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Permissive Glucose Control for Gestational Diabetes

N/A

Waitlist Available

Led By Michal F Bartar, MD

Research Sponsored by The University of Texas Health Science Center, Houston

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

English or Spanish fluency

Any diagnosis of Type 1 Diabetes Mellitus(T1DM), Type 2 Diabetes Mellitus (T2DM), or Gestational Diabetes

Timeline

Screening 3 weeks

Treatment Varies

Follow Up during admission defined as birth time of neonate until neonate is discharged from hospital, up to 1 year

Awards & highlights

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.

Who is the study for?

This trial is for pregnant individuals with single pregnancies at or beyond 34 weeks, who have Type 1, Type 2, or Gestational Diabetes and are fluent in English or Spanish. It's not for those using insulin pumps during labor, experiencing diabetic ketoacidosis (DKA), carrying multiple babies, dealing with major fetal anomalies affecting glucose metabolism, incarcerated subjects, stillbirths, or planning cesarean deliveries.Check my eligibility

What is being tested?

The study compares permissive intrapartum glycemic control to usual care in managing blood sugar levels during labor. The goal is to see if a more lenient approach leads to the same rates of neonatal hypoglycemia (low blood sugar in newborns) as standard treatment.See study design

What are the potential side effects?

Potential side effects may include variations in maternal blood glucose levels which could affect both mother and baby. For the baby specifically, there might be risks related to abnormal blood sugar levels after birth.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am fluent in English or Spanish.

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I have been diagnosed with Type 1, Type 2, or Gestational Diabetes.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ during admission defined as birth time of neonate until neonate is discharged from hospital, up to 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~during admission defined as birth time of neonate until neonate is discharged from hospital, up to 1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and during admission defined as birth time of neonate until neonate is discharged from hospital, up to 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Blood Glucose

Secondary outcome measures

Lowest neonatal glucose level

Bilirubin

Glucose tolerance test

+38 more

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Group 2: Permissive CareExperimental Treatment1 Intervention

Group II: Group 1:Usual CareActive Control1 Intervention

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

The University of Texas Health Science Center, HoustonLead Sponsor

904 Previous Clinical Trials

320,901 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

Media Library

Gestational Diabetes Clinical Trial 2023: Permissive intrapartum glucose control Highlights & Side Effects. Trial Name: NCT05553275 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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."

Answered by AI

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."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Permissive Intrapartum Glucose Control

Ghamar Bitar 2022. "Permissive Intrapartum Glucose Control". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05553275.