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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03515759
Recruitment Status : Completed
First Posted : May 4, 2018
Last Update Posted : February 15, 2019
Sponsor:
Information provided by (Responsible Party):
Moutaz Sherbini, Cairo University

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.


Condition or disease
Pre-Eclampsia IUGR

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Study Type : Observational
Actual Enrollment : 60 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: The Efficacy of Fetal Arterial and Venous Doppler Indices in Predicting Perinatal Outcome Among Severely Hypertensive Pregnant Patients.
Actual Study Start Date : November 1, 2017
Actual Primary Completion Date : January 15, 2019
Actual Study Completion Date : January 15, 2019

Resource links provided by the National Library of Medicine


Group/Cohort
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



Primary Outcome Measures :
  1. The diagnostic value of umbilical artery (UA) Doppler indices (RI & PI) in predicting adverse perinatal outcome among severely hypertensive patients [ Time Frame: within 24 hours before delivery and post natal ]
    sensitivity and specificity of umbilical artery RI & PI in detecting IUGR and APGAR score less than 7 at 5 minutes


Secondary Outcome Measures :
  1. The diagnostic value of Middle cerebral artery (MCA) Doppler indices (RI & PI) in predicting adverse perinatal outcome among severely hypertensive patients [ Time Frame: within 24 hours before delivery and post natal ]
    sensitivity and specificity of middle cerebral artery RI & PI in detecting IUGR and APGAR score less than 7 at 5 minutes

  2. The diagnostic value of cerebro/placentaI Ratio in predicting adverse perinatal outcome among severely hypertensive patients. [ Time Frame: within 24 hours before delivery and post natal ]
    sensitivity and specificity of of MCA/UA PI Ratio in detecting IUGR and APGAR score less than 7 at 5 minutes

  3. The diagnostic value of Ductus Venousus Doppler indices in predicting adverse perinatal outcome among severely hypertensive patients. [ Time Frame: within 24 hours before delivery and post natal ]
    sensitivity and specificity of peak velocity index (PVIV), peak systolic velocity (PSV) and abnormal A wave in detecting IUGR and APGAR score less than 7 at 5 minutes



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Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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 )

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03515759


Locations
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Egypt
Kasr Elainy Hospital (Faculty of Medicine - Cairo University)
Cairo, Egypt, 115431
Sponsors and Collaborators
Cairo University
Investigators
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Principal Investigator: moutaz elsherbini, MD Assistant professor of obstetrics and gynecology
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Responsible Party: Moutaz Sherbini, assistant professor, Cairo University
ClinicalTrials.gov Identifier: NCT03515759    
Other Study ID Numbers: 2062010
First Posted: May 4, 2018    Key Record Dates
Last Update Posted: February 15, 2019
Last Verified: April 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Moutaz Sherbini, Cairo University:
PREECLAMPSIA
DOPPLER
IUGR
UMBILICAL ARTERY
MIDDLE CEREBRAL ARTERY
Additional relevant MeSH terms:
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Eclampsia
Pre-Eclampsia
Hypertension, Pregnancy-Induced
Pregnancy Complications