Assessment of Fetal Pancreatic Size and Maternal Serum Biomarkers Glycated Albumin and Insulin-regulated Aminopeptidase in Women With Gestational Diabetes Mellitus
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 109
- Locations
- 1
- Primary Endpoint
- Early prediction of gestational diabetes
Study 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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to 42 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- Yes
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
Secondary Outcomes
No secondary outcomes reported