupsChild (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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

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: 19432604BACKGROUND

  • 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: 22537519BACKGROUND

  • 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: 21163417BACKGROUND

  • 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: 19225239BACKGROUND

  • 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: 21078733BACKGROUND

  • 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: 9475319BACKGROUND

  • 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: 24292970BACKGROUND

  • 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: 23231797BACKGROUND

MeSH Terms

Conditions

Diabetes, GestationalHypoglycemia

Interventions

Insulin Aspart

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Insulin, Short-ActingInsulinsPancreatic HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPeptidesAmino 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

+358331165244jukka.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)