A Comparative Analysis of Fetal Cerebral Blood Flow Using 3D Power Doppler Ultrasound as a Predictor of Adverse Perinatal Outcomes in Diabetic and Normal Pregnancies

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

TCTR

Registry ID

TCTR20250501005

Enrollment

316

Registered

2025-05-01

Start date

2025-03-01

Completion date

Unknown

Last updated

2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Abnormal fetal cerebral blood flow and adverse perinatal outcomes associated with maternal diabetes Diabetes in pregnancy Three dimensional power Doppler ultrasound Fetal cerebral vascularization Flow index Vascularization index

Interventions

Singleton pregnant women with gestational age between 37+0 and 40+6 weeks who have either gestational diabetes mellitus or pregestational diabetes,Singleton pregnant women with gestational age between

Diagnostic,Diagnostic

Diabetes group,Non Diabetes group

Eligibility

Sex/Gender

Female

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Singleton pregnancy 2. Gestational age 37+0 - 40+6 weeks 3. Variable fetus 4. Delivery at Bhumibol Adulyadej Hospital or availability of accessible delivery records 5. Signed informed consent to participate in the study

Exclusion criteria

Exclusion criteria: 1. Singleton pregnancy with underlying disease of HIV infetion, SLE, Autoimmune diseases, Pregestational hypertension, Thyroid disease 2. Confirmed detection of abnormal fetal genetic material 3. Confirmed detection of abnormal fetal anatomical structure

Design outcomes

Primary

Measure	Time frame
Vascularization Index (VI) At 37+0 to 40+6 weeks of gestation Measured using 3D power Doppler ultrasound with VOCAL software analysis; expressed as the percentage of color Doppler signal voxels within a spherical volume around the fetal brain (Circle of Willis),Flow Index (FI) At 37+0 to 40+6 weeks of gestation Measured using 3D power Doppler ultrasound with VOCAL software analysis; expressed as the percentage of color Doppler signal voxels within a spherical volume around the fetal brain (Circle of Willis),Vascularization Flow Index (VFI) At 37+0 to 40+6 weeks of gestation Combined measurement of vascularization and flow using 3D power Doppler ultrasound with VOCAL software,Cerebroplacental Ratio (CPR) At 37+0 to 40+6 weeks of gestation Calculated as the ratio between the pulsatility index (PI) of the middle cerebral artery and the umbilical artery using 2D Doppler ultrasound,Adverse perinatal outcomes At delivery and in the postpartum period Collected from medical records	—

Measure

Time frame

Vascularization Index (VI) At 37+0 to 40+6 weeks of gestation Measured using 3D power Doppler ultrasound with VOCAL software analysis; expressed as the percentage of color Doppler signal voxels within a spherical volume around the fetal brain (Circle of Willis),Flow Index (FI) At 37+0 to 40+6 weeks of gestation Measured using 3D power Doppler ultrasound with VOCAL software analysis; expressed as the percentage of color Doppler signal voxels within a spherical volume around the fetal brain (Circle of Willis),Vascularization Flow Index (VFI) At 37+0 to 40+6 weeks of gestation Combined measurement of vascularization and flow using 3D power Doppler ultrasound with VOCAL software,Cerebroplacental Ratio (CPR) At 37+0 to 40+6 weeks of gestation Calculated as the ratio between the pulsatility index (PI) of the middle cerebral artery and the umbilical artery using 2D Doppler ultrasound,Adverse perinatal outcomes At delivery and in the postpartum period Collected from medical records

—

Secondary

Measure	Time frame
Optimum cut-off values of fetal cerebral vascular indices for predicting adverse perinatal outcomes Vascular indices measured at 37+0 to 40+6 weeks of gestation; perinatal outcomes assessed at delivery and in the immediate postpartum period Receiver Operating Characteristic (ROC) curve analysis	—

Countries

Thailand

Contacts

Public ContactPONGPOL KHUHATHONG

Bhumibol Adulyadej Hospital

pongpol.medicate@gmail.com0972418860

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 10, 2026