Gestational Diabetes Mellitus in PregnancyNCT06643351
Intrapartum Glucose Control and Risk of Neonatal Hypoglycemia
A study testing Standard Intrapartum Glucose Target Range and Liberalized Intrapartum Glucose Target Range in people with Gestational Diabetes Mellitus in Pregnancy and Pregestational Diabetes Mellitus, run by University of Pittsburgh at 1 site in United States.
Trial summary
The purpose of this study is to assess whether a liberal intrapartum glycemic target range compared to usual care standard control ranges will lead to a decrease in the rate of neonatal hypoglycemia among pregnant patients in labor with diabetes. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Gestational Diabetes Mellitus in Pregnancy, Pregestational Diabetes Mellitus, Neonatal Hypoglycemia
- What is being tested?
- Standard Intrapartum Glucose Target Range and Liberalized Intrapartum Glucose Target Range
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 169 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Dec 2024to 31 Jul 2026
- 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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Pregnant patients with Pre-gestational (Type 1 or Type 2) or Gestational Diabetes
- Singleton Gestations
- Greater than or equal to 35 weeks gestation
- Planned for vaginal delivery at the University of Pittsburgh Medical Center Magee-Womens Hospital (UPMC MWH)
Who cannot join
- Major fetal anomalies anticipated to require NICU admission
- Planned Cesarean delivery
Trial locations and contacts
1 site in 1 country.
United States1 site
Magee-Women's Hospital of UPMC
Pittsburgh, Pennsylvania, 15213
About this study
Official title: Intrapartum Maternal Glucose Control and Effect on Neonatal Hypoglycemia
The purpose of this study is to assess whether a liberal intrapartum glycemic target range compared to usual care standard control ranges will lead to a decrease in the rate of neonatal hypoglycemia among pregnant patients in labor with diabetes.
Read the detailed description
Neonatal hypoglycemia is a leading cause of admission to the neonatal ICU (NICU) and is associated with increased costs, separation from mothers, and when severe, long term neurological sequelae. Prior research has suggested an association between intrapartum maternal glucose and the risk of neonatal hypoglycemia, so current insulin administration protocols aimed to maintain the blood glucose close to 100mg/dl.
However, recent studies have found inconsistent evidence of a relationship between intrapartum maternal glucose and neonatal hypoglycemia, Furthermore, on review of previously established protocols, improved maternal glucose control came with an increased frequency of neonatal hypoglycemia. Thus, these findings have suggested that relaxing the intrapartum goals for maternal glucose may be associated with improved neonatal outcomes.
Few randomized controlled trials (RCTs) exist in evaluating neonatal outcomes comparing liberal versus tight intrapartum glycemic control. Recent RCTs have found that tight maternal glucose control in labor was associated with lower mean neonatal blood glucose levels in the first 24 hours of life. While another recent RCT found that a permissive blood glucose (up to 180mg/dl) threshold was associated with equivalent neonatal blood glucose levels when compared to the standard, strict thresholds (up to 110mg/dl).
In this study, participants will be recruited at delivery planning outpatient visits or at admission to labor and delivery and stratified by type of diabetes into two groups, either Type 1 Diabetes or Gestational Diabetes(GDM)/Type 2 diabetes. They will then be randomized to one of two intervention groups. The liberalized treatment group will have a target Glucose Range 70 - 160mg/dl and receive treatment via insulin drip will be initiated if the blood sugar exceeds the upper bound. The standard treatment Group will have a glucose target Glucose Range 70 - 110mg/dl and receive treatment via insulin drip will be initiated if the blood sugar exceeds the upper bound.
The specific aim of this project is to determine the effectiveness of liberalized intrapartum glycemic targets in reducing the incidence of neonatal hypoglycemia.
- Conditions
- Gestational Diabetes Mellitus in Pregnancy, Pregestational Diabetes Mellitus, Neonatal Hypoglycemia
- Being tested
- Standard Intrapartum Glucose Target Range, Liberalized Intrapartum Glucose Target Range
- Keywords
- Gestational Diabetes, Pregestational Diabetes, Neonatal Hypoglycemia, Intrapartum Glucose
- Medical subject headings
- Diabetes, Gestational
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard Intrapartum Glucose Target RangeOther
Intrapartum maternal glucose management involves frequent blood sugar checks and the use of insulin intravenous drip as needed. Maternal capillary blood sugar is checked every 4 hours in early labor, 2 hours in active labor and hourly during the second stage of labor. The frequency of maternal glucose monitoring will not differ by study group. The goal intrapartum glucose target range will be 70-110mg/dl. Insulin infusion will be initiated when maternal capillary glucose exceeds 110 mg/dL. Once an insulin infusion is initiated, glucose monitoring frequency will occur by protocol. A hypoglycemia protocol is initiated if the maternal blood sugar is less than 60mg/dl.
Liberalized Intrapartum Glucose Target RangeOther
Intrapartum maternal glucose management involves frequent blood sugar checks and the use of insulin intravenous drip as needed. Maternal capillary blood sugar is checked every 4 hours in early labor, 2 hours in active labor and hourly during the second stage of labor. The frequency of maternal glucose monitoring will not differ by study group. The goal intrapartum glucose target range will be 70-160mg/dl. Insulin infusion will be initiated when maternal capillary glucose exceeds 160 mg/dL. Once an insulin infusion is initiated, glucose monitoring frequency will occur by protocol. A hypoglycemia protocol is initiated if the maternal blood sugar is less than 60mg/dl.
| Study group | Role | What they receive |
|---|---|---|
| Standard Intrapartum Glucose Target Range | Active comparator | The goal intrapartum glucose target range will be 70-110mg/dl. Insulin infusion will be initiated when maternal capillary glucose exceeds 110 mg/dL. Receives: Other: Standard Intrapartum Glucose Target Range |
| Liberalized Intrapartum Glucose Target Range | Experimental | The goal intrapartum glucose target range will be 70-160mg/dl. Insulin infusion will be initiated when maternal capillary glucose exceeds 160 mg/dL. Receives: Other: Liberalized Intrapartum Glucose Target Range |
What is being measured
The primary outcome is the main question the study is designed to answer.
Immediate postnatal Neonatal hypoglycemia
Number of newborns with neonatal hypoglycemia, defined as a blood glucose of less than 45mg/dL
Measured: Within the first 24 hours after delivery.
Secondary outcomes (7)
Any neonatal hypoglycemia
Number of newborns with neonatal hypoglycemia, defined as a blood glucose of less than 45mg/dL
Measured: Prior to neonatal discharge, up to 42 days after delivery.
Mean neonatal blood glucose
Measured in mg/dL
Measured: Prior to neonatal discharge, up to 42 days after delivery.
Neonatal Hypoglycemia Requiring IV Treatment
number of newborns with hypoglycemia that requires IV treatment
Measured: Prior to neonatal discharge, up to 42 days after delivery.
NICU admission
Number of NICU admission for any indication.
Measured: Prior to discharge, up to 42 days after delivery.
Maternal Intrapartum Hyperglycemia
Number of participants that have hyperglycemia episodes. Hyperglycemia is defined as blood sugar levels greater than 180 mg/dl
Measured: During labor( for up to 200 hours)
Maternal intrapartum hypoglycemia
Number of participants that have hypoglycemia episodes. Hyp0glycemia is defined as blood sugar levels less than 60 mg/dl
Measured: During labor( for up to 200 hours)
Mean maternal intrapartum blood glucose
Overall mean maternal glucose values in mg/dl
Measured: During labor( for up to 200 hours)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2024
- Study start3 Dec 2024
- Primary completion1 May 2026
- Study completion31 Jul 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Gestational Diabetes Mellitus in PregnancyStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 169 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Praveen Ramesh, University of Pittsburgh
- Investigators
- Praveen Ramesh, M.D., Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06643351
- Sponsor's protocol ID
- STUDY24050197
- Status last verified
- Aug 2026
- First submitted
- 12 Oct 2024
- Last updated
- 14 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is currently no plan to make individual participant data available to other researchers. The findings are anticipated to be reported in standard specialty journals.
Publications
Dude AM, Niznik C, Peaceman AM, Yee LM. Evaluation of an Intrapartum Insulin Regimen for Women With Diabetes. Obstet Gynecol. 2020 Aug;136(2):411-416. doi: 10.1097/AOG.0000000000003940.
PubMed 32649492Yamamoto JM, Benham J, Mohammad K, Donovan LE, Wood S. Intrapartum glycaemic control and neonatal hypoglycaemia in pregnancies complicated by diabetes: a systematic review. Diabet Med. 2018 Feb;35(2):173-183. doi: 10.1111/dme.13546.
PubMed 29117445American College of Obstetricians and Gynecologists' Committee on Practice Bulletins-Obstetrics. ACOG Practice Bulletin No. 201: Pregestational Diabetes Mellitus. Obstet Gynecol. 2018 Dec;132(6):e228-e248. doi: 10.1097/AOG.0000000000002960.
PubMed 30461693Dude A, Niznik CM, Szmuilowicz ED, Peaceman AM, Yee LM. Management of Diabetes in the Intrapartum and Postpartum Patient. Am J Perinatol. 2018 Sep;35(11):1119-1126. doi: 10.1055/s-0038-1629903. Epub 2018 Mar 13.
PubMed 29534258Burns CM, Rutherford MA, Boardman JP, Cowan FM. Patterns of cerebral injury and neurodevelopmental outcomes after symptomatic neonatal hypoglycemia. Pediatrics. 2008 Jul;122(1):65-74. doi: 10.1542/peds.2007-2822.
PubMed 18595988
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intrapartum Maternal Glucose Control and Effect on Neonatal Hypoglycemia
- ClinicalTrials.gov ID
- NCT06643351
- Acronym / sponsor ID
- STUDY24050197
- Conditions
- Gestational Diabetes Mellitus in Pregnancy, Pregestational Diabetes Mellitus, Neonatal Hypoglycemia
- Keywords
- Gestational Diabetes, Pregestational Diabetes, Neonatal Hypoglycemia, Intrapartum Glucose
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 169 participants (actual)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Study start
- 3 Dec 2024 (actual)
- Primary completion
- 1 May 2026 (actual)
- Study completion
- 31 Jul 2026 (actual)
- First posted
- 16 Oct 2024 (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.
The purpose of this study is to assess whether a liberal intrapartum glycemic target range compared to usual care standard control ranges will lead to a decrease in the rate of neonatal hypoglycemia among pregnant patients in labor with diabetes.
Detailed description
Neonatal hypoglycemia is a leading cause of admission to the neonatal ICU (NICU) and is associated with increased costs, separation from mothers, and when severe, long term neurological sequelae. Prior research has suggested an association between intrapartum maternal glucose and the risk of neonatal hypoglycemia, so current insulin administration protocols aimed to maintain the blood glucose close to 100mg/dl.
However, recent studies have found inconsistent evidence of a relationship between intrapartum maternal glucose and neonatal hypoglycemia, Furthermore, on review of previously established protocols, improved maternal glucose control came with an increased frequency of neonatal hypoglycemia. Thus, these findings have suggested that relaxing the intrapartum goals for maternal glucose may be associated with improved neonatal outcomes.
Few randomized controlled trials (RCTs) exist in evaluating neonatal outcomes comparing liberal versus tight intrapartum glycemic control. Recent RCTs have found that tight maternal glucose control in labor was associated with lower mean neonatal blood glucose levels in the first 24 hours of life. While another recent RCT found that a permissive blood glucose (up to 180mg/dl) threshold was associated with equivalent neonatal blood glucose levels when compared to the standard, strict thresholds (up to 110mg/dl).
In this study, participants will be recruited at delivery planning outpatient visits or at admission to labor and delivery and stratified by type of diabetes into two groups, either Type 1 Diabetes or Gestational Diabetes(GDM)/Type 2 diabetes. They will then be randomized to one of two intervention groups. The liberalized treatment group will have a target Glucose Range 70 - 160mg/dl and receive treatment via insulin drip will be initiated if the blood sugar exceeds the upper bound. The standard treatment Group will have a glucose target Glucose Range 70 - 110mg/dl and receive treatment via insulin drip will be initiated if the blood sugar exceeds the upper bound.
The specific aim of this project is to determine the effectiveness of liberalized intrapartum glycemic targets in reducing the incidence of neonatal hypoglycemia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard Intrapartum Glucose Target Range | Active comparator | Other: Standard Intrapartum Glucose Target RangeThe goal intrapartum glucose target range will be 70-110mg/dl. Insulin infusion will be initiated when maternal capillary glucose exceeds 110 mg/dL. |
| Liberalized Intrapartum Glucose Target Range | Experimental | Other: Liberalized Intrapartum Glucose Target RangeThe goal intrapartum glucose target range will be 70-160mg/dl. Insulin infusion will be initiated when maternal capillary glucose exceeds 160 mg/dL. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Pregnant patients with Pre-gestational (Type 1 or Type 2) or Gestational Diabetes
- Singleton Gestations
- Greater than or equal to 35 weeks gestation
- Planned for vaginal delivery at the University of Pittsburgh Medical Center Magee-Womens Hospital (UPMC MWH)
Key exclusion criteria (2 listed)
- Major fetal anomalies anticipated to require NICU admission
- Planned Cesarean delivery
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 |
|---|---|---|
| Standard Intrapartum Glucose Target RangeIntrapartum maternal glucose management involves frequent blood sugar checks and the use of insulin intravenous drip as needed. Maternal capillary blood sugar is checked every 4 hours in early labor, 2 hours in active labor and hourly during the second stage of labor. The frequency of maternal glucose monitoring will not differ by study group. The goal intrapartum glucose target range will be 70-110mg/dl. Insulin infusion will be initiated when maternal capillary glucose exceeds 110 mg/dL. Once an insulin infusion is initiated, glucose monitoring frequency will occur by protocol. A hypoglycemia protocol is initiated if the maternal blood sugar is less than 60mg/dl. | Other | Standard Intrapartum Glucose Target Range |
| Liberalized Intrapartum Glucose Target RangeIntrapartum maternal glucose management involves frequent blood sugar checks and the use of insulin intravenous drip as needed. Maternal capillary blood sugar is checked every 4 hours in early labor, 2 hours in active labor and hourly during the second stage of labor. The frequency of maternal glucose monitoring will not differ by study group. The goal intrapartum glucose target range will be 70-160mg/dl. Insulin infusion will be initiated when maternal capillary glucose exceeds 160 mg/dL. Once an insulin infusion is initiated, glucose monitoring frequency will occur by protocol. A hypoglycemia protocol is initiated if the maternal blood sugar is less than 60mg/dl. | Other | Liberalized Intrapartum Glucose Target Range |
Primary outcome
Immediate postnatal Neonatal hypoglycemia
Time frame: Within the first 24 hours after delivery.
Number of newborns with neonatal hypoglycemia, defined as a blood glucose of less than 45mg/dL
7 secondary outcomes
Any neonatal hypoglycemia
Time frame: Prior to neonatal discharge, up to 42 days after delivery.
Mean neonatal blood glucose
Time frame: Prior to neonatal discharge, up to 42 days after delivery.
Neonatal Hypoglycemia Requiring IV Treatment
Time frame: Prior to neonatal discharge, up to 42 days after delivery.
NICU admission
Time frame: Prior to discharge, up to 42 days after delivery.
Maternal Intrapartum Hyperglycemia
Time frame: During labor( for up to 200 hours)
Maternal intrapartum hypoglycemia
Time frame: During labor( for up to 200 hours)
Mean maternal intrapartum blood glucose
Time frame: During labor( for up to 200 hours)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2026.
- Background: PubMed 32649492Dude AM, Niznik C, Peaceman AM, Yee LM. Evaluation of an Intrapartum Insulin Regimen for Women With Diabetes. Obstet Gynecol. 2020 Aug;136(2):411-416. doi: 10.1097/AOG.0000000000003940.
- Background: PubMed 29117445Yamamoto JM, Benham J, Mohammad K, Donovan LE, Wood S. Intrapartum glycaemic control and neonatal hypoglycaemia in pregnancies complicated by diabetes: a systematic review. Diabet Med. 2018 Feb;35(2):173-183. doi: 10.1111/dme.13546.
- Background: PubMed 30461693American College of Obstetricians and Gynecologists' Committee on Practice Bulletins-Obstetrics. ACOG Practice Bulletin No. 201: Pregestational Diabetes Mellitus. Obstet Gynecol. 2018 Dec;132(6):e228-e248. doi: 10.1097/AOG.0000000000002960.
- Background: PubMed 29534258Dude A, Niznik CM, Szmuilowicz ED, Peaceman AM, Yee LM. Management of Diabetes in the Intrapartum and Postpartum Patient. Am J Perinatol. 2018 Sep;35(11):1119-1126. doi: 10.1055/s-0038-1629903. Epub 2018 Mar 13.
- Background: PubMed 18595988Burns CM, Rutherford MA, Boardman JP, Cowan FM. Patterns of cerebral injury and neurodevelopmental outcomes after symptomatic neonatal hypoglycemia. Pediatrics. 2008 Jul;122(1):65-74. doi: 10.1542/peds.2007-2822.
- Individual participant dataSharing planned: No. There is currently no plan to make individual participant data available to other researchers. The findings are anticipated to be reported in standard specialty journals.
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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.
Praveen Ramesh, M.D. principal investigator
University of Pittsburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standard Intrapartum Glucose Target Range and Liberalized Intrapartum Glucose Target Range in people with Gestational Diabetes Mellitus in Pregnancy and Pregestational Diabetes Mellitus, run by University of Pittsburgh at 1 site in United States.
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 4 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: finished, as of the sponsor's last update on 14 Aug 2026. 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 United States. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Immediate postnatal Neonatal hypoglycemia (time frame: Within the first 24 hours after delivery.). 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 NCT06643351, which also lists 5 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 14 Aug 2026.