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

NCT ID: NCT06988436

Last Updated: 2025-05-23

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 82 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-07-01
• Study Completion Date: 2025-05-12

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).

Conditions

Intrauterine Growth Restriction

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

hypertensive group

Pregnant women diagnosed with preexisting or gestational hypertension

Ultrasound

Intervention Type: 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

Diabetic group

Pregnant women diagnosed with preexisting or gestational diabetes

Ultrasound

Intervention Type: 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

Interventions

Ultrasound

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

Intervention Type: DIAGNOSTIC_TEST

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 44 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Ahmed M Maged, MD

professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ahmed Maged, MD

Role: PRINCIPAL_INVESTIGATOR

Cairo University

Locations

Kasr Alainy medical school

Cairo, , Egypt

Countries

Egypt

Other Identifiers

365

Identifier Type: -

Identifier Source: org_study_id