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

NCT ID: NCT06178250

Last Updated: 2023-12-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

139 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-09-22

Study Completion Date

2022-07-31

Brief Summary

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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

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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.

Conditions

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

Keywords

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

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

46 pregnant women diagnosed with gestational diabetes mellitus, 93 pregnant women with normal glycemic index
Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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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.

Group Type OTHER

3D sonography

Intervention Type OTHER

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

Interventions

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3D sonography

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

Intervention Type OTHER

Other Intervention Names

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3D volume description

Eligibility Criteria

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Inclusion Criteria

* singleton pregnancy
* diagnosed with GDM

Exclusion Criteria

* multiple pregnancy
* congenital anomalies
* gestational hypertansion
* preeclampsia
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Sanliurfa Mehmet Akif Inan Education and Research Hospital

OTHER

Sponsor Role lead

Responsible Party

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Nefise Nazlı YENIGUL

Ph.D. Assistant Professor Department of Obstetrics and Gynecology

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Nefise Nazlı YENIGUL

Bursa, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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2011-KAEK-25 2021/10-09

Identifier Type: -

Identifier Source: org_study_id