Clinical trial NCT06988436: FETAL PULMONARY VEIN AND UMBILICAL ARTERY PULSATILITY INDICES AS PREDICTORS OF FETAL GROWTH RESTRICTION IN DIABETIC AND HYPERTENSIVE PREGNANT WOMEN
Official title: FETAL PULMONARY VEIN AND UMBILICAL ARTERY PULSATILITY INDICES AS PREDICTORS OF FETAL GROWTH RESTRICTION IN DIABETIC AND HYPERTENSIVE PREGNANT WOMEN
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Intrauterine Growth Restriction
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2025-05-23
Enrollment: 82
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 44
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Diabetic and hypertensive pregnant women attending at Kasr Alani for antenatal care with the following criteria.

Women were divided into 2 equal groups (total 82 cases):

* Group A: hypertensive group 41 patients.
* Group B: diabetic group 41 patients.

Brief 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).

Eligibility criteria: 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

Primary outcomes:
measure: Prediction of fetal growth restriction
timeFrame: At time of delivery
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Kasr Alainy medical school
Study officials:
affiliation: Cairo University
name: Ahmed Maged, MD
role: PRINCIPAL_INVESTIGATOR
References: