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Completed

NCT Number: NCT06178250

Placenta, Fetal Liver, Sectional Ductus Venosus Volumes Examined by Three-dimensional Ultrasound in the Second Trimester

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

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • singleton pregnancy
  • diagnosed with GDM

Exclusion criteria

  • multiple pregnancy
  • congenital anomalies
  • gestational hypertansion
  • preeclampsia

Treatment and study plan

3D sonography

Other

Fetal liver, placenta, and ductus venosus were defined in 3 orthogonal multi-plane images in the voluson 4D view vocal program.

Other names: 3D volume description

Primary outcomes

  1. 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

  2. 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

  3. 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

Sponsors and collaborators

Lead sponsor

Sanliurfa Mehmet Akif Inan Education and Research Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Dec 20, 2023
Registry last updated
Dec 20, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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