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

NCT06178250 | Completed DMC

• 1 other identifier: 2011-KAEK-25 2021/10-09
• Study Type: interventional
• Target: 139
• Locations: 1 country
• Sites: 1

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

Conditions

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

Keywords

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

Outcome Measures

Primary Outcomes (3)

• 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

  10 months

• 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

  10 months

• 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

  10 months

Study Arms (1)

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

OTHER

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

3D sonography OTHER

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

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

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• singleton pregnancy
• diagnosed with GDM

You may not qualify if:

• multiple pregnancy
• congenital anomalies
• gestational hypertansion
• preeclampsia

Sponsors & Collaborators

• Sanliurfa Mehmet Akif Inan Education and Research Hospital: lead

Study Sites (1)

Nefise Nazlı YENIGUL

Bursa, 16110, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Diabetes, Gestational

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Ph.D. Assistant Professor Department of Obstetrics and Gynecology

Model Details: 46 pregnant women diagnosed with gestational diabetes mellitus, 93 pregnant women with normal glycemic index

Study Record Dates

• First Submitted: December 3, 2023
• First Posted: December 20, 2023
• Study Start: September 22, 2021
• Primary Completion: July 31, 2022
• Study Completion: July 31, 2022
• Last Updated: December 20, 2023

Record last verified: 2023-12

Locations

TU (1)