The fetal pancreatic echogenicity for prediction of gestational diabetes mellitus

Recruiting

• Conditions: Fetal pancreatic echogenicity in gestational diabetes meliitus; Fetal pancreas; Pancreatic echogenicity; Fetal pancreatic sonogram; Gestational diabetes mellitus

• Registration Number: TCTR20220316002
• Lead Sponsor: /A

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2022-03-16
• Study Completion: 2022-12-30
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Female
• Target Recruitment: 100

Inclusion Criteria

1.Singleton pregnancies between 24 and 28 weeks of gestation
2.Accurate gestational age confirmed before 20 weeks of gestation
3.Will apply for two-step test for GDM

Exclusion Criteria

1.Fetal anomalies or chromosome abnormalities
2.Pregestational DM
3.GDM diagnosed before 24 weeks of gestation
4.Underlying disease of carbohydrate or lipid metabolism
5.Poor imaging of fetal pancreas on USG examination

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The incidence of GDM After the ultrasound examination until delivery Two-step approach: 50g GCT cut-off at 140 mg/dL, 100g OGTT with Carpenter and Coustan criteria

Secondary Outcome Measures

Name	Time	Method
HbA1C level On the day of enrollment Blood test,Pancreatic size On the day of enrollment Ultrasound examination of fetal pancreatic circumference, AP and transverse diameter, measured by free-hand trace method,Pancreatic volume On the day of enrollment 3D-ultrasound examination, processed with Virtual Organ Computer-Aided Analysis (VOCAL) software (GE Healthcare) using step rotation of 30 degrees in 6 planes,Gestational age at delivery At delivery Medical record,Mode of delivery At delivery Medical record,Birth weight and length At delivery Medical record,APGAR score At delivery Medical record,Neonatal hypoglycemia At delivery Medical record