Fetal Growth RestrictionNCT07760194
Evaluation of Fetal Heart
An observational study of Fetal Growth Restriction, run by Assiut University at 1 site in Egypt.
Trial summary
Evaluation of fetal cardiac functions in cases complicated with growth restriction Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Fetal Growth Restriction
- What is being tested?
- Echocardiography
- Type of treatment
- Surgery or procedure
- How many people
- 28 participants
- Where
- 1 siteEgypt
- Study dates
- Aug 2026to Sep 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Fetuses with IUGR will be included in group 1. Fetuses with normal growth will be included in group 2.
Who may be able to join
- pregnant women
- more than 28 weehs gestation
Who cannot join
- intrauterine fetal death
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Women's Health Hospital
Asyut
Women Hospital, 0882414916, ethics_committee12@yahoo.com
About this study
Official title: Evaluation of Systolic and Diastolic Cardiac Functions in Fetuses With IUGR
Evaluation of fetal cardiac functions in cases complicated with growth restriction
Read the detailed description
10% of pregnancies are, by the description, affected by the common obstetric issue known as intrauterine growth restriction (IUGR). IUGR is a significant contributor to prenatal mortality and morbidity. Cardiomyopathy is a reliable marker of the advancement of IUGR; in these babies, it begins during the early phases of fetal growth restriction and worsens as fetal impairment advances. IUGR is caused by placental dysfunction and this leads to a state of chronic hypoxia and metabolic stress and redistribution of blood flow towards vital organs, such as the brain, heart and adrenal glands. This hemodynamic compensation can itself contribute to a progressive deterioration of fetal cardiac function and myocardial remodeling. The myocardial performance index (MPI), also known as the Tei index, has emerged as a promising tool for the non-invasive evaluation of global fetal cardiac function, integrating both systolic and diastolic performance. To overcome some of the reproducibility-related limitations of the original technique, a modified version of the MPI (Mod-MPI) was introduced, which uses the opening and closing 'clicks' of the heart valves as more precise temporal landmarks. In recent years, numerous studies have investigated the role of MPI in the assessment of IUGR fetuses, and have suggested that this index may be altered early in gestation in response to chronic hypoxia and hemodynamic stress.
- Conditions
- Fetal Growth Restriction
- Being tested
- Echocardiography
- Keywords
- Fetal heart, Echocardiography, IUGR
- Medical subject headings
- Fetal Growth Retardation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EchocardiographyProcedure or surgery
Modified MPI is obtained by placing the Doppler sample volume on the medial wall of the ascending aorta including the AV and MV, hence the movements of both valves are recorded simultaneously in the Doppler spectrum through measurements of the isovolumetric contraction time (ICT), isovolumetric relaxation time (IRT) and ejection time (ET). The isovolumetric contraction time (ICT) was measured from the closure of the MV to the opening of the AV, the ejection time (ET) from the opening to the closure of the AV, and the isovolumetric relaxation time (IRT) from the closure of the AV to the opening of the MV. The MPI (Tei index) was calculated using the following equation: MPI= (ICT + IRT)/ET
| Study group | Role | What they receive |
|---|---|---|
| Cases with IUGR | Fetal weight less than 10th percentile Receives: Procedure: Echocardiography | |
| Cases with normal growth | Fetal weight between 10th and 90th percentile Receives: Procedure: Echocardiography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurement of MPI
Increased MPI means bad outcome
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2026
- Study startAug 2026 (estimated)
- Primary completionSep 2026 (estimated)
- Study completionSep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fetal Growth RestrictionStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 28 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Gamal M.fekry, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07760194
- Sponsor's protocol ID
- MPI
- Status last verified
- Aug 2026
- First submitted
- 7 Aug 2026
- Last updated
- 13 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Systolic and Diastolic Cardiac Functions in Fetuses With IUGR
- ClinicalTrials.gov ID
- NCT07760194
- Acronym / sponsor ID
- MPI
- Conditions
- Fetal Growth Restriction
- Keywords
- Fetal heart, Echocardiography, IUGR
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 28 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Aug 2026 (estimated)
- Primary completion
- Sep 2026 (estimated)
- Study completion
- Sep 2026 (estimated)
- First posted
- 12 Aug 2026 (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.
Evaluation of fetal cardiac functions in cases complicated with growth restriction
Detailed description
10% of pregnancies are, by the description, affected by the common obstetric issue known as intrauterine growth restriction (IUGR). IUGR is a significant contributor to prenatal mortality and morbidity. Cardiomyopathy is a reliable marker of the advancement of IUGR; in these babies, it begins during the early phases of fetal growth restriction and worsens as fetal impairment advances. IUGR is caused by placental dysfunction and this leads to a state of chronic hypoxia and metabolic stress and redistribution of blood flow towards vital organs, such as the brain, heart and adrenal glands. This hemodynamic compensation can itself contribute to a progressive deterioration of fetal cardiac function and myocardial remodeling. The myocardial performance index (MPI), also known as the Tei index, has emerged as a promising tool for the non-invasive evaluation of global fetal cardiac function, integrating both systolic and diastolic performance. To overcome some of the reproducibility-related limitations of the original technique, a modified version of the MPI (Mod-MPI) was introduced, which uses the opening and closing 'clicks' of the heart valves as more precise temporal landmarks. In recent years, numerous studies have investigated the role of MPI in the assessment of IUGR fetuses, and have suggested that this index may be altered early in gestation in response to chronic hypoxia and hemodynamic stress.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cases with IUGR | – | Procedure: EchocardiographyFetal weight less than 10th percentile |
| Cases with normal growth | – | Procedure: EchocardiographyFetal weight between 10th and 90th percentile |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Fetuses with IUGR will be included in group 1. Fetuses with normal growth will be included in group 2.
Key inclusion criteria (2 listed)
- pregnant women
- more than 28 weehs gestation
Key exclusion criteria (1 listed)
- intrauterine fetal death
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 |
|---|---|---|
| EchocardiographyModified MPI is obtained by placing the Doppler sample volume on the medial wall of the ascending aorta including the AV and MV, hence the movements of both valves are recorded simultaneously in the Doppler spectrum through measurements of the isovolumetric contraction time (ICT), isovolumetric relaxation time (IRT) and ejection time (ET). The isovolumetric contraction time (ICT) was measured from the closure of the MV to the opening of the AV, the ejection time (ET) from the opening to the closure of the AV, and the isovolumetric relaxation time (IRT) from the closure of the AV to the opening of the MV. The MPI (Tei index) was calculated using the following equation: MPI= (ICT + IRT)/ET | Procedure or surgery | Cases with IUGR, Cases with normal growth |
Primary outcome
Measurement of MPI
Time frame: 2 weeks
Increased MPI means bad outcome
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2026.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Fetal Growth Restriction, 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 2 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 13 Aug 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mohamed Fekry (+20882312388, mohamedbeethoven2040@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measurement of MPI (time frame: 2 weeks). 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 13 Aug 2026.