Fetal Doppler Indices in Predicting Perinatal Outcome Among Severely Hypertensive Pregnant Patients.

NCT03515759 | Completed DMC

• 1 other identifier: 2062010
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

60 pregnant women with singleton living fetus between 34 -38 wks gestation known to have severe hypertension in the current pregnancy were included. All participants underwent Doppler ultrasonography to evaluate the Feto-Placental Circulation within 24 hours from Pregnancy Termination. Flow Velocity Waveforms were obtained from: Umbilical Artery (UA), Middle Cerebral Artery (MCA), Ductus Venosus (DV), Umbilical Vein (UV). From the flow velocity waveforms the following indices were measured: UA \& MCA: Pulsatility Index (PI) \& Resistance Index (RI), DV: Peak Velocity Index For veins (PVIV), Peak Systolic Velocity (PSV) \& a- wave. UV Flow: Presence or Absence of Pulsatile Flow.

Conditions

Pre-Eclampsia; IUGR

Keywords

PREECLAMPSIA; DOPPLER; IUGR; UMBILICAL ARTERY; MIDDLE CEREBRAL ARTERY

Outcome Measures

Primary Outcomes (1)

• The diagnostic value of umbilical artery (UA) Doppler indices (RI & PI) in predicting adverse perinatal outcome among severely hypertensive patients

  sensitivity and specificity of umbilical artery RI \& PI in detecting IUGR and APGAR score less than 7 at 5 minutes

  within 24 hours before delivery and post natal

Secondary Outcomes (3)

• The diagnostic value of Middle cerebral artery (MCA) Doppler indices (RI & PI) in predicting adverse perinatal outcome among severely hypertensive patients

  within 24 hours before delivery and post natal

• The diagnostic value of cerebro/placentaI Ratio in predicting adverse perinatal outcome among severely hypertensive patients.

  within 24 hours before delivery and post natal

• The diagnostic value of Ductus Venousus Doppler indices in predicting adverse perinatal outcome among severely hypertensive patients.

  within 24 hours before delivery and post natal

Study Arms (1)

hypertensive patients

60 pregnant women with singleton living fetus between 34 -38 wks gestation known to have severe hypertension in the current pregnancy were included

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

60 pregnant women with singleton living fetus between 34 -38 wks gestation known to have severe hypertension in the current pregnancy were included.

You may qualify if:

• Gestational age (GA): 34 - 38weeks of gestations (confirmed by a reliable date for the last menstrual period or /and 1st trimester ultrasound scan).
• The current Pregnancy complicated with severe hypertension (gestational hypertension, preeclampsia, chronic hypertension and chronic hypertension with superimposed preeclampsia).
• Singleton living fetus.

You may not qualify if:

• Maternal medical disorders rather than hypertension.
• Fetal congenital anomalies.
• Rupture of membrane.
• Antepartum hemorrhage (placenta previa or accidental hemorrhage).
• The maternal administration of respiratory depressants within 2 hours from the delivery of the fetus (e. g., opioid analgesic )

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Kasr Elainy Hospital (Faculty of Medicine - Cairo University)

Cairo, 115431, Egypt

Location

MeSH Terms

Conditions

Pre-Eclampsia

Condition Hierarchy (Ancestors)

Hypertension, Pregnancy-Induced; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• moutaz elsherbini, MD

  Assistant professor of obstetrics and gynecology

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: April 23, 2018
• First Posted: May 4, 2018
• Study Start: November 1, 2017
• Primary Completion: January 15, 2019
• Study Completion: January 15, 2019
• Last Updated: February 15, 2019

Record last verified: 2018-04

Locations

EG (1)