Assessment of Cardiac Sparing in Fetal Hypoxia

Doppler Echocardiography Assessment of Cardiac Sparing Effect in Fetal Hypoxia

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).

Study Overview

• Status: Completed
• Conditions: Fetal Hypoxia
• Intervention / Treatment: Radiation: Ultrasound; Radiation: Doppler ultrasound; Radiation: Fetal echocardiography

• Study Type: Interventional
• Enrollment (Actual): 210
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Assiut, Egypt
    • Advanced Fetal Cair Unit - Assiut University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 35 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

1. Women aged 20-35 years.
2. Women with BMI from 20-30 kg/m2.
3. Pregnant women in singleton fetuses from 32 to 34 weeks gestation.
4. 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).
5. Normal pregnant women (control group).

Exclusion Criteria:

1. Women with estimated fetal weight below the 5th or 3rd percentile.
2. Women with premature pre-labor rupture of membranes.
3. Women with antepartum hemorrhage
4. Women with fetal congenital anomalies.
5. Women with absent or reversed diastolic flow in the umbilical artery at the time of recruitment.
6. Women with preeclampsia or on anti-coagulant thereby.
7. Women who refused to participate in our study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: DIAGNOSTIC
• Allocation: NON_RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
OTHER: Normal pregnant women at 32-34 weeks group	Radiation: Ultrasound; ultrasound assessment of gestational age, amniotic fluid index, and fetal weight; Radiation: Doppler ultrasound; Umbilical artery and Middle cerebral artery Doppler blood flow assesment; Radiation: Fetal echocardiography; The cardiac output (ratio between right side cardiac outputs to left side cardiac output) was calculated
OTHER: Intrauterine growth restriction at 32-34 weeks group	Radiation: Ultrasound; ultrasound assessment of gestational age, amniotic fluid index, and fetal weight; Radiation: Doppler ultrasound; Umbilical artery and Middle cerebral artery Doppler blood flow assesment; Radiation: Fetal echocardiography; The cardiac output (ratio between right side cardiac outputs to left side cardiac output) was calculated

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
The relative cardiac output ratio (ratio between right side cardiac outputs to left side) cardiac output) at 32-34 weeks.	1 month

Secondary Outcome Measures

Outcome Measure	Time Frame
The relative cardiac output ratio at 34-36 weeks.	1 month
The pulsatility index in the umbilical artery and middle cerebral artery at 32-34 weeks	1 month
The pulsatility index in the umbilical artery and middle cerebral artery at 34-36 weeks	1 month
Middle cerebral artery pulsatility index to umbilical artery pulsatility index ratio	15 minutes
Time of delivery (weeks)	7 weeks
Birth weight (grams)	7 weeks

Collaborators and Investigators

• Sponsor: Assiut University

Study record dates

Study Major Dates

• Study Start (ACTUAL): August 1, 2017
• Primary Completion (ACTUAL): May 1, 2022
• Study Completion (ACTUAL): September 1, 2022

Study Registration Dates

• First Submitted: May 7, 2017
• First Submitted That Met QC Criteria: May 7, 2017
• First Posted (ACTUAL): May 10, 2017

Study Record Updates

• Last Update Posted (ACTUAL): November 30, 2022
• Last Update Submitted That Met QC Criteria: November 26, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Signs and Symptoms, Respiratory; Fetal Diseases; Pregnancy Complications; Hypoxia; Fetal Hypoxia
• Other Study ID Numbers: AU03

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No