Gestational DiabetesPhase 4NCT02590016
Glucose Control During Labour in Gestational Diabetes Mellitus With Insulin Treatment: A Randomized Controlled Trial
A Phase 4 study testing Insulin, Aspart in people with Gestational Diabetes and Hypoglycemia, Neonatal, run by Tampere University Hospital at 1 site in Finland.
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. Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Gestational Diabetes, Hypoglycemia, Neonatal
- What is being tested?
- Insulin, Aspart
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteFinland
- Study dates
- Sep 2015to Nov 2021
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- pregnant women with gestational diabetes mellitus and daily insulin dosage of 30 IU or more
Who cannot join
- planned caesarean section,
- premature birth (< 37 gestational weeks)
Trial locations and contacts
1 site in 1 country.
Finland1 site, 1 recruiting
- Recruiting
Obstetrics and Gynecology Unit: Tampere University Hospital
Tampere, 33521
Elina Kivekäs, MD, +358331165244, elina.kivekas@pshp.fi
About this study
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?
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.
Read the 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
- Being tested
- Insulin, Aspart
- Medical subject headings
- Diabetes, Gestational, Hypoglycemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Insulin, AspartDrug
Also called Novorapid
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.
| Study group | Role | What they receive |
|---|---|---|
| Insulin-glucose-infusion | Experimental | Insulin-glucose-infusion is administered once active labour begins and will be continued until birth. Receives: 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. Receives: Drug: Insulin, Aspart |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neonatal hypoglycemia
Neonatal plasma blood glucose < 3 mmol/l
Measured: within 48 hours after birth
Secondary outcomes (4)
Moderate neonatal hypoglycemia
Neonatal plasma blood glucose < 2,6 mmol/l
Measured: within 48 hours after birth
Severe neonatal hypoglycemia
Neonatal plasma blood glucose <2,2 mmol/l and/or demand of treatment
Measured: within 48 hours after birth
Duration of neonatal blood glucose monitoring
Measured: within a week after birth
Proportion of participants needing insulin-glucose-infusion in the observational arm
Measured: during active labour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2015 (estimated)
- Study startSep 2015
- Primary completionDec 2020 (estimated)
- Study completionNov 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Gestational DiabetesStudies of the same condition, open and under way.
- More trials run by Tampere University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tampere University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elina Kivekäs, Tampere University Hospital
- Investigators
- Elina Kivekäs, MD, Principal investigator, Obstetrics and Gynecology Unit: Tampere University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02590016
- Sponsor's protocol ID
- R15050M
- Status last verified
- Oct 2019
- First submitted
- 21 Oct 2015
- Last updated
- 23 Oct 2019
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 19432604Flores-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.
PubMed 22537519Garabedian 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.
PubMed 21163417Maayan-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.
PubMed 19225239Metzger 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.
PubMed 21078733Stenninger 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.
PubMed 9475319Ryan 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.
PubMed 24292970Ryan 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.
PubMed 23231797
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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?
- ClinicalTrials.gov ID
- NCT02590016
- Acronym / sponsor ID
- R15050M
- Conditions
- Gestational Diabetes, Hypoglycemia, Neonatal
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Tampere University HospitalUniversity, hospital or other
- Study start
- Sep 2015
- Primary completion
- Dec 2020 (estimated)
- Study completion
- Nov 2021 (estimated)
- First posted
- 28 Oct 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Insulin-glucose-infusion | Experimental | Drug: Insulin, AspartInsulin-glucose-infusion is administered once active labour begins and will be continued until birth. |
| Observation | Active comparator | Drug: Insulin, AspartPlasma 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. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- pregnant women with gestational diabetes mellitus and daily insulin dosage of 30 IU or more
Key exclusion criteria (2 listed)
- planned caesarean section,
- premature birth (< 37 gestational weeks)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Insulin, AspartAlso: NovorapidInsulin 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. | Drug | Insulin-glucose-infusion, Observation |
Primary outcome
Neonatal hypoglycemia
Time frame: within 48 hours after birth
Neonatal plasma blood glucose < 3 mmol/l
4 secondary outcomes
Moderate neonatal hypoglycemia
Time frame: within 48 hours after birth
Severe neonatal hypoglycemia
Time frame: within 48 hours after birth
Duration of neonatal blood glucose monitoring
Time frame: within a week after birth
Proportion of participants needing insulin-glucose-infusion in the observational arm
Time frame: during active labour
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2019.
- Background: PubMed 19432604Barrett 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.
- Background: PubMed 22537519Flores-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.
- Background: PubMed 21163417Garabedian 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.
- Background: PubMed 19225239Maayan-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.
- Background: PubMed 21078733Metzger 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.
- Background: PubMed 9475319Stenninger 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.
- Background: PubMed 24292970Ryan 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.
- Background: PubMed 23231797Ryan 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.
Related trials for Gestational Diabetes
Active, not recruiting
Effect of Probiotics on Insulin Sensitivity in Overweight and Obese Pregnancy
Obesity & Overweight, Gestational Diabetes Mellitus (GDM)
Not yet recruitingObservational study
Ultrasound Assessment Of Gastric Volume In Pregnant Women Undergoing Elective Cesarean Section
Gestational Diabetes Mellitus (GDM), Obstetric Anesthesia
Active, not recruitingPhase 2
Effectiveness Study of a Lifestyle Intervention Versus Metformin in Mothers With Recent Gestational Diabetes
Weight Loss, Gestational Diabetes Mellitus in Pregnancy
Not yet recruiting
STRONG: SMART Trial
Gestational Diabetes Mellitus (GDM)
Not yet recruiting
A Study to Lower Blood Pressure One Year After Childbirth in Women Who Had Preeclampsia
Adverse Pregnancy Outcomes, Cardiovascular Diseases
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Elina Kivekäs, MD principal investigator
Obstetrics and Gynecology Unit: Tampere University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Insulin, Aspart in people with Gestational Diabetes and Hypoglycemia, Neonatal, run by Tampere University Hospital at 1 site in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jukka Uotila, prof (+358331165244, jukka.uotila@uta.fi), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Neonatal hypoglycemia (time frame: within 48 hours after birth). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02590016, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Oct 2019.