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Glucose Control for Gestational Diabetes
N/A
Waitlist Available
Led By Praveen Ramesh, M.D.
Research Sponsored by University of Pittsburgh
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Pregnant patients with Pre-gestational (Type 1 or Type 2) or Gestational Diabetes
Timeline
Screening 3 weeks
Treatment Varies
Follow Up during labor( for up to 200 hours)
Awards & highlights
No Placebo-Only Group
Summary
This trial aims to determine if keeping blood sugar levels higher during childbirth in diabetic patients will reduce the chances of newborns experiencing low blood sugar levels.
Who is the study for?
This trial is for pregnant individuals in labor who have diabetes, aiming to reduce the risk of their newborns having low blood sugar. Participants should meet specific health criteria and not be part of any other similar studies.
What is being tested?
The study compares two glucose control strategies during labor: a 'standard' range versus a more 'liberalized' range, to see which is better at preventing low blood sugar in newborns.
What are the potential side effects?
Potential side effects are not explicitly listed but may include variations in maternal blood sugar levels that could affect both mother and baby's health.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am pregnant and have diabetes (Type 1, Type 2, or gestational).
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ during labor( for up to 200 hours)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~during labor( for up to 200 hours)
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Immediate postnatal Neonatal hypoglycemia
Secondary study objectives
Any neonatal hypoglycemia
Maternal Intrapartum Hyperglycemia
Maternal intrapartum hypoglycemia
+4 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Liberalized Intrapartum Glucose Target RangeExperimental Treatment1 Intervention
The goal intrapartum glucose target range will be 70-160mg/dl. Insulin infusion will be initiated when maternal capillary glucose exceeds 160 mg/dL.
Group II: Standard Intrapartum Glucose Target RangeActive Control1 Intervention
The goal intrapartum glucose target range will be 70-110mg/dl. Insulin infusion will be initiated when maternal capillary glucose exceeds 110 mg/dL.
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Who is running the clinical trial?
University of PittsburghLead Sponsor
1,789 Previous Clinical Trials
16,359,405 Total Patients Enrolled
Praveen Ramesh, M.D.Principal InvestigatorUniversity of Pittsburgh
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