Assessment of Fetal Pancreatic Size and Maternal Serum Biomarkers in GDM (PS-GDM-2022)

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

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).

Study Overview

• Status: Completed
• Conditions: Gestational Diabetes

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 Type: Observational
• Enrollment (Actual): 109

Contacts and Locations

Study Locations

• Turkey
  • İstanbul, Turkey
    • Haseki Training and Research Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 42 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

With a design of prospective observational study, this research was carried out in the Perinatology Clinic of Haseki Hospital, affiliated with the University of Health Sciences, in Istanbul, between September 2021 and April 2022, following the approval of the local ethics committee (date: February 09, 2022, Registry No: 05-2022) and the valid Helsinki Declaration. After all the objectives of this work and context of all the procedures that could be undertaken were properly explained to each pregnant woman, the participant was requested to sign an informed written consent form.

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Haseki Training and Research Hospital

Study record dates

Study Major Dates

• Study Start (Actual): February 10, 2022
• Primary Completion (Actual): April 30, 2022
• Study Completion (Actual): May 10, 2022

Study Registration Dates

• First Submitted: May 22, 2022
• First Submitted That Met QC Criteria: May 22, 2022
• First Posted (Actual): May 26, 2022

Study Record Updates

• Last Update Posted (Actual): June 1, 2022
• Last Update Submitted That Met QC Criteria: May 26, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Pregnancy Complications; Diabetes, Gestational
• Other Study ID Numbers: 05-2022

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No