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Completed

NCT Number: NCT03146507

Assessment of Cardiac Sparing 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).

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Key information

Age range

20 year–35 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Advanced Fetal Cair Unit - Assiut University

Asyut, Egypt

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Ultrasound

Radiation

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

Doppler ultrasound

Radiation

Umbilical artery and Middle cerebral artery Doppler blood flow assesment

Fetal echocardiography

Radiation

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

Primary outcomes

  1. 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 outcomes

  1. The relative cardiac output ratio at 34-36 weeks.

    Time frame: 1 month

  2. The pulsatility index in the umbilical artery and middle cerebral artery at 32-34 weeks

    Time frame: 1 month

  3. The pulsatility index in the umbilical artery and middle cerebral artery at 34-36 weeks

    Time frame: 1 month

  4. Middle cerebral artery pulsatility index to umbilical artery pulsatility index ratio

    Time frame: 15 minutes

  5. Time of delivery (weeks)

    Time frame: 7 weeks

  6. Birth weight (grams)

    Time frame: 7 weeks

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study title

Doppler Echocardiography Assessment of Cardiac Sparing Effect in Fetal Hypoxia

Important dates

Study start
2017
Primary completion
2022
Study completion
2022
First posted
May 10, 2017
Registry last updated
Nov 30, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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