Clinical Trials Directory

Trials / Completed

CompletedNCT06988436

FETAL PULMONARY VEIN AND UMBILICAL ARTERY PULSATILITY INDICES AS PREDICTORS OF FETAL GROWTH RESTRICTION IN DIABETIC AND HYPERTENSIVE PREGNANT WOMEN

Status
Completed
Phase
Study type
Observational
Enrollment
82 (actual)
Sponsor
Cairo University · Academic / Other
Sex
Female
Age
18 Years – 44 Years
Healthy volunteers
Not accepted

Summary

Diabetic and hypertensive pregnant women attending at Kasr Alani for antenatal care were subjected to Complete History taking. All the participants were scanned using B mode sonography to determine the fetal biometric parameters (BPD, HC, AC and FL).Only umbilical artery pulsatility index (UAPI) and pulmonary vein pulsatility index (PVPI) were measured in the study. UAPI and PVPI were measured between 28 and 34 weeks of gestation at the first routine ultrasound scheduled.

Detailed description

Diabetic and hypertensive pregnant women attending at Kasr Alani for antenatal care were subjected to Complete History taking. All the participants were scanned using B mode sonography to determine the fetal biometric parameters (BPD, HC, AC and FL).Only umbilical artery pulsatility index (UAPI) and pulmonary vein pulsatility index (PVPI) were measured in the study. UAPI and PVPI were measured between 28 and 34 weeks of gestation at the first routine ultrasound scheduled. The umbilical artery Doppler examinations were conducted on a free-floating loop at the middle of the cord, away from its placenta and fetal abdominal insertion sites. The Doppler angle was \<60°, for an optimal Doppler signal. The recording was done when fetal breathing movement or uterine contraction was absent. The Doppler wall filter was set at 50 - 100Hz, spectral peak average intensities were below 100 m/wcm2, and pulsed Doppler sample gate size was 2 mm (Adedo et al., 2022). The following umbilical artery Doppler indices (UADI) were calculated automatically by the machine: Peak Systolic Velocity (PSV) in cm/s, End Diastolic Velocity (EDV) in cm/s, Pulsatility Index (PI), Resistive Index (RI), and Systolic/Diastolic Ratio (S/D Ratio). The umbilical artery waveform pattern was also analyzed and classified into: normal diastolic flow, reduced diastolic flow, absent diastolic flow and reversed diastolic flow. The values of UAPI considered abnormal if \>95th percentile are as follows: at 28th Wk. \> 1.35, 29th Wk. \>1.32, 30th Wk. \>1.29, 31stWk \>1.27, 32ndWk. \>1.25, 33thWk \>1.22 and 34th Wk \>1.2 (Adedo et al., 2022).

Conditions

Interventions

TypeNameDescription
DIAGNOSTIC_TESTUltrasoundAll the participants were scanned using B mode sonography to determine the fetal biometric parameters (BPD, HC, AC and FL). The machine automatically calculated the estimated fetal weight using the Headlock formula. umbilical artery pulsatility index (UAPI) and pulmonary vein pulsatility index (PVPI) were measured in the study

Timeline

Start date
2024-07-01
Primary completion
2025-04-15
Completion
2025-05-12
First posted
2025-05-23
Last updated
2025-05-23

Locations

1 site across 1 country: Egypt

Source: ClinicalTrials.gov record NCT06988436. Inclusion in this directory is not an endorsement.