Group 2: Permissive Care for Gestational Diabetes

The University of Texas Health Science Center at Houston, Houston, TX
Gestational Diabetes+1 More ConditionsPermissive intrapartum glucose control - Procedure
Eligibility

Study Summary

This trial will compare permissive intrapartum glycemic control to usual care in order to see if it leads to a similar rate of neonatal hypoglycemia in people with diabetes.

Eligible Conditions
  • Gestational Diabetes
  • Pre-Gestational Diabetes

Treatment Effectiveness

Phase-Based Effectiveness

1 of 3
N/A

Study Objectives

1 Primary · 41 Secondary · Reporting Duration: during admission defined as birth time of neonate until neonate is discharged from hospital, up to 1 year

5 minutes from birth
Number of neonates with Apgar score of less than 7
Week 6
Number pf participants that have endometriosis
Hour 200
Number of intrapartum glucose measurements
Hour 200
Total nurse time cost for monitoring the patients during labor
Month 6
Total facility and physician costs for all the services provided to the mothers
at birth
Number of neonates that are large for gestational age
Number of neonates that are small for gestational age
at time of birth
Number of neonates that have Macrosomia
at time of delivery
C-Peptide
Number of neonates that required shoulder dystocia
Number of participants that undergo primary cesarean section
Hour 200
Glucose
Week 6
Number pf participants that require blood product transfusion
Year 1
Bilirubin
Number of neonates that have hypocalcemia
Phototherapy
Year 1
Mean neonatal glucose level in first 24 hours of life
Number of neonates that have blood glucose level less than 40 mg/dL
Number of neonates that need IV glucose
Number of neonates that need oral glucose supplementation
Hour 200
Resource utilization during labor as assessed by the number of accuchecks done
Resource utilization during labor as assessed by the number of nurses utilized
Hour 200
Number of fetal deaths
Hour 200
Number of participants that have hyperglycemia episodes
Hour 200
Glucose tolerance test
Diabetic Ketoacidosis
Hypoglycemia
Insulin
Hour 24
Lowest neonatal glucose level
Number of neonates that had respiratory distress
Year 1
Number of neonates that had birth injury
Year 1
Total facility and physician costs for all the services provided to the neonates
Month 6
Number of days neonates are admitted to NICU
Number of neonates that are admitted to Neonatal intensive care unit (NICU)
Necrotizing Enterocolitis
Month 6
Postpartum Hemorrhage
Hour 200
Overall mean maternal glucose values in mg/dl
Hour 24
Number pf participants that have Intra-amniotic Infection
Hour 2
Blood Glucose
Day 28
Number of neonatal deaths
Week 6
Number pf participants that have wound complications
Week 8
Glucose tolerance test

Trial Safety

Phase-Based Safety

1 of 3

Awards & Highlights

No Placebo Group
All patients enrolled in this trial will receive the new treatment.

Trial Design

2 Treatment Groups

Group 1:Usual Care
1 of 2
Group 2: Permissive Care
1 of 2

Active Control

Experimental Treatment

96 Total Participants · 2 Treatment Groups

Primary Treatment: Group 2: Permissive Care · No Placebo Group · N/A

Group 2: Permissive Care
Procedure
Experimental Group · 1 Intervention: Permissive intrapartum glucose control · Intervention Types: Procedure
Group 1:Usual Care
Procedure
ActiveComparator Group · 1 Intervention: Usual Care · Intervention Types: Procedure

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: during admission defined as birth time of neonate until neonate is discharged from hospital, up to 1 year

Who is running the clinical trial?

The University of Texas Health Science Center, HoustonLead Sponsor
836 Previous Clinical Trials
263,945 Total Patients Enrolled
Michal F Bartar, MDPrincipal InvestigatorThe University of Texas Health Science Center, Houston
Ghamar Bitar, MDPrincipal InvestigatorThe University of Texas Health Science Center, Houston

Eligibility Criteria

Age 18+ · Female Participants · 1 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You are pregnant with only one baby.

Frequently Asked Questions

Is registration for this investigation currently open?

"The trial is actively recruiting, as per clinicaltrials.gov; the research was initially posted on October 5th 2022 and underwent its most recent edit on October 7th of that year." - Anonymous Online Contributor

Unverified Answer

How many participants are currently approved to be included in this clinical investigation?

"Yes, it has been verified that this medical experiment is open for recruitment. The trial was first announced on October 5th 2022 and the information was last refreshed on October 7th 2022. 96 patients will be accepted from a single clinical site." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.