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Clinical Trials/NCT05392231
NCT05392231
Completed
Not Applicable

Assessment of Fetal Pancreatic Size and Maternal Serum Biomarkers Glycated Albumin and Insulin-regulated Aminopeptidase in Women With Gestational Diabetes Mellitus

Haseki Training and Research Hospital1 site in 1 country109 target enrollmentFebruary 10, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Gestational Diabetes
Sponsor
Haseki Training and Research Hospital
Enrollment
109
Locations
1
Primary Endpoint
Early prediction of gestational diabetes
Status
Completed
Last Updated
3 years ago

Overview

Brief Summary

The investigators aimed to determine the predictive values of fetal pancreas size and maternal serum biomarkers glycated albumin (GA) and insulin-regulated aminopeptidase (IRAP) for gestational diabetes mellitus (GDM).

Detailed Description

The investigators aimed to determine the predictive values of fetal pancreas size and maternal serum biomarkers glycated albumin (GA) and insulin-regulated aminopeptidase (IRAP) for gestational diabetes mellitus (GDM).In this prospective observational study including 109 pregnant women, the fetal pancreas size and maternal serum biomarkers GA and IRAP were measured at the gestational age of 20-22 weeks and later at the gestational age of 24-28 weeks, in 19 participants of them, GDM was confirmed with the 75-g oral glucose tolerance test (OGTT) and the fetal pancreas size was measured in all the participants again.

Registry
clinicaltrials.gov
Start Date
February 10, 2022
End Date
May 10, 2022
Last Updated
3 years ago
Study Type
Observational
Sex
Female

Investigators

Sponsor
Haseki Training and Research Hospital
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Maternal age between 18 and 42 years
  • Gestational age between 20 and 28 weeks

Exclusion Criteria

  • Multiple pregnancies
  • Pregestational diabetes
  • Fetal congenital malformations
  • Placental and amniotic fluid abnormalities
  • Preeclampsia
  • Severe systemic disease
  • Long-term systemic drug usage

Outcomes

Primary Outcomes

Early prediction of gestational diabetes

Time Frame: Two months

Early prediction of gestational diabetes by the fetal pancreas measurement with ultrasound and maternal serum biomarkers glycated albumin and insulin-regulated aminopeptidase measured with ELISA

Study Sites (1)

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