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CompletedNCT06178250Updated Dec 20, 2023

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

An interventional study of 3D sonography in Gestational Diabetes, DUCTUS VENOSUS VOLUME and PLACENTA VOLUME, sponsored by Sanliurfa Mehmet Akif Inan Education and Research Hospital. Completed at 1 site in Turkey. Open to female participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-12-20.

Sponsored by Sanliurfa Mehmet Akif Inan Education and Research Hospital · Not applicable, Interventional, and Other

From the registry’s dates

  • Registered 2 years 2 months after the study started (first participant enrolled Sep 2021, registered Dec 2023).
Phase
Not applicable
Study type
Interventional
Enrollment
139
Allocation
Not applicable
Ages
18 Years to 45 Years
Sex
Female
01

Study 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

Read the 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.

02

Conditions studied

  • Gestational Diabetes
  • DUCTUS VENOSUS VOLUME
  • PLACENTA VOLUME
  • 3D SONOGRAPHY
  • FETAL LİVER VOLUME

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Keywords

  • GESTATİONAL DİABETES MELLİTUS
  • PLACENTA VOLUME
  • FETAL LİVER VOLUME
  • DUCTUS VENOSUS VOLUME
  • 3D SONUGRAPHY
03

In context

Diabetes, Gestational

842 studies on the registry are indexed under Diabetes, Gestational; 198 are open to participants now.

This study's enrollment of 139 is above the median of 110 across 550 interventional studies indexed under Diabetes, Gestational.

Browse Diabetes, Gestational studies →

Lead sponsor

Sanliurfa Mehmet Akif Inan Education and Research Hospital is the lead sponsor of 27 studies on the registry; 7 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

Inclusion criteria

  • singleton pregnancy
  • diagnosed with GDM

Exclusion criteria

Exclusion Criteria:

  • multiple pregnancy
  • congenital anomalies
  • gestational hypertansion
  • preeclampsia
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
139 participants (actual)

Study arms

  • Other
    placenta, fetal liver, sectional ductus venosus volumes between 24-29 weeks pregnant women

    The placenta, fetal liver and ductus venosus volumes of 46 patients diagnosed with GDM and 93 patients without a GDM diagnosis between 24-29 weeks were evaluated with 3D ultrasound.

    Other: 3D sonography

Interventions

  • Other3D sonography

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

    Also known as: 3D volume description

06

What researchers measure

Primary outcomes

  1. Placenta volume in ultrasound

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

    Time frame: 10 months

  2. Fetal liver volume in ultrasound

    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

    Time frame: 10 months

  3. Ductus venosus volume in ultrasound

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

    Time frame: 10 months

07

Study locations

1 site
  • Nefise Nazlı YENIGUL
    Bursa, 16110, Turkey
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 20, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06178250
Lead sponsor
Sanliurfa Mehmet Akif Inan Education and Research Hospital
Responsible party
Nefise Nazlı YENIGUL (Ph.D. Assistant Professor Department of Obstetrics and Gynecology, Sanliurfa Mehmet Akif Inan Education and Research Hospital) — Principal investigator
First posted
Dec 20, 2023
Start date
Sep 22, 2021
Primary completion
Jul 31, 2022
Completion
Jul 31, 2022
Last update
Dec 20, 2023

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2023. You cannot join it, but the record below documents what was studied.

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