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

NCT06988436 | Completed DMC

• 1 other identifier: 365
• Study Type: observational
• Target: 82
• Locations: 1 country
• Sites: 1

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.

Conditions

Intrauterine Growth Restriction

Outcome Measures

Primary Outcomes (1)

• Prediction of fetal growth restriction

  At time of delivery

Study Arms (2)

hypertensive group

Pregnant women diagnosed with preexisting or gestational hypertension

Diagnostic Test: Ultrasound

Diabetic group

Pregnant women diagnosed with preexisting or gestational diabetes

Diagnostic Test: Ultrasound

Interventions

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

Diabetic group; hypertensive group

Eligibility Criteria

• Age: 18 Years - 44 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Kasr Alainy medical school

Cairo, 12111, Egypt

Location

MeSH Terms

Conditions

Fetal Growth Retardation

Interventions

Ultrasonography

Condition Hierarchy (Ancestors)

Fetal Diseases; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Growth Disorders; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Ahmed Maged, MD

  Cairo University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: May 16, 2025
• First Posted: May 23, 2025
• Study Start: July 1, 2024
• Primary Completion: April 15, 2025
• Study Completion: May 12, 2025
• Last Updated: May 23, 2025

Record last verified: 2025-05

Locations

EG (1)