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Pregnancies with GDM and BMI > 30 for Fetal Macrosomia

N/A
Recruiting
Led By Gene T Lee, MD
Research Sponsored by University of Kansas Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 0.5, 3, and 6 months
Awards & highlights

Study Summary

This is a prospective, observational study which examines the association between maternal triglycerides in the antepartum period and fetal overgrowth in pregnancies complicated by gestational diabetes. Mothers are asked to provide 2 blood samples, undergo fingerstick blood measurements, and to have their newborns measured for body fat composition in the first 6 months of life.

Eligible Conditions
  • Fetal Macrosomia
  • Obesity
  • Gestational Diabetes

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~0.5, 3, and 6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 0.5, 3, and 6 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Correlation coefficient between triglyceride levels and birthweight
Secondary outcome measures
Correlation coefficient between triglyceride levels and body fat distribution
Correlation coefficient between triglyceride levels and cord c-peptide levels
Correlation coefficient between triglyceride levels and total fat mass

Side effects data

From 2016 Phase 3 trial • 356 Patients • NCT00048997
31%
Fatigue (lethargy, malaise, asthenia)
23%
Alopecia
17%
Late RT Toxicity: Other: NOS
11%
Nausea
10%
Anorexia
9%
Late RT Toxicity: Brain: NOS
9%
Headache
7%
Late RT Toxicity: Skin: NOS
6%
Memory loss
1%
Dyspnea (shortness of breath)
1%
Mood alteration-depression
1%
Hemorrhage-Other
1%
Ataxia (incoordination)
1%
Pain-Other
100%
80%
60%
40%
20%
0%
Study treatment Arm
Prophylactic Cranial Irradiation (PCI)

Trial Design

1Treatment groups
Experimental Treatment
Group I: Pregnancies with GDM and BMI > 30Experimental Treatment1 Intervention
Pregnancies with GDM diagnosed between 24-32 weeks and BMI > 30.

Find a Location

Who is running the clinical trial?

University of Kansas Medical CenterLead Sponsor
462 Previous Clinical Trials
169,163 Total Patients Enrolled
Gene T Lee, MDPrincipal InvestigatorUniversity of Kansas Medical Center
1 Previous Clinical Trials
7 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Investigating the Relationship Between Triglycerides and Fetal Overgrowth in Gestational Diabetes
Gene Lee, MD 2023. "Investigating the Relationship Between Triglycerides and Fetal Overgrowth in Gestational Diabetes". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06067685.
All > Kansas City
~12 spots leftby Aug 2024
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