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

Not Applicable

Completed

• Conditions: Gestational Diabetes; DUCTUS VENOSUS VOLUME; PLACENTA VOLUME; 3D SONOGRAPHY; FETAL LİVER VOLUME
• Interventions: Other: 3D sonography

• Registration Number: NCT06178250
• Lead Sponsor: Sanliurfa Mehmet Akif Inan Education and Research Hospital

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.

Study Timeline

• Study Start: 2021-09-22
• Primary Completion: 2022-07-31
• Study Completion: 2022-07-31
• Status Verified: 2023-12
• Study First Submitted: 2023-12-03
• Study First Submitted QC: 2023-12-11
• Last Update Submitted: 2023-12-11
• Study First Posted: 2023-12-20
• Last Update Posted: 2023-12-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 139

Inclusion Criteria

• singleton pregnancy
• diagnosed with GDM

Exclusion Criteria

• multiple pregnancy
• congenital anomalies
• gestational hypertansion
• preeclampsia

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
placenta, fetal liver, sectional ductus venosus volumes between 24-29 weeks pregnant women	3D sonography	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.

Primary Outcome Measures

Name	Time	Method
Fetal liver volume in ultrasound	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	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	10 months	Measured placenta volumes of pregnant women with GDM diagnosis and normal glycemic indices and evaluate their success in predicting poor obstetrics outcomes

Trial Locations

Locations (1)

Nefise Nazlı YENIGUL; 🇹🇷 Bursa, Turkey