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NCT05392231 Clinical Trial

Assessment of Fetal Pancreatic Size and Maternal Serum Biomarkers in GDM

Gestational Diabetes Clinical Trial

— PS-GDM-2022  

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05392231
Other study ID # 05-2022
Secondary ID
Status Completed
Phase
First received
Last updated
Start date February 10, 2022
Est. completion date May 10, 2022

Study information
Verified date May 2022
Source Haseki Training and Research Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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).

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.

Recruitment information / eligibility
Status Completed
Enrollment 109
Est. completion date May 10, 2022
Est. primary completion date April 30, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 42 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
Turkey Haseki Training and Research Hospital Istanbul

Sponsors (1)
Lead Sponsor Collaborator
Haseki Training and Research Hospital

Country where clinical trial is conducted

Turkey, 

Outcome
Type Measure Description Time frame Safety issue
Primary Early prediction of gestational diabetes 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 Two months
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