Assessment of Cardiac Sparing in Fetal Hypoxia

NCT03146507 | Completed

• 1 other identifier: AU03
• Study Type: interventional
• Target: 210
• Locations: 1 country
• Sites: 1

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).

Conditions

Fetal Hypoxia

Outcome Measures

Primary Outcomes (1)

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

  1 month

Secondary Outcomes (6)

• 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

Study Arms (2)

Normal pregnant women at 32-34 weeks group

OTHER

Radiation: Ultrasound; Radiation: Doppler ultrasound; Radiation: Fetal echocardiography

Intrauterine growth restriction at 32-34 weeks group

OTHER

Radiation: Ultrasound; Radiation: Doppler ultrasound; Radiation: Fetal echocardiography

Interventions

Ultrasound RADIATION

ultrasound assessment of gestational age, amniotic fluid index, and fetal weight

Intrauterine growth restriction at 32-34 weeks group; Normal pregnant women at 32-34 weeks group

Doppler ultrasound RADIATION

Umbilical artery and Middle cerebral artery Doppler blood flow assesment

Intrauterine growth restriction at 32-34 weeks group; Normal pregnant women at 32-34 weeks group

Fetal echocardiography RADIATION

The cardiac output (ratio between right side cardiac outputs to left side cardiac output) was calculated

Intrauterine growth restriction at 32-34 weeks group; Normal pregnant women at 32-34 weeks group

Eligibility Criteria

• Age: 20 Years - 35 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Advanced Fetal Cair Unit - Assiut University

Asyut, Egypt

Location

MeSH Terms

Conditions

Fetal Hypoxia

Interventions

High-Energy Shock Waves

Condition Hierarchy (Ancestors)

Fetal Diseases; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Hypoxia; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Ultrasonic Waves; Sound; Radiation, Nonionizing; Radiation; Physical Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: May 7, 2017
• First Posted: May 10, 2017
• Study Start: August 1, 2017
• Primary Completion: May 1, 2022
• Study Completion: September 1, 2022
• Last Updated: November 30, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will share

Locations

EG (1)