Assessment of Cardiac Sparing in Fetal Hypoxia

Fetal Hypoxia Clinical Trial

Official title:

Doppler Echocardiography Assessment of Cardiac Sparing Effect in Fetal Hypoxia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03146507
• Other study ID #: AU03
• Status: Completed
• Phase: N/A
• Start date: August 1, 2017
• Est. completion date: September 1, 2022

Study information

• Verified date: November 2022
• Source: Assiut University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 210
• Est. completion date: September 1, 2022
• Est. primary completion date: May 1, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 20 Years to 35 Years

Eligibility

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.

Related Conditions & MeSH terms

• Fetal Hypoxia
• Hypoxia

Intervention

Radiation:
• Ultrasound
ultrasound assessment of gestational age, amniotic fluid index, and fetal weight
• Doppler ultrasound
Umbilical artery and Middle cerebral artery Doppler blood flow assesment
• Fetal echocardiography
The cardiac output (ratio between right side cardiac outputs to left side cardiac output) was calculated

Locations

Country	Name	City	State
Egypt	Advanced Fetal Cair Unit - Assiut University	Assiut

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The relative cardiac output ratio (ratio between right side cardiac outputs to left side) cardiac output) at 32-34 weeks.		1 month
Secondary	The relative cardiac output ratio at 34-36 weeks.		1 month
Secondary	The pulsatility index in the umbilical artery and middle cerebral artery at 32-34 weeks		1 month
Secondary	The pulsatility index in the umbilical artery and middle cerebral artery at 34-36 weeks		1 month
Secondary	Middle cerebral artery pulsatility index to umbilical artery pulsatility index ratio		15 minutes
Secondary	Time of delivery (weeks)		7 weeks
Secondary	Birth weight (grams)		7 weeks