Fetal HypoxiaNCT03146507
Assessment of Cardiac Sparing in Fetal Hypoxia
A study testing Ultrasound, Doppler ultrasound and Fetal echocardiography in people with Fetal Hypoxia, run by Assiut University at 1 site in Egypt.
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 . Read more about this study
- Who is it for?
- Ages 20 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Fetal Hypoxia
- What is being tested?
- Ultrasound, Doppler ultrasound and Fetal echocardiography
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 210 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Aug 2017to 1 Sep 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 35 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read more
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
- Being tested
- Ultrasound, Doppler ultrasound, Fetal echocardiography
- Medical subject headings
- Fetal Hypoxia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UltrasoundRadiation
ultrasound assessment of gestational age, amniotic fluid index, and fetal weight
Doppler ultrasoundRadiation
Umbilical artery and Middle cerebral artery Doppler blood flow assesment
Fetal echocardiographyRadiation
The cardiac output (ratio between right side cardiac outputs to left side cardiac output) was calculated
| Study group | Role | What they receive |
|---|---|---|
| Normal pregnant women at 32-34 weeks group | Other | Not described Receives: Radiation: Ultrasound; Radiation: Doppler ultrasound; Radiation: Fetal echocardiography |
| Intrauterine growth restriction at 32-34 weeks group | Other | Not described Receives: Radiation: Ultrasound; Radiation: Doppler ultrasound; Radiation: Fetal echocardiography |
What is being measured
The primary outcome is the main question the study is designed to answer.
The relative cardiac output ratio (ratio between right side cardiac outputs to left side) cardiac output) at 32-34 weeks.
Measured: 1 month
Secondary outcomes (6)
The relative cardiac output ratio at 34-36 weeks.
Measured: 1 month
The pulsatility index in the umbilical artery and middle cerebral artery at 32-34 weeks
Measured: 1 month
The pulsatility index in the umbilical artery and middle cerebral artery at 34-36 weeks
Measured: 1 month
Middle cerebral artery pulsatility index to umbilical artery pulsatility index ratio
Measured: 15 minutes
Time of delivery (weeks)
Measured: 7 weeks
Birth weight (grams)
Measured: 7 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2017
- Study start1 Aug 2017
- Primary completion1 May 2022
- Study completion1 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fetal HypoxiaStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 210 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sief el eslam Ahmed Ali, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03146507
- Sponsor's protocol ID
- AU03
- Status last verified
- Nov 2022
- First submitted
- 7 May 2017
- Last updated
- 30 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Doppler Echocardiography Assessment of Cardiac Sparing Effect in Fetal Hypoxia
- ClinicalTrials.gov ID
- NCT03146507
- Acronym / sponsor ID
- AU03
- Conditions
- Fetal Hypoxia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 210 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Aug 2017 (actual)
- Primary completion
- 1 May 2022 (actual)
- Study completion
- 1 Sep 2022 (actual)
- First posted
- 10 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 20 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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).
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ultrasoundultrasound assessment of gestational age, amniotic fluid index, and fetal weight | Radiation | Intrauterine growth restriction at 32-34 weeks group, Normal pregnant women at 32-34 weeks group |
| Doppler ultrasoundUmbilical artery and Middle cerebral artery Doppler blood flow assesment | Radiation | Intrauterine growth restriction at 32-34 weeks group, Normal pregnant women at 32-34 weeks group |
| Fetal echocardiographyThe cardiac output (ratio between right side cardiac outputs to left side cardiac output) was calculated | Radiation | Intrauterine growth restriction at 32-34 weeks group, Normal pregnant women at 32-34 weeks group |
Primary outcome
The relative cardiac output ratio (ratio between right side cardiac outputs to left side) cardiac output) at 32-34 weeks.
Time frame: 1 month
6 secondary outcomes
The relative cardiac output ratio at 34-36 weeks.
Time frame: 1 month
The pulsatility index in the umbilical artery and middle cerebral artery at 32-34 weeks
Time frame: 1 month
The pulsatility index in the umbilical artery and middle cerebral artery at 34-36 weeks
Time frame: 1 month
Middle cerebral artery pulsatility index to umbilical artery pulsatility index ratio
Time frame: 15 minutes
Time of delivery (weeks)
Time frame: 7 weeks
Birth weight (grams)
Time frame: 7 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Nov 2022.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ultrasound, Doppler ultrasound and Fetal echocardiography in people with Fetal Hypoxia, run by Assiut University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The relative cardiac output ratio (ratio between right side cardiac outputs to left side) cardiac output) at 32-34 weeks. (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Nov 2022.