Gestational DiabetesNCT05553275
Permissive Intrapartum Glucose Control
A study of Gestational Diabetes and Pregestational Diabetes, run by The University of Texas Health Science Center, Houston at 1 site in United States.
Trial summary
The purpose of this study is to assess whether permissive intrapartum glycemic control compared to usual care would lead to similar rate of neonatal hypoglycemia among people with diabetes. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Gestational Diabetes, Pregestational Diabetes
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Oct 2022to 13 Aug 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Singleton gestation
- Presenting for intrapartum management (induction, labor, augmentation)
- Any diagnosis of Type 1 Diabetes Mellitus(T1DM), Type 2 Diabetes Mellitus (T2DM), or Gestational Diabetes
- English or Spanish fluency
Who cannot join
- Major fetal anomalies affecting glucose metabolism
- Multiple Gestation
- Incarcerated subjects
- less than 34 weeks gestation of pregnancy
- Planned cesarean delivery
- Utilizing insulin pump during labor
- Stillbirth
- Presenting in Diabetic ketoacidosis(DKA)
Trial locations and contacts
1 site in 1 country.
United States1 site
The University of Texas Health Science Center at Houston
Houston, Texas, 77030
About this study
Official title: Permissive Intrapartum Glucose Control: An Equivalence Randomized Control Study (PERMIT)
The purpose of this study is to assess whether permissive intrapartum glycemic control compared to usual care would lead to similar rate of neonatal hypoglycemia among people with diabetes.
- Conditions
- Gestational Diabetes, Pregestational Diabetes
- Being tested
- Usual Care, Permissive intrapartum glucose control
- Keywords
- Diabetes Mellitus
- Medical subject headings
- Diabetes, Gestational, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Usual CareProcedure or surgery
Blood sugar evaluation (accuchecks) every four hours in latent labor and every 2 hours in active labor.Participants will be routinely managed with maintenance fluids of lactated ringers during latent labor and lactated ringers with dextrose 5% in active labor. Blood sugars of more than 110 mg/dl at any time point in labor will be treated with an insulin drip as follows:
Regular insulin (100 units) in 100cc of normal saline, with Lactated Ringers with 5% dextrose at 125cc/hour. If blood sugar 111-140, insulin drip at 1 unit/hour will be given and continued if blood sugar is 111-140.If blood sugar is 141-180, then drip will be changed to to 1.5 unit/hour and if blood sugar is 181-220, drip will be changed to 2.0 units/hour and MD will be called if blood sugar is more than 221 mg/dl
Permissive intrapartum glucose controlProcedure or surgery
Blood sugar evaluation (accuchecks) every four hours in latent labor and every 2 hours in active labor.Participants will be routinely management with maintenance fluids of lactated ringers during latent labor and lactated ringers with dextrose 5% in active labor.Blood sugars of more than 180 mg/dl at any time point in labor will be treated with an insulin drip as follows:
Regular insulin (100 units) in 100cc of normal saline, with Lactated Ringers with 5% dextrose at 125cc/hour.If blood sugar is 181-200, insulin drip at 1 unit/hour will be given. If blood sugar is 201-220, then drip will be changed to 1.5 units/hour. If blood sugar is 221 - 250, then drip will be changed to 2.0 units/hour and if blood sugar is more than 251 MD will be called.
| Study group | Role | What they receive |
|---|---|---|
| Group 1:Usual Care | Active comparator | Not described Receives: Procedure: Usual Care |
| Group 2: Permissive Care | Experimental | Not described Receives: Procedure: Permissive intrapartum glucose control |
What is being measured
The primary outcome is the main question the study is designed to answer.
first neonatal blood glucose level measured in mg/dL
Measured: up to 2 hours of life prior to first feed
Secondary outcomes (44)
Number of intrapartum glucose measurements
Measured: During Labor(for up to 200 hours)
Mean maternal glucose values in mg/dl
Measured: during latent labor(for up to 200 hours)
Mean maternal glucose values in mg/dl
Measured: during active labor(for up to 200 hours)
Overall mean maternal glucose values in mg/dl
Measured: in all of labor(for up to 200 hours)
Number of participants that have hyperglycemia episodes
Hyperglycemia is defined as blood sugar levels greater than 200 mg/dl
Measured: during labor( for up to 200 hours)
Number of participants that have hypoglycemia episodes
Hypoglycemia is defined as blood sugar levels less than or equal to 60 mg/dl or symptomatic or requiring IV dextrose
Measured: during labor(for up to 200 hours)
Number of participants that have Diabetic Ketoacidosis
Diabetic Ketoacidosis includes uncontrolled hyperglycemia, anion gap metabolic acidosis, and ketosis
Measured: during labor(for up to 200 hours)
Maximum insulin Glucose tolerance test (GTT) rate
Measured: during labor(for up to 200 hours)
Number of participants that utilize insulin drip
Measured: during labor(for up to 200 hours)
Number of participants that undergo primary cesarean section
Measured: at time of delivery
Number of participants that have Postpartum hemorrhage
Postpartum hemorrhage is defined as greater than or equal to 1000ml or need for blood transfusion
Measured: from discharge until 6 months after birth
Number pf participants that have Intra-amniotic Infection
Intra-amniotic Infection is defined as clinically diagnosed infection of the uterine environment
Measured: intrapartum or within 24 hours of delivery
Number pf participants that have endometriosis
Endometritis is defined as clinically diagnosed uterine infection
Measured: Between 24 hours after delivery to 6 weeks of delivery
Number pf participants that have wound complications
Wound complications is defined as superficial or deep infections, fascial dehiscence
Measured: within 6 weeks of delivery
Number pf participants that require blood product transfusion
Measured: during admission (for up to 6 weeks after neonate delivery)
Resource utilization during labor as assessed by the number of accuchecks done
Measured: during delivery admission (labor or induction/augmentation) until delivery defined as time patient is admitted to labor and delivery until birth time of neonate, for up to 200 hours
Resource utilization during labor as assessed by the number of nurses utilized
Measured: during delivery admission (labor or induction/augmentation) until delivery defined as time patient is admitted to labor and delivery until birth time of neonate, for up to 200 hours
Total facility and physician costs for all the services provided to the mothers
Measured: From maternal admission time to maternal discharge time(upto 6 months form admission date)
Total facility and physician costs for all the services provided to the neonates
Measured: from birth time to discharge time defined as birth time of neonate until neonate is discharged from the hospital, up to 1 year
Total nurse time cost for monitoring the patients during labor
Measured: From admission time to delivery time defined as time patient is admitted to labor and delivery until birth time of neonate, for up to 200 hours
Number of gestational diabetes participants that do an oral glucose tolerance test (OGTT)
Measured: within 6- 8 weeks of delivery
Neonatal C-peptide levels from cord blood
Measured: at time of delivery
Number of neonates that have blood glucose level less than 40 mg/dL
Measured: within the first 24 hours of life
Number of neonates that have blood glucose level less than 40 mg/dL
Measured: during birth admission defined as birth time of neonate until neonate is discharged from hospital, up to 1 year
Number of neonates that need oral glucose supplementation
Measured: during birth admission defined as birth time of neonate until neonate is discharged from hospital, up to 1 year
Number of neonates that need IV glucose
Measured: during birth admission defined as birth time of neonate until neonate is discharged from hospital, up to 1 year
Lowest neonatal glucose level
Measured: during birth admission defined as birth time of neonate until neonate is discharged from hospital, up to 1 year
Mean neonatal glucose level in first 24 hours of life
Measured: during birth admission defined as birth time of neonate until neonate is discharged from hospital, up to 1 year
Lowest neonatal glucose level
Measured: first 24 hours of life
Number of neonates that required shoulder dystocia
Shoulder dystocia is defined as the need for any extra maneuvers, other than gentle downward traction of the fetal head to deliver the fetal body after the fetal head has been delivered
Measured: at time of delivery
Number of neonates that had birth injury
Birth injury as defined as skull, clavicular, humerus fracture, or brachial plexus
Measured: from birth and during admission defined as birth time of neonate until neonate is discharged from hospital, up to 1 year
Number of neonates that had respiratory distress
Respiratory distress is defined as the need for at least 4 hours of respiratory support with supplemental oxygen, continuous positive airway pressure, or ventilation
Measured: first 24 hours of life
Number of fetal deaths
Measured: during labor defined as time patient is admitted to labor and delivery until birth time of neonate, for up to 200 hours
Number of neonatal deaths
Measured: within 28 days of birth
Number of neonates with Apgar score of less than 7
Measured: 5 minutes from birth
Number of neonates that are admitted to Neonatal intensive care unit (NICU)
Measured: from birth up to 6 months from birth
Number of days neonates are admitted to NICU
Measured: from birth up to 6 months from birth
Number of neonates that have neonatal hyperbilirubinemia requiring phototherapy
Measured: during admission defined as birth time of neonate until neonate is discharged from hospital, up to 1 year
Maximum Bilirubin level
Measured: during admission defined as birth time of neonate until neonate is discharged from hospital, up to 1 year
Number of neonates that have hypocalcemia
Measured: during admission defined as birth time of neonate until neonate is discharged from hospital, up to 1 year
Number of neonates that have Necrotizing Enterocolitis
Measured: from birth up to 6 months from birth
Number of neonates that are small for gestational age
Small for gestational age is defined as a weight below 10th percentile of the expected value according to gestational age
Measured: at birth
Number of neonates that are large for gestational age
Large for gestational age is defined as a weight above 90th percentile of the expected value according to gestational age
Measured: at birth
Number of neonates that have Macrosomia
Macrosomia is defined as weight more than 4000 grams
Measured: at time of birth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2022
- Study start5 Oct 2022
- Primary completion2 Jul 2023
- Study completion13 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gestational DiabetesStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 96 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of Texas Health Science Center, Houston
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ghamar Bitar, The University of Texas Health Science Center, Houston
- Investigators
- Ghamar Bitar, MD, Principal investigator, The University of Texas Health Science Center, HoustonMichal F Bartar, MD, Principal investigator, The University of Texas Health Science Center, Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05553275
- Sponsor's protocol ID
- HSC-MS-22-0577
- Status last verified
- May 2024
- First submitted
- 9 Sep 2022
- Last updated
- 14 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Permissive Intrapartum Glucose Control: An Equivalence Randomized Control Study (PERMIT)
- ClinicalTrials.gov ID
- NCT05553275
- Acronym / sponsor ID
- HSC-MS-22-0577
- Conditions
- Gestational Diabetes, Pregestational Diabetes
- Keywords
- Diabetes Mellitus
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 96 participants (actual)
- Lead sponsor
- The University of Texas Health Science Center, HoustonUniversity, hospital or other
- Study start
- 5 Oct 2022 (actual)
- Primary completion
- 2 Jul 2023 (actual)
- Study completion
- 13 Aug 2023 (actual)
- First posted
- 23 Sep 2022 (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 permissive intrapartum glycemic control compared to usual care would lead to similar rate of neonatal hypoglycemia among people with diabetes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1:Usual Care | Active comparator | Procedure: Usual Care |
| Group 2: Permissive Care | Experimental | Procedure: Permissive intrapartum glucose control |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Singleton gestation
- Presenting for intrapartum management (induction, labor, augmentation)
- Any diagnosis of Type 1 Diabetes Mellitus(T1DM), Type 2 Diabetes Mellitus (T2DM), or Gestational Diabetes
- English or Spanish fluency
Key exclusion criteria (8 listed)
- Major fetal anomalies affecting glucose metabolism
- Multiple Gestation
- Incarcerated subjects
- less than 34 weeks gestation of pregnancy
- 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 |
|---|---|---|
| Usual CareBlood sugar evaluation (accuchecks) every four hours in latent labor and every 2 hours in active labor.Participants will be routinely managed with maintenance fluids of lactated ringers during latent labor and lactated ringers with dextrose 5% in active labor. Blood sugars of more than 110 mg/dl at any time point in labor will be treated with an insulin drip as follows: Regular insulin (100 units) in 100cc of normal saline, with Lactated Ringers with 5% dextrose at 125cc/hour. If blood sugar 111-140, insulin drip at 1 unit/hour will be given and continued if blood sugar is 111-140.If blood sugar is 141-180, then drip will be changed to to 1.5 unit/hour and if blood sugar is 181-220, drip will be changed to 2.0 units/hour and MD will be called if blood sugar is more than 221 mg/dl | Procedure or surgery | Group 1:Usual Care |
| Permissive intrapartum glucose controlBlood sugar evaluation (accuchecks) every four hours in latent labor and every 2 hours in active labor.Participants will be routinely management with maintenance fluids of lactated ringers during latent labor and lactated ringers with dextrose 5% in active labor.Blood sugars of more than 180 mg/dl at any time point in labor will be treated with an insulin drip as follows: Regular insulin (100 units) in 100cc of normal saline, with Lactated Ringers with 5% dextrose at 125cc/hour.If blood sugar is 181-200, insulin drip at 1 unit/hour will be given. If blood sugar is 201-220, then drip will be changed to 1.5 units/hour. If blood sugar is 221 - 250, then drip will be changed to 2.0 units/hour and if blood sugar is more than 251 MD will be called. | Procedure or surgery | Group 2: Permissive Care |
Primary outcome
first neonatal blood glucose level measured in mg/dL
Time frame: up to 2 hours of life prior to first feed
44 secondary outcomes
Number of intrapartum glucose measurements
Time frame: During Labor(for up to 200 hours)
Mean maternal glucose values in mg/dl
Time frame: during latent labor(for up to 200 hours)
Mean maternal glucose values in mg/dl
Time frame: during active labor(for up to 200 hours)
Overall mean maternal glucose values in mg/dl
Time frame: in all of labor(for up to 200 hours)
Number of participants that have hyperglycemia episodes
Time frame: during labor( for up to 200 hours)
Number of participants that have hypoglycemia episodes
Time frame: during labor(for up to 200 hours)
Number of participants that have Diabetic Ketoacidosis
Time frame: during labor(for up to 200 hours)
Maximum insulin Glucose tolerance test (GTT) rate
Time frame: during labor(for up to 200 hours)
Number of participants that utilize insulin drip
Time frame: during labor(for up to 200 hours)
Number of participants that undergo primary cesarean section
Time frame: at time of delivery
Number of participants that have Postpartum hemorrhage
Time frame: from discharge until 6 months after birth
Number pf participants that have Intra-amniotic Infection
Time frame: intrapartum or within 24 hours of delivery
Number pf participants that have endometriosis
Time frame: Between 24 hours after delivery to 6 weeks of delivery
Number pf participants that have wound complications
Time frame: within 6 weeks of delivery
Number pf participants that require blood product transfusion
Time frame: during admission (for up to 6 weeks after neonate delivery)
Resource utilization during labor as assessed by the number of accuchecks done
Time frame: during delivery admission (labor or induction/augmentation) until delivery defined as time patient is admitted to labor and delivery until birth time of neonate, for up to 200 hours
Resource utilization during labor as assessed by the number of nurses utilized
Time frame: during delivery admission (labor or induction/augmentation) until delivery defined as time patient is admitted to labor and delivery until birth time of neonate, for up to 200 hours
Total facility and physician costs for all the services provided to the mothers
Time frame: From maternal admission time to maternal discharge time(upto 6 months form admission date)
Total facility and physician costs for all the services provided to the neonates
Time frame: from birth time to discharge time defined as birth time of neonate until neonate is discharged from the hospital, up to 1 year
Total nurse time cost for monitoring the patients during labor
Time frame: From admission time to delivery time defined as time patient is admitted to labor and delivery until birth time of neonate, for up to 200 hours
Number of gestational diabetes participants that do an oral glucose tolerance test (OGTT)
Time frame: within 6- 8 weeks of delivery
Neonatal C-peptide levels from cord blood
Time frame: at time of delivery
Number of neonates that have blood glucose level less than 40 mg/dL
Time frame: within the first 24 hours of life
Number of neonates that have blood glucose level less than 40 mg/dL
Time frame: during birth admission defined as birth time of neonate until neonate is discharged from hospital, up to 1 year
Number of neonates that need oral glucose supplementation
Time frame: during birth admission defined as birth time of neonate until neonate is discharged from hospital, up to 1 year
Number of neonates that need IV glucose
Time frame: during birth admission defined as birth time of neonate until neonate is discharged from hospital, up to 1 year
Lowest neonatal glucose level
Time frame: during birth admission defined as birth time of neonate until neonate is discharged from hospital, up to 1 year
Mean neonatal glucose level in first 24 hours of life
Time frame: during birth admission defined as birth time of neonate until neonate is discharged from hospital, up to 1 year
Lowest neonatal glucose level
Time frame: first 24 hours of life
Number of neonates that required shoulder dystocia
Time frame: at time of delivery
Number of neonates that had birth injury
Time frame: from birth and during admission defined as birth time of neonate until neonate is discharged from hospital, up to 1 year
Number of neonates that had respiratory distress
Time frame: first 24 hours of life
Number of fetal deaths
Time frame: during labor defined as time patient is admitted to labor and delivery until birth time of neonate, for up to 200 hours
Number of neonatal deaths
Time frame: within 28 days of birth
Number of neonates with Apgar score of less than 7
Time frame: 5 minutes from birth
Number of neonates that are admitted to Neonatal intensive care unit (NICU)
Time frame: from birth up to 6 months from birth
Number of days neonates are admitted to NICU
Time frame: from birth up to 6 months from birth
Number of neonates that have neonatal hyperbilirubinemia requiring phototherapy
Time frame: during admission defined as birth time of neonate until neonate is discharged from hospital, up to 1 year
Maximum Bilirubin level
Time frame: during admission defined as birth time of neonate until neonate is discharged from hospital, up to 1 year
Number of neonates that have hypocalcemia
Time frame: during admission defined as birth time of neonate until neonate is discharged from hospital, up to 1 year
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 May 2024.
- Individual participant dataSharing planned: No
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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.
Ghamar Bitar, MD principal investigator
The University of Texas Health Science Center, Houston
Michal F Bartar, MD principal investigator
The University of Texas Health Science Center, Houston
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Gestational Diabetes and Pregestational Diabetes, run by The University of Texas Health Science Center, Houston 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 8 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 May 2024. 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?
first neonatal blood glucose level measured in mg/dL (time frame: up to 2 hours of life prior to first feed). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 May 2024.