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Completed

NCT Number: NCT06988436

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

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.

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Key information

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Pregnant women between 18 and 44 years.
  • Gestational age: 28 - 34 weeks of gestation at time of examination (only women with confirmed GA by sure LMP and/or first trimester US scan).
  • Singleton pregnancy.
  • Hypertensive women (preexisting or gestational hypertension).
  • Diabetic women (preexisting or gestational diabetes).

Exclusion criteria

  • Women with any medical disorder (apart from diabetes and hypertension).
  • Women with multiple pregnancies.
  • Women with inadequate ultrasound images (i.e., marked obesity).
  • Women with fetuses with chromosomal abnormalities or congenital anomalies and other factors that could affect fetal growth.
  • Unavailable perinatal outcome data

Treatment and study plan

Ultrasound

Diagnostic Test

All 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

Primary outcomes

  1. Prediction of fetal growth restriction

    Time frame: At time of delivery

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
May 23, 2025
Registry last updated
May 23, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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