Obstetric LaborNCT03273881
Intrapartum Glucose and Insulin Compared to Glucose Alone in Diabetic Women
A study testing glucose solution and Insulin and glucose solution only in people with Obstetric Labor and Pregnancy in Diabetics, run by HaEmek Medical Center, Israel at 1 site in Israel.
Trial summary
This study aims to examine the effect of intrapartum treatment of diabetic women with combined glucose and constant insulin infusion compared to glucose alone on the incidence of neonatal hypoglycemia. Read more about this study
- Who is it for?
- Ages 18 to 60 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Obstetric Labor, Pregnancy in Diabetics
- What is being tested?
- glucose solution and Insulin and glucose solution only
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteIsrael
- Study dates
- 31 Oct 2017to 31 Dec 2023
- Phase
- Interventional
- 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 18 to 60 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- >37 weeks gestation
- gestational diabetes mellitus according to Carpenter and Coustan
- pregestational diabetes mellitus
Who cannot join
- Intrauterine fetal death
- estimated fetal weight<10p
- multiple gestation
- major fetal malformations
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
HaEmek medical center
Afula, 18101
galit Garmi, MD, 97246494335, galit_ga@clalit.org.il
About this study
Official title: Effect of Intrapartum Glucose With Compared to Without Constant Intravenous Insulin on Neonatal Hypoglycemia Among Diabetic Women. A Randomized Controlled Trial
This study aims to examine the effect of intrapartum treatment of diabetic women with combined glucose and constant insulin infusion compared to glucose alone on the incidence of neonatal hypoglycemia. Pregnant women with diabetes in pregnancy will be randomly divided during labor to 2 groups: group 1, will receive intravenous glucose with constant insulin infusion; group 2 will receive intravenous glucose alone. The primary outcome is the incidence of neonatal hypoglycemia.
Read the detailed description
About 2 to 9% of pregnant women are diagnosed with gestational diabetes. Peripartum complications attributed to diabetes include: birth trauma, neonatal hypoglycemia and hyperinsulinemia and neonatal hyperbilirubinemia. The incidence of neonatal hypoglycemia is about 40%. Strict glycemic control may lower the risk of neonatal complications. There is a lack of evidence on how to manage women with diabetes during labor. Previous studies recommended the use of intravenous saline solution boosted with 5% glucose and insulin as needed, glucose 5% with constant insulin infusion and others recommended the use lactated Ringer's solution. Most of these studies are either retrospective or have a small number of participants.
In this study we will examine the effect of 2 different protocols on glycemic control during labor and the immediate neonatal period. Women in group 1, will receive intravenous saline solution boosted with 5% glucose and constant insulin infusion. Women in group 2, will receive intravenous saline solution boosted with 5% glucose alone. The desirable intrapartum glucose level will be 70 to 100 mg/dL. Glucose levels will be checked hourly. Women in both groups will receive additional insulin infusion in cases of glucose levels above 100 mg/dL. Additionally, the 5% glucose solution will be substitute with lactated Ringer's solution in cases of glucose levels above 140 mg/dL.
Intravenous fluid regimens will be assigned according to a computer randomization sequence generation program. Women will randomly assigned to the 2 groups in a 1:1 ratio. The randomization sequence results will be kept in the delivery ward in a closed study box. Site investigators will enroll participants after confirming eligibility. The sequence will be concealed until intervention is assigned (and after obtaining a signed informed consent).
Our hypothesis is that 5% glucose combined with constant insulin infusion will achieve better glycemic control and thus will lead to lower rate of neonatal hypoglycemia. In order to detect a reduction of neonatal hypoglycemia from 40% to 20%, 182 women will be needed in both groups in order to achieve a level of significance of 95% (α, 2-sided = 0.05) and a power of 80% (β = 0.2).
- Conditions
- Obstetric Labor, Pregnancy in Diabetics
- Being tested
- glucose solution and Insulin, glucose solution only
- Keywords
- Gestational diabetes mellitus, Pre-gestational diabetes mellitus, Treatment, Neonatal hypoglycemia
- Medical subject headings
- Pregnancy in Diabetics, Diabetes, Gestational
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
glucose solution and InsulinDrug
Also called Group 1
Women in group 1, will receive intravenous saline solution boosted with 5% glucose combined with 8 units of insulin at a rate of 125mL/h. The desirable intrapartum glucose level will be 70 to 100 mg/dL. Glucose levels will be checked hourly.
Glucose level between 100-140 mg/dL will be treated with additional intravenous insulin, 1 units/hour.
Glucose level between 141-160 mg/dL will be treated with intravenous insulin, 2 units/hour. Additionally, the 5% glucose solution will be substitute with lactated Ringer's solution.
Glucose level between 161-200 mg/dL will be treated with intravenous insulin, 4 units/hour.
Glucose level above 200 mg/dL will be treated with intravenous insulin, 6 units/hour.
glucose solution onlyDrug
Also called Group 2
Women in group 2, will receive intravenous saline solution boosted with 5% glucose only, at a rate of 125mL/h. Women in this group will be treated similar to group 1 if glucose levels crossed over 100 mg/dL.
| Study group | Role | What they receive |
|---|---|---|
| glucose solution and insulin | Active comparator | Participants will receive intravenous saline solution boosted with 5% glucose + 8 units regular insulin in a rate of 125 mL/h. Receives: Drug: glucose solution and Insulin; Drug: glucose solution only |
| glucose solution only | Active comparator | Participants will receive intravenous saline solution boosted with 5% glucose in a rate of 125 mL/h. Receives: Drug: glucose solution and Insulin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neonatal hypoglycemia
about 2-3 hours postpartum the neonate will have a capillary glucose test
Measured: 2-3 hours postpartum
Secondary outcomes (13)
Maternal glycemic control during labor
During labor glucose level will be obtained every hour. Average glucose level during labor will be calculated after labor.
Measured: 24 hours
Maternal urine ketones
Immediately post partum maternal urine will be checked for ketones
Measured: 1 hour
Total amount of regular insulin during labor
The total amount of regular insulin during labor will be calculated post partum
Measured: 24 hours
Mode of delivery
Mode of delivery
Measured: 1 hour
Length of delivery
Length of delivery
Measured: 24 hours
Breastfeeding
How many women breastfed in every study group
Measured: 48 hours
Neonatal APGAR score
Neonatal APGAR score
Measured: 5 minutes
Umbilical cord PH
Umbilical cord PH
Measured: 30 minutes
Umbilical cord glucose level
Umbilical cord glucose level
Measured: 30 minutes
The need for neonatal IV glucose infusion
The need for neonatal IV glucose infusion
Measured: 48 hours
Neonatal jaundice
Neonatal jaundice- hyperbilirubinemia
Measured: 48 hours
Length of neonatal hospital stay
Length of neonatal hospital stay
Measured: 30 days
NICU admission
NICU admission
Measured: 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2017
- Study start31 Oct 2017
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (15)Papers the sponsor has linked to this study.
- Other trials for Obstetric LaborStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- HaEmek Medical Center, Israel
- Sponsor type
- University, hospital or other
- Collaborators
- Holy Family Hospital, Nazareth, Israel
- Responsible party
- Principal investigator, Gali Garmy, HaEmek Medical Center, Israel
- Investigators
- Gali Gali, MD, Principal investigator, HaEmemk Medical Center, Afula, Israel.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03273881
- Sponsor's protocol ID
- 0056-17-EMC
- Status last verified
- Oct 2023
- First submitted
- 4 Sep 2017
- Last updated
- 11 Oct 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Soler NG, Soler SM, Malins JM. Neonatal morbidity among infants of diabetic mothers. Diabetes Care. 1978 Nov-Dec;1(6):340-50. doi: 10.2337/diacare.1.6.340.
PubMed 729447Sacks DA, Hadden DR, Maresh M, Deerochanawong C, Dyer AR, Metzger BE, Lowe LP, Coustan DR, Hod M, Oats JJ, Persson B, Trimble ER; HAPO Study Cooperative Research Group. Frequency of gestational diabetes mellitus at collaborating centers based on IADPSG consensus panel-recommended criteria: the Hyperglycemia and Adverse Pregnancy Outcome (HAPO) Study. Diabetes Care. 2012 Mar;35(3):526-8. doi: 10.2337/dc11-1641.
PubMed 22355019Taricco E, Radaelli T, Rossi G, Nobile de Santis MS, Bulfamante GP, Avagliano L, Cetin I. Effects of gestational diabetes on fetal oxygen and glucose levels in vivo. BJOG. 2009 Dec;116(13):1729-35. doi: 10.1111/j.1471-0528.2009.02341.x. Epub 2009 Oct 13.
PubMed 19832834HAPO Study Cooperative Research Group; Metzger BE, Lowe LP, Dyer AR, Trimble ER, Chaovarindr U, Coustan DR, Hadden DR, McCance DR, Hod M, McIntyre HD, Oats JJ, Persson B, Rogers MS, Sacks DA. Hyperglycemia and adverse pregnancy outcomes. N Engl J Med. 2008 May 8;358(19):1991-2002. doi: 10.1056/NEJMoa0707943.
PubMed 18463375Reece EA, Leguizamon G, Wiznitzer A. Gestational diabetes: the need for a common ground. Lancet. 2009 May 23;373(9677):1789-97. doi: 10.1016/S0140-6736(09)60515-8.
PubMed 19465234Ju H, Rumbold AR, Willson KJ, Crowther CA. Borderline gestational diabetes mellitus and pregnancy outcomes. BMC Pregnancy Childbirth. 2008 Jul 30;8:31. doi: 10.1186/1471-2393-8-31.
PubMed 18664297Catalano PM, McIntyre HD, Cruickshank JK, McCance DR, Dyer AR, Metzger BE, Lowe LP, Trimble ER, Coustan DR, Hadden DR, Persson B, Hod M, Oats JJ; HAPO Study Cooperative Research Group. The hyperglycemia and adverse pregnancy outcome study: associations of GDM and obesity with pregnancy outcomes. Diabetes Care. 2012 Apr;35(4):780-6. doi: 10.2337/dc11-1790. Epub 2012 Feb 22.
PubMed 22357187Committee on Fetus and Newborn; Adamkin DH. Postnatal glucose homeostasis in late-preterm and term infants. Pediatrics. 2011 Mar;127(3):575-9. doi: 10.1542/peds.2010-3851. Epub 2011 Feb 28.
PubMed 21357346Carron Brown S, Kyne-Grzebalski D, Mwangi B, Taylor R. Effect of management policy upon 120 Type 1 diabetic pregnancies: policy decisions in practice. Diabet Med. 1999 Jul;16(7):573-8. doi: 10.1046/j.1464-5491.1999.00124.x.
PubMed 10445833Kline GA, Edwards A. Antepartum and intra-partum insulin management of type 1 and type 2 diabetic women: Impact on clinically significant neonatal hypoglycemia. Diabetes Res Clin Pract. 2007 Aug;77(2):223-30. doi: 10.1016/j.diabres.2006.10.024. Epub 2006 Nov 28.
PubMed 17126946Lean ME, Pearson DW, Sutherland HW. Insulin management during labour and delivery in mothers with diabetes. Diabet Med. 1990 Feb;7(2):162-4. doi: 10.1111/j.1464-5491.1990.tb01352.x.
PubMed 2137758Balsells M, Corcoy R, Adelantado JM, Garcia-Patterson A, Altirriba O, de Leiva A. Gestational diabetes mellitus: metabolic control during labour. Diabetes Nutr Metab. 2000 Oct;13(5):257-62.
PubMed 11105967Hussain K, Sharief N. The inaccuracy of venous and capillary blood glucose measurement using reagent strips in the newborn period and the effect of haematocrit. Early Hum Dev. 2000 Feb;57(2):111-21. doi: 10.1016/s0378-3782(99)00060-2.
PubMed 10735458Hernandez-Rivas E, Flores-Le Roux JA, Benaiges D, Sagarra E, Chillaron JJ, Paya A, Puig-de Dou J, Goday A, Lopez-Vilchez MA, Pedro-Botet J. Gestational diabetes in a multiethnic population of Spain: clinical characteristics and perinatal outcomes. Diabetes Res Clin Pract. 2013 May;100(2):215-21. doi: 10.1016/j.diabres.2013.01.030. Epub 2013 Mar 26.
PubMed 23538268Carpenter MW, Coustan DR. Criteria for screening tests for gestational diabetes. Am J Obstet Gynecol. 1982 Dec 1;144(7):768-73. doi: 10.1016/0002-9378(82)90349-0.
PubMed 7148898
Study at a glance
From the registry record, last updated by the sponsor on 11 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Intrapartum Glucose With Compared to Without Constant Intravenous Insulin on Neonatal Hypoglycemia Among Diabetic Women. A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03273881
- Acronym / sponsor ID
- 0056-17-EMC
- Conditions
- Obstetric Labor, Pregnancy in Diabetics
- Keywords
- Gestational diabetes mellitus, Pre-gestational diabetes mellitus, Treatment, Neonatal hypoglycemia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- HaEmek Medical Center, IsraelUniversity, hospital or other
- Collaborators
- Holy Family Hospital, Nazareth, Israel
- Study start
- 31 Oct 2017 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 6 Sep 2017 (actual)
- 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.
This study aims to examine the effect of intrapartum treatment of diabetic women with combined glucose and constant insulin infusion compared to glucose alone on the incidence of neonatal hypoglycemia. Pregnant women with diabetes in pregnancy will be randomly divided during labor to 2 groups: group 1, will receive intravenous glucose with constant insulin infusion; group 2 will receive intravenous glucose alone. The primary outcome is the incidence of neonatal hypoglycemia.
Detailed description
About 2 to 9% of pregnant women are diagnosed with gestational diabetes. Peripartum complications attributed to diabetes include: birth trauma, neonatal hypoglycemia and hyperinsulinemia and neonatal hyperbilirubinemia. The incidence of neonatal hypoglycemia is about 40%. Strict glycemic control may lower the risk of neonatal complications. There is a lack of evidence on how to manage women with diabetes during labor. Previous studies recommended the use of intravenous saline solution boosted with 5% glucose and insulin as needed, glucose 5% with constant insulin infusion and others recommended the use lactated Ringer's solution. Most of these studies are either retrospective or have a small number of participants.
In this study we will examine the effect of 2 different protocols on glycemic control during labor and the immediate neonatal period. Women in group 1, will receive intravenous saline solution boosted with 5% glucose and constant insulin infusion. Women in group 2, will receive intravenous saline solution boosted with 5% glucose alone. The desirable intrapartum glucose level will be 70 to 100 mg/dL. Glucose levels will be checked hourly. Women in both groups will receive additional insulin infusion in cases of glucose levels above 100 mg/dL. Additionally, the 5% glucose solution will be substitute with lactated Ringer's solution in cases of glucose levels above 140 mg/dL.
Intravenous fluid regimens will be assigned according to a computer randomization sequence generation program. Women will randomly assigned to the 2 groups in a 1:1 ratio. The randomization sequence results will be kept in the delivery ward in a closed study box. Site investigators will enroll participants after confirming eligibility. The sequence will be concealed until intervention is assigned (and after obtaining a signed informed consent).
Our hypothesis is that 5% glucose combined with constant insulin infusion will achieve better glycemic control and thus will lead to lower rate of neonatal hypoglycemia. In order to detect a reduction of neonatal hypoglycemia from 40% to 20%, 182 women will be needed in both groups in order to achieve a level of significance of 95% (α, 2-sided = 0.05) and a power of 80% (β = 0.2).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| glucose solution and insulin | Active comparator | Drug: glucose solution and Insulin, Drug: glucose solution onlyParticipants will receive intravenous saline solution boosted with 5% glucose + 8 units regular insulin in a rate of 125 mL/h. |
| glucose solution only | Active comparator | Drug: glucose solution and InsulinParticipants will receive intravenous saline solution boosted with 5% glucose in a rate of 125 mL/h. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- >37 weeks gestation
- gestational diabetes mellitus according to Carpenter and Coustan
- pregestational diabetes mellitus
Key exclusion criteria (4 listed)
- Intrauterine fetal death
- estimated fetal weight<10p
- multiple gestation
- major fetal malformations
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 |
|---|---|---|
| glucose solution and InsulinAlso: Group 1Women in group 1, will receive intravenous saline solution boosted with 5% glucose combined with 8 units of insulin at a rate of 125mL/h. The desirable intrapartum glucose level will be 70 to 100 mg/dL. Glucose levels will be checked hourly. Glucose level between 100-140 mg/dL will be treated with additional intravenous insulin, 1 units/hour. Glucose level between 141-160 mg/dL will be treated with intravenous insulin, 2 units/hour. Additionally, the 5% glucose solution will be substitute with lactated Ringer's solution. Glucose level between 161-200 mg/dL will be treated with intravenous insulin, 4 units/hour. Glucose level above 200 mg/dL will be treated with intravenous insulin, 6 units/hour. | Drug | glucose solution and insulin, glucose solution only |
| glucose solution onlyAlso: Group 2Women in group 2, will receive intravenous saline solution boosted with 5% glucose only, at a rate of 125mL/h. Women in this group will be treated similar to group 1 if glucose levels crossed over 100 mg/dL. | Drug | glucose solution and insulin |
Primary outcome
Neonatal hypoglycemia
Time frame: 2-3 hours postpartum
about 2-3 hours postpartum the neonate will have a capillary glucose test
13 secondary outcomes
Maternal glycemic control during labor
Time frame: 24 hours
Maternal urine ketones
Time frame: 1 hour
Total amount of regular insulin during labor
Time frame: 24 hours
Mode of delivery
Time frame: 1 hour
Length of delivery
Time frame: 24 hours
Breastfeeding
Time frame: 48 hours
Neonatal APGAR score
Time frame: 5 minutes
Umbilical cord PH
Time frame: 30 minutes
Umbilical cord glucose level
Time frame: 30 minutes
The need for neonatal IV glucose infusion
Time frame: 48 hours
Neonatal jaundice
Time frame: 48 hours
Length of neonatal hospital stay
Time frame: 30 days
NICU admission
Time frame: 48 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Oct 2023.
- Background: PubMed 729447Soler NG, Soler SM, Malins JM. Neonatal morbidity among infants of diabetic mothers. Diabetes Care. 1978 Nov-Dec;1(6):340-50. doi: 10.2337/diacare.1.6.340.
- Background: PubMed 22355019Sacks DA, Hadden DR, Maresh M, Deerochanawong C, Dyer AR, Metzger BE, Lowe LP, Coustan DR, Hod M, Oats JJ, Persson B, Trimble ER; HAPO Study Cooperative Research Group. Frequency of gestational diabetes mellitus at collaborating centers based on IADPSG consensus panel-recommended criteria: the Hyperglycemia and Adverse Pregnancy Outcome (HAPO) Study. Diabetes Care. 2012 Mar;35(3):526-8. doi: 10.2337/dc11-1641.
- Background: PubMed 19832834Taricco E, Radaelli T, Rossi G, Nobile de Santis MS, Bulfamante GP, Avagliano L, Cetin I. Effects of gestational diabetes on fetal oxygen and glucose levels in vivo. BJOG. 2009 Dec;116(13):1729-35. doi: 10.1111/j.1471-0528.2009.02341.x. Epub 2009 Oct 13.
- Background: PubMed 18463375HAPO Study Cooperative Research Group; Metzger BE, Lowe LP, Dyer AR, Trimble ER, Chaovarindr U, Coustan DR, Hadden DR, McCance DR, Hod M, McIntyre HD, Oats JJ, Persson B, Rogers MS, Sacks DA. Hyperglycemia and adverse pregnancy outcomes. N Engl J Med. 2008 May 8;358(19):1991-2002. doi: 10.1056/NEJMoa0707943.
- Background: PubMed 19465234Reece EA, Leguizamon G, Wiznitzer A. Gestational diabetes: the need for a common ground. Lancet. 2009 May 23;373(9677):1789-97. doi: 10.1016/S0140-6736(09)60515-8.
- Background: PubMed 18664297Ju H, Rumbold AR, Willson KJ, Crowther CA. Borderline gestational diabetes mellitus and pregnancy outcomes. BMC Pregnancy Childbirth. 2008 Jul 30;8:31. doi: 10.1186/1471-2393-8-31.
- Background: PubMed 22357187Catalano PM, McIntyre HD, Cruickshank JK, McCance DR, Dyer AR, Metzger BE, Lowe LP, Trimble ER, Coustan DR, Hadden DR, Persson B, Hod M, Oats JJ; HAPO Study Cooperative Research Group. The hyperglycemia and adverse pregnancy outcome study: associations of GDM and obesity with pregnancy outcomes. Diabetes Care. 2012 Apr;35(4):780-6. doi: 10.2337/dc11-1790. Epub 2012 Feb 22.
- Background: PubMed 21357346Committee on Fetus and Newborn; Adamkin DH. Postnatal glucose homeostasis in late-preterm and term infants. Pediatrics. 2011 Mar;127(3):575-9. doi: 10.1542/peds.2010-3851. Epub 2011 Feb 28.
- Results publication: PubMed 10445833Carron Brown S, Kyne-Grzebalski D, Mwangi B, Taylor R. Effect of management policy upon 120 Type 1 diabetic pregnancies: policy decisions in practice. Diabet Med. 1999 Jul;16(7):573-8. doi: 10.1046/j.1464-5491.1999.00124.x.
- Results publication: PubMed 17126946Kline GA, Edwards A. Antepartum and intra-partum insulin management of type 1 and type 2 diabetic women: Impact on clinically significant neonatal hypoglycemia. Diabetes Res Clin Pract. 2007 Aug;77(2):223-30. doi: 10.1016/j.diabres.2006.10.024. Epub 2006 Nov 28.
- Results publication: PubMed 2137758Lean ME, Pearson DW, Sutherland HW. Insulin management during labour and delivery in mothers with diabetes. Diabet Med. 1990 Feb;7(2):162-4. doi: 10.1111/j.1464-5491.1990.tb01352.x.
- Results publication: PubMed 11105967Balsells M, Corcoy R, Adelantado JM, Garcia-Patterson A, Altirriba O, de Leiva A. Gestational diabetes mellitus: metabolic control during labour. Diabetes Nutr Metab. 2000 Oct;13(5):257-62.
- Individual participant dataSharing planned: Undecided
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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.
Gali Gali, MD principal investigator
HaEmemk Medical Center, Afula, Israel.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing glucose solution and Insulin and glucose solution only in people with Obstetric Labor and Pregnancy in Diabetics, run by HaEmek Medical Center, Israel at 1 site in Israel.
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 3 inclusion and 4 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 11 Oct 2023. 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 Israel. 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.
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 Gali Gali, MD (972-4-6494035, galit_ga@clalit.org.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Neonatal hypoglycemia (time frame: 2-3 hours postpartum). 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 NCT03273881, which also lists 15 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 11 Oct 2023.