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Assessment of Cardiac Sparing in Fetal Hypoxia

Primary Purpose

Fetal Hypoxia

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Ultrasound
Doppler ultrasound
Fetal echocardiography
Sponsored by
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Fetal Hypoxia

Eligibility Criteria

20 Years - 35 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  1. Singleton fetus with normal fetal anatomy documented on a detailed sonogram.
  2. Fetal abdominal circumference <5th percentile for gestational age.
  3. Evidence of placental insufficiency documented by an elevated umbilical artery pulsatility index (UA-PI) by reference ranges.

Exclusion Criteria:

  1. evidence of fetal infection
  2. chorioamnionitis
  3. fetal anomalies
  4. patient withdrawal from the study and/or unavailability for follow-up.

Sites / Locations

  • Advanced Fetal Cair Unit - Assiut University

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Normal pregnant women at 32-34 weeks group

Intrauterine growth restriction at 32-34 weeks group

Arm Description

Outcomes

Primary Outcome Measures

The relative cardiac output ratio (ratio between right side cardiac outputs to left side) cardiac output) at 32-34 weeks.

Secondary Outcome Measures

The relative cardiac output ratio at 34-36 weeks.
The pulsatility index in the umbilical artery and middle cerebral artery at 32-34 weeks
The pulsatility index in the umbilical artery and middle cerebral artery at 34-36 weeks
Middle cerebral artery pulsatility index to umbilical artery pulsatility index ratio
Time of delivery (weeks)
Birth weight (grams)

Full Information

First Posted
May 7, 2017
Last Updated
November 26, 2022
Sponsor
Assiut University
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1. Study Identification

Unique Protocol Identification Number
NCT03146507
Brief Title
Assessment of Cardiac Sparing in Fetal Hypoxia
Official Title
Doppler Echocardiography Assessment of Cardiac Sparing Effect in Fetal Hypoxia
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Completed
Study Start Date
August 1, 2017 (Actual)
Primary Completion Date
May 1, 2022 (Actual)
Study Completion Date
September 1, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assiut University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The fetal heart plays a central role in the adaptive mechanisms for hypoxemia and placental insufficiency. Longitudinal data on the hemodynamic sequence of the natural history of fetal growth restriction show that the umbilical artery and middle cerebral artery are the first variables to become abnormal . These arterial Doppler abnormalities are followed by abnormalities in the right cardiac diastolic indices, followed by the right cardiac systolic indices, and finally by both left diastolic and systolic cardiac indices . Preserving the left systolic function as the last variable to become abnormal ensures an adequate left ventricular output , which supplies the cerebral and coronary circulations.This defence is contingent on the fetal cardiovascular system, which in late gestation adopts strategies to decrease oxygen consumption and redistribute the cardiac output away from peripheral vascular beds and towards essential circulations, such as those perfusing the brain. Adding cardiac Doppler may improve management of the IUGR fetus(intrauterine growth retardation), Doppler ultrasound is valuable in defining the degree of cardiovascular compromise in at-risk pregnancies. The severity of fetal blood flow redistribution shows the degree of fetal adaptation and provides information on how long the pregnancy can be continued safely. The aime of the study is assessment of cardiac output redistribution in fetal hypoxia by estimating relative right to left side cardiac output wich reflect cardiac sparing in (IUGR).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fetal Hypoxia

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
210 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Normal pregnant women at 32-34 weeks group
Arm Type
Other
Arm Title
Intrauterine growth restriction at 32-34 weeks group
Arm Type
Other
Intervention Type
Radiation
Intervention Name(s)
Ultrasound
Intervention Description
ultrasound assessment of gestational age, amniotic fluid index, and fetal weight
Intervention Type
Radiation
Intervention Name(s)
Doppler ultrasound
Intervention Description
Umbilical artery and Middle cerebral artery Doppler blood flow assesment
Intervention Type
Radiation
Intervention Name(s)
Fetal echocardiography
Intervention Description
The cardiac output (ratio between right side cardiac outputs to left side cardiac output) was calculated
Primary Outcome Measure Information:
Title
The relative cardiac output ratio (ratio between right side cardiac outputs to left side) cardiac output) at 32-34 weeks.
Time Frame
1 month
Secondary Outcome Measure Information:
Title
The relative cardiac output ratio at 34-36 weeks.
Time Frame
1 month
Title
The pulsatility index in the umbilical artery and middle cerebral artery at 32-34 weeks
Time Frame
1 month
Title
The pulsatility index in the umbilical artery and middle cerebral artery at 34-36 weeks
Time Frame
1 month
Title
Middle cerebral artery pulsatility index to umbilical artery pulsatility index ratio
Time Frame
15 minutes
Title
Time of delivery (weeks)
Time Frame
7 weeks
Title
Birth weight (grams)
Time Frame
7 weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Women aged 20-35 years. Women with BMI from 20-30 kg/m2. Pregnant women in singleton fetuses from 32 to 34 weeks gestation. Women with late fetal growth restriction fetuses. It refers to an estimated fetal weight or abdominal circumference <10th centile. Those women had increased the resistant index (RI) in umbilical arteries above the 95th percentile at the time of recruitment (case group). Normal pregnant women (control group). Exclusion Criteria: Women with estimated fetal weight below the 5th or 3rd percentile. Women with premature pre-labor rupture of membranes. Women with antepartum hemorrhage Women with fetal congenital anomalies. Women with absent or reversed diastolic flow in the umbilical artery at the time of recruitment. Women with preeclampsia or on anti-coagulant thereby. Women who refused to participate in our study.
Facility Information:
Facility Name
Advanced Fetal Cair Unit - Assiut University
City
Assiut
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
Yes

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Assessment of Cardiac Sparing in Fetal Hypoxia

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