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Clinical Trials/NCT06178250
NCT06178250
Completed
Not Applicable

The Role of Placenta, Fetal Liver, Sectional Ductus Venosus Volumes Examined by Three-dimensional Ultrasound in the Second Trimester in Predicting Gestational Diabetes Mellitus and Maternal-fetal Outcomes

Sanliurfa Mehmet Akif Inan Education and Research Hospital1 site in 1 country139 target enrollmentSeptember 22, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Gestational Diabetes
Sponsor
Sanliurfa Mehmet Akif Inan Education and Research Hospital
Enrollment
139
Locations
1
Primary Endpoint
Fetal liver volume in ultrasound
Status
Completed
Last Updated
2 years ago

Overview

Brief Summary

Investigators measured the placenta, fetal liver and ductus venosus volumes of pregnant women with GDM diagnosis and normal glycemic indices in the second trimester.Investigators aimed to correlate measurements with maternal/fetal outcomes and evaluate their success in predicting poor obstetric outcomes

Detailed Description

GDM screening may not always be possible with OGTT performed in limited weeks of gestation. In addition, mid-trimester ultrasound scanning is done in all pregnancies. Therefore, measurement of placental volume and fetal liver volume may be an alternative method for the diagnosis of GDM. In order to predict GDM in the second trimester, the use of 3D sonography and VOCAL (Virtual Organ Computer Aided Analysis) technology in high-risk pregnant women and their cost-effectiveness rates should be investigated further. Multicenter randomized controlled studies with more patients are needed to be able to say more clearly.

Registry
clinicaltrials.gov
Start Date
September 22, 2021
End Date
July 31, 2022
Last Updated
2 years ago
Study Type
Interventional
Study Design
Single Group
Sex
Female

Investigators

Sponsor
Sanliurfa Mehmet Akif Inan Education and Research Hospital
Responsible Party
Principal Investigator
Principal Investigator

Nefise Nazlı YENIGUL

Ph.D. Assistant Professor Department of Obstetrics and Gynecology

Sanliurfa Mehmet Akif Inan Education and Research Hospital

Eligibility Criteria

Inclusion Criteria

  • singleton pregnancy
  • diagnosed with GDM

Exclusion Criteria

  • multiple pregnancy
  • congenital anomalies
  • gestational hypertansion
  • preeclampsia

Outcomes

Primary Outcomes

Fetal liver volume in ultrasound

Time Frame: 10 months

Measured fetal liver and ductus venosus volumes of pregnant women with GDM diagnosis and normal glycemic indices and evaluate their success in predicting poor obstetrics outcomes

Ductus venosus volume in ultrasound

Time Frame: 10 months

Measured ductus venosus volumes of pregnant women with GDM diagnosis and normal glycemic indices and evaluate their success in predicting poor obstetrics outcomes

Placenta volume in ultrasound

Time Frame: 10 months

Measured placenta volumes of pregnant women with GDM diagnosis and normal glycemic indices and evaluate their success in predicting poor obstetrics outcomes

Study Sites (1)

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