Type II Diabetes MellitusNCT03912363
Intrapartum Glycemic Control With Insulin Infusion Versus Rotating Fluids
A study testing Rotating fluids protocol and Insulin infusion protocol in people with Type II Diabetes Mellitus and Gestational Diabetes Mellitus, run by Geisinger Clinic at 2 sites in United States.
Trial summary
This study will determine whether rotating intravenous (IV) fluid is better than receiving insulin to control a baby's blood sugar after delivery in laboring women with diabetes. A computer will choose the method of controlling the participant's blood sugar while they are in labor. Read more about this study
- Who is it for?
- Ages 14 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Type II Diabetes Mellitus, Gestational Diabetes Mellitus
- What is being tested?
- Rotating fluids protocol and Insulin infusion protocol
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 114 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Nov 2019to 1 Mar 2025
- 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 14 to 50 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Pregnant women with Type II diabetes mellitus or GDM controlled with insulin and/or hypoglycemic medication (GDMA2)
- Singleton pregnancies
- Gestational age between 37 0/7 weeks and 40 0/7 weeks
- Planned delivery at a Geisinger Medical Center (GMC) or Geisinger Wyoming Valley (GWV)
- English or Spanish speaking
- Anticipated delivery at ≥ 4 hours from randomization (e.g., cervical dilation at ≤ 7 cm at time of randomization)
Who cannot join
- Women with Type 1 diabetes mellitus or use of insulin pump
- Evidence of diabetic ketoacidosis at time of admission for delivery
- Multifetal gestation
- Gestational age < 37 0/7 weeks or > 40 0/7 weeks
- Non-English or Non-Spanish speaking
- Anticipated delivery < 4 hours from randomization (e.g., cervical dilation > 7 cm at time of randomization, first cesarean delivery of the day)
Show all 12Show fewer
- Oral corticosteroid use within 48 hours of planned delivery
- Antenatal corticosteroid use within 7 days of admission for delivery
- Delivery planned outside of GMC or GWV
- Fetal demise
- Prenatal diagnosis of lethal fetal anomaly
- Active infection or immunocompromised state (e.g., HIV/AIDS, active malignancy, use of immunosuppressant medication) at time of admission for delivery
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Geisinger
Danville, Pennsylvania, 17822
Geisinger Wyoming Valley
Wilkes-Barre, Pennsylvania, 18711
About this study
Official title: Intrapartum Glycemic Control With Insulin Infusion Versus Rotating Fluids: Randomized Controlled Trial (RCT)
This study will determine whether rotating intravenous (IV) fluid is better than receiving insulin to control a baby's blood sugar after delivery in laboring women with diabetes. A computer will choose the method of controlling the participant's blood sugar while they are in labor.
Read the detailed description
Diabetes complicates 6-9% of all pregnancies. Of those pregnancies, 90% of pregnant diabetics have gestational diabetes mellitus (GDM), while the remainder of patients have pre-existing diabetes mellitus (DM). Maternal hyperglycemia has a negative impact on maternal and fetal/neonatal health. Adverse neonatal outcomes include birth injuries, respiratory distress, and metabolic derangements such as hypoglycemia. The incidence of neonatal hypoglycemia is higher in pregnancies complicated by pre-existing DM (24-48%) when compared to patients with GDM (16-19%).
Neonatal hypoglycemia causes immediate and long-term morbidity. Treatment of hypoglycemia may require admission to the Neonatal Intensive Care Unit (NICU). The severity and duration of neonatal hypoglycemia raises concern for permanent neurologic damage to the neonate. Even transient episodes of neonatal hypoglycemia have been associated with neurodevelopmental impairment. It is imperative that measures be taken in diabetic mothers (both pre-existing and gestational) to minimize the risk of neonatal hypoglycemia. While antepartum maternal glucose control remains an important factor in preventing neonatal complications, prevention of maternal hyperglycemia during the intrapartum period has been shown to reduce the risk of neonatal hypoglycemia.
Therapies utilized for maternal intrapartum glycemic control across academic centers in the United States include the use of insulin and rotation of intravenous (IV) fluids. Although used in clinical practice for intrapartum glycemic control, the impact of rotating IV fluids on neonatal blood glucose is unknown. The potential for using rotating IV fluids to control intrapartum blood glucose has several advantages over using insulin for optimization of blood glucose. There is minimal risk of maternal hypoglycemia using IV fluids when compared to insulin therapy. There is also less risk of medication error. IV fluids are easily administered as they do not require separate peripheral access and are easily accessible on a Labor and Delivery (L\&D) unit.
The investigators propose a randomized controlled trial (RCT) to assess the effect of maternal intrapartum glycemic control with rotating IV fluids compared to insulin infusion on neonatal blood glucose levels within two hours of birth. The investigators hypothesize neonates born to mothers managed by rotating fluids will have higher neonatal blood glucose levels (closer to normal range) within two hours of birth compared to neonates born to mothers managed by insulin infusion.
- Being tested
- Rotating fluids protocol, Insulin infusion protocol
- Keywords
- intrapartum, glycemic control, diabetes, insulin
- Medical subject headings
- Diabetes Mellitus, Type 2, Diabetes, Gestational, Diabetes Mellitus, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rotating fluids protocolOther
IV fluids at a rate of 100-150 ml/hr will be administered:
- For blood glucose < 100 mg/dL or less: IV fluids with 5% dextrose
- For blood glucose between 101-140 mg/dL: IV fluids without 5% dextrose
- For blood glucose > 140 mg/dL on two consecutive occasions: insulin infusion protocol (Study arm 2)
Insulin infusion protocolOther
Regular insulin at 1 unit/ml AND IV fluids at a rate of 100-150 ml/hr will be administered:
- For blood glucose < 80 mg/dL: No insulin AND IV fluids with 5% dextrose
- For blood glucose 80-100 mg/dL: Insulin at 0.5 U/hr AND IV fluids with 5% dextrose
- For blood glucose 101-140 mg/dL: Insulin at 1.0 U/hr AND IV fluids with 5% dextrose
- For blood glucose 141-180 mg/dL: Insulin at 1.5 U/hr AND IV fluids with 5% dextrose
- For blood glucose 181-220 mg/dL: Insulin at 2.0 U/hr AND IV fluid without dextrose
- For blood glucose > 220 mg/dL: Insulin at 2.5 U/hr AND IV fluids without dextrose
| Study group | Role | What they receive |
|---|---|---|
| Rotating fluids | Active comparator | Rotating fluids protocol will be initiated at the time of admission to Labor and Delivery. Receives: Other: Rotating fluids protocol |
| Insulin infusion | Active comparator | Insulin infusion protocol will be initiated at the time of admission to Labor and Delivery. Receives: Other: Insulin infusion protocol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neonatal blood glucose value
Neonatal blood glucose value from birth to 2 hours of life
Measured: Within 2 hours of life
Secondary outcomes (5)
Mean neonatal blood glucose value
Average of neonatal blood glucose values from birth to 24 hours of life
Measured: First 24 hours of life
Incidence of maternal hypoglycemia
Blood glucose value < 50 mg/dL without symptoms OR Blood glucose value < 70 mg/dL with symptoms such as perspiration, palpitations, tremor, weakness, anxiety
Measured: During labor (average time 24 hours)
Mean intrapartum maternal blood glucose value
Average of maternal blood glucose values during labor
Measured: During labor (average time 24 hours)
Maternal blood glucose value before delivery
Blood glucose value
Measured: Within one hour of delivery
Incidence of composite neonatal outcome
Neonatal hypoglycemia, NICU admission, neonatal hyperbilirubinemia, and neonatal respiratory distress syndrome
Measured: First 24 hours of life until discharge (average time 21 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2019
- Study start1 Nov 2019
- Primary completion30 May 2024
- Study completion1 Mar 2025
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 Type II Diabetes MellitusStudies 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
- Model description
- Randomized controlled trial
- Masking
- None (open label)
- Enrolment
- 114 participants (actual)
Sponsor and investigators
- Lead sponsor
- Geisinger Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michael J Paglia, MD, PhD, Principal investigator, Geisinger Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03912363
- Sponsor's protocol ID
- 2018-0502
- Status last verified
- Jun 2025
- First submitted
- 9 Apr 2019
- Last updated
- 12 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
DeSisto CL, Kim SY, Sharma AJ. Prevalence estimates of gestational diabetes mellitus in the United States, Pregnancy Risk Assessment Monitoring System (PRAMS), 2007-2010. Prev Chronic Dis. 2014 Jun 19;11:E104. doi: 10.5888/pcd11.130415.
PubMed 24945238American 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 30461693HAPO 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 18463375Rosenberg VA, Eglinton GS, Rauch ER, Skupski DW. Intrapartum maternal glycemic control in women with insulin requiring diabetes: a randomized clinical trial of rotating fluids versus insulin drip. Am J Obstet Gynecol. 2006 Oct;195(4):1095-9. doi: 10.1016/j.ajog.2006.05.051. Epub 2006 Aug 8.
PubMed 16893507Golde SH, Good-Anderson B, Montoro M, Artal R. Insulin requirements during labor: a reappraisal. Am J Obstet Gynecol. 1982 Nov 1;144(5):556-9. doi: 10.1016/0002-9378(82)90227-7.
PubMed 6753588
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intrapartum Glycemic Control With Insulin Infusion Versus Rotating Fluids: Randomized Controlled Trial (RCT)
- ClinicalTrials.gov ID
- NCT03912363
- Acronym / sponsor ID
- 2018-0502
- Keywords
- intrapartum, glycemic control, diabetes, insulin
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 114 participants (actual)
- Lead sponsor
- Geisinger ClinicUniversity, hospital or other
- Study start
- 1 Nov 2019 (actual)
- Primary completion
- 30 May 2024 (actual)
- Study completion
- 1 Mar 2025 (actual)
- First posted
- 11 Apr 2019 (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 will determine whether rotating intravenous (IV) fluid is better than receiving insulin to control a baby's blood sugar after delivery in laboring women with diabetes. A computer will choose the method of controlling the participant's blood sugar while they are in labor.
Detailed description
Diabetes complicates 6-9% of all pregnancies. Of those pregnancies, 90% of pregnant diabetics have gestational diabetes mellitus (GDM), while the remainder of patients have pre-existing diabetes mellitus (DM). Maternal hyperglycemia has a negative impact on maternal and fetal/neonatal health. Adverse neonatal outcomes include birth injuries, respiratory distress, and metabolic derangements such as hypoglycemia. The incidence of neonatal hypoglycemia is higher in pregnancies complicated by pre-existing DM (24-48%) when compared to patients with GDM (16-19%).
Neonatal hypoglycemia causes immediate and long-term morbidity. Treatment of hypoglycemia may require admission to the Neonatal Intensive Care Unit (NICU). The severity and duration of neonatal hypoglycemia raises concern for permanent neurologic damage to the neonate. Even transient episodes of neonatal hypoglycemia have been associated with neurodevelopmental impairment. It is imperative that measures be taken in diabetic mothers (both pre-existing and gestational) to minimize the risk of neonatal hypoglycemia. While antepartum maternal glucose control remains an important factor in preventing neonatal complications, prevention of maternal hyperglycemia during the intrapartum period has been shown to reduce the risk of neonatal hypoglycemia.
Therapies utilized for maternal intrapartum glycemic control across academic centers in the United States include the use of insulin and rotation of intravenous (IV) fluids. Although used in clinical practice for intrapartum glycemic control, the impact of rotating IV fluids on neonatal blood glucose is unknown. The potential for using rotating IV fluids to control intrapartum blood glucose has several advantages over using insulin for optimization of blood glucose. There is minimal risk of maternal hypoglycemia using IV fluids when compared to insulin therapy. There is also less risk of medication error. IV fluids are easily administered as they do not require separate peripheral access and are easily accessible on a Labor and Delivery (L\&D) unit.
The investigators propose a randomized controlled trial (RCT) to assess the effect of maternal intrapartum glycemic control with rotating IV fluids compared to insulin infusion on neonatal blood glucose levels within two hours of birth. The investigators hypothesize neonates born to mothers managed by rotating fluids will have higher neonatal blood glucose levels (closer to normal range) within two hours of birth compared to neonates born to mothers managed by insulin infusion.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Rotating fluids | Active comparator | Other: Rotating fluids protocolRotating fluids protocol will be initiated at the time of admission to Labor and Delivery. |
| Insulin infusion | Active comparator | Other: Insulin infusion protocolInsulin infusion protocol will be initiated at the time of admission to Labor and Delivery. |
Who may qualify
- Ages
- 14 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- Pregnant women with Type II diabetes mellitus or GDM controlled with insulin and/or hypoglycemic medication (GDMA2)
- Singleton pregnancies
- Gestational age between 37 0/7 weeks and 40 0/7 weeks
- Planned delivery at a Geisinger Medical Center (GMC) or Geisinger Wyoming Valley (GWV)
- English or Spanish speaking
Key exclusion criteria (12 listed)
- Women with Type 1 diabetes mellitus or use of insulin pump
- Evidence of diabetic ketoacidosis at time of admission for delivery
- Multifetal gestation
- Gestational age < 37 0/7 weeks or > 40 0/7 weeks
- Non-English or Non-Spanish speaking
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 |
|---|---|---|
| Rotating fluids protocolIV fluids at a rate of 100-150 ml/hr will be administered: * For blood glucose < 100 mg/dL or less: IV fluids with 5% dextrose * For blood glucose between 101-140 mg/dL: IV fluids without 5% dextrose * For blood glucose > 140 mg/dL on two consecutive occasions: insulin infusion protocol (Study arm 2) | Other | Rotating fluids |
| Insulin infusion protocolRegular insulin at 1 unit/ml AND IV fluids at a rate of 100-150 ml/hr will be administered: * For blood glucose < 80 mg/dL: No insulin AND IV fluids with 5% dextrose * For blood glucose 80-100 mg/dL: Insulin at 0.5 U/hr AND IV fluids with 5% dextrose * For blood glucose 101-140 mg/dL: Insulin at 1.0 U/hr AND IV fluids with 5% dextrose * For blood glucose 141-180 mg/dL: Insulin at 1.5 U/hr AND IV fluids with 5% dextrose * For blood glucose 181-220 mg/dL: Insulin at 2.0 U/hr AND IV fluid without dextrose * For blood glucose > 220 mg/dL: Insulin at 2.5 U/hr AND IV fluids without dextrose | Other | Insulin infusion |
Primary outcome
Neonatal blood glucose value
Time frame: Within 2 hours of life
Neonatal blood glucose value from birth to 2 hours of life
5 secondary outcomes
Mean neonatal blood glucose value
Time frame: First 24 hours of life
Incidence of maternal hypoglycemia
Time frame: During labor (average time 24 hours)
Mean intrapartum maternal blood glucose value
Time frame: During labor (average time 24 hours)
Maternal blood glucose value before delivery
Time frame: Within one hour of delivery
Incidence of composite neonatal outcome
Time frame: First 24 hours of life until discharge (average time 21 days)
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 12 Jun 2025.
- Background: PubMed 24945238DeSisto CL, Kim SY, Sharma AJ. Prevalence estimates of gestational diabetes mellitus in the United States, Pregnancy Risk Assessment Monitoring System (PRAMS), 2007-2010. Prev Chronic Dis. 2014 Jun 19;11:E104. doi: 10.5888/pcd11.130415.
- 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 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 16893507Rosenberg VA, Eglinton GS, Rauch ER, Skupski DW. Intrapartum maternal glycemic control in women with insulin requiring diabetes: a randomized clinical trial of rotating fluids versus insulin drip. Am J Obstet Gynecol. 2006 Oct;195(4):1095-9. doi: 10.1016/j.ajog.2006.05.051. Epub 2006 Aug 8.
- Background: PubMed 6753588Golde SH, Good-Anderson B, Montoro M, Artal R. Insulin requirements during labor: a reappraisal. Am J Obstet Gynecol. 1982 Nov 1;144(5):556-9. doi: 10.1016/0002-9378(82)90227-7.
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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.
Michael J Paglia, MD, PhD principal investigator
Geisinger Clinic
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Rotating fluids protocol and Insulin infusion protocol in people with Type II Diabetes Mellitus and Gestational Diabetes Mellitus, run by Geisinger Clinic at 2 sites 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 6 inclusion and 12 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 12 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Neonatal blood glucose value (time frame: Within 2 hours of life). 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 NCT03912363, 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 12 Jun 2025.