Fetal Growth RestrictionNCT07676708
Patterns of Aortic Isthmus Doppler in Early Fetal Growth Restriction , and the Changes in Aortic Isthmus Doppler Parameters With Every Changes of Other Early Iugr Parameters Like EFW, Uterine Artery Doppler, Cerebroplacental Ratio and Ductus Venosus Doppler in Comparison With Normal Group .
An observational study of Fetal Growth Restriction and Placental Insufficiency, run by Assiut University.
Trial summary
This study aims to evaluate the patterns of aortic isthmus Doppler in fetuses diagnosed with early fetal growth restriction (FGR) and to correlate these findings with the severity of FGR and other Doppler parameters. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Fetal Growth Restriction, Placental Insufficiency, Aortic Isthmus Doppler
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2026to 1 Jun 2029
- 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 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Singleton pregnant women attending the fetal medicine unit at Women's Health Hospital, Assiut University, including both fetal growth restriction cases and normal controls.
Who may be able to join
- Singleton pregnancy
- Diagnosis of fetal growth restriction (estimated fetal weight <10th percentile for gestational age)
- Written informed consent obtained from the patient
Who cannot join
- Major fetal structural anomalies, especially cardiovascular anomalies
- Multiple pregnancy (e.g., twins)
- Suspected chromosomal abnormalities or genetic syndromes
- Severe maternal comorbidities affecting Doppler results (e.g., uncontrolled diabetes, lupus)
- Uncertain gestational age
- Fetal demise before Doppler assessment
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Patterns of Aortic Isthmus Doppler in Early Fetal Growth Restriction, Cross Sectional Comparative Study
This study aims to evaluate the patterns of aortic isthmus Doppler in fetuses diagnosed with early fetal growth restriction (FGR) and to correlate these findings with the severity of FGR and other Doppler parameters.
A cross-sectional comparative observational study will be conducted on singleton pregnant women attending the fetal medicine unit at Assiut University Hospital. Participants will be divided into two groups: fetuses with FGR and normal controls.
Doppler measurements including aortic isthmus indices, uterine artery, umbilical artery, middle cerebral artery, cerebroplacental ratio, and ductus venosus will be assessed at a single time point. The study will help to clarify the clinical value of aortic isthmus Doppler in early detection and assessment of fetal compromise in FGR cases.
Read the detailed description
Fetal growth restriction (FGR) is a major contributor to perinatal morbidity and mortality and is commonly associated with placental insufficiency. Early identification of fetal compromise remains a significant clinical challenge. Doppler assessment of fetal circulation has been widely used to monitor affected fetuses, including evaluation of the umbilical artery, middle cerebral artery, and ductus venosus.
The aortic isthmus represents a critical vascular junction reflecting the balance between cerebral and placental circulation. Changes in aortic isthmus Doppler patterns may provide early insights into fetal hemodynamic adaptation and deterioration in cases of FGR.
This cross-sectional comparative observational study will be conducted at the fetal medicine unit, Women's Health Hospital, Assiut University. The study population will include singleton pregnancies diagnosed with FGR (EFW <10th percentile) and a control group of normal fetuses.
Participants will undergo a single-time Doppler assessment including fetal biometry, uterine artery PI, umbilical artery PI, middle cerebral artery PI, cerebroplacental ratio, ductus venosus PI, and aortic isthmus Doppler indices. The aortic isthmus flow will be classified based on the isthmic flow index (IFI) into five categories, reflecting progressive hemodynamic changes.
The primary objective is to determine the correlation between aortic isthmus Doppler changes and the severity of FGR based on estimated fetal weight percentiles. Secondary objectives include correlation of aortic isthmus findings with cerebroplacental ratio and ductus venosus parameters.
This study is designed as a pilot exploratory study due to limited previous data. Results are expected to enhance understanding of fetal hemodynamics and potentially improve monitoring strategies in pregnancies complicated by FGR.
- Conditions
- Fetal Growth Restriction, Placental Insufficiency, Aortic Isthmus Doppler, Cerebroplacental Ratio
- Medical subject headings
- Fetal Growth Retardation, Placental Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| FGR Group | Singleton pregnancies diagnosed with fetal growth restriction (estimated fetal weight less than the 10th percentile for gestational age), undergoing Doppler assessment including aortic isthmus and other fetal vessels. | |
| Control Group | Singleton pregnancies with normal fetal growth (estimated fetal weight above the 10th percentile), undergoing the same Doppler assessment as the FGR group for comparison. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Aortic Isthmus Pulsatility Index
Measurement of the aortic isthmus pulsatility index (PI) and its correlation with the severity of fetal growth restriction based on estimated fetal weight percentiles.
Measured: Day 1
Secondary outcomes (4)
Cerebroplacental Ratio
Measurement of cerebroplacental ratio (MCA PI / UA PI) and its correlation with aortic isthmus Doppler findings.
Measured: Day 1
Ductus Venosus Doppler
Assessment of ductus venosus pulsatility index and its relationship with aortic isthmus Doppler changes in fetal growth restriction.
Measured: Day 1
Uterine and Umbilical Artery Doppler
Evaluation of uterine artery and umbilical artery pulsatility indices and their association with aortic isthmus Doppler parameters.
Measured: Day 1
Isthmic Flow Index
Assessment of isthmic flow index (IFI) and its association with fetal hemodynamic changes in fetal growth restriction cases.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2026
- Study start1 Jul 2026 (estimated)
- Primary completion1 Jun 2028 (estimated)
- Study completion1 Jun 2029 (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
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hanna Matta louize, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07676708
- Sponsor's protocol ID
- HannaMSc-E-iugr-2026
- Status last verified
- Jun 2026
- First submitted
- 22 Jun 2026
- Last updated
- 30 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patterns of Aortic Isthmus Doppler in Early Fetal Growth Restriction, Cross Sectional Comparative Study
- ClinicalTrials.gov ID
- NCT07676708
- Acronym / sponsor ID
- HannaMSc-E-iugr-2026
- Conditions
- Fetal Growth Restriction, Placental Insufficiency, Aortic Isthmus Doppler, Cerebroplacental Ratio
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Jul 2026 (estimated)
- Primary completion
- 1 Jun 2028 (estimated)
- Study completion
- 1 Jun 2029 (estimated)
- First posted
- 30 Jun 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.
This study aims to evaluate the patterns of aortic isthmus Doppler in fetuses diagnosed with early fetal growth restriction (FGR) and to correlate these findings with the severity of FGR and other Doppler parameters.
A cross-sectional comparative observational study will be conducted on singleton pregnant women attending the fetal medicine unit at Assiut University Hospital. Participants will be divided into two groups: fetuses with FGR and normal controls.
Doppler measurements including aortic isthmus indices, uterine artery, umbilical artery, middle cerebral artery, cerebroplacental ratio, and ductus venosus will be assessed at a single time point. The study will help to clarify the clinical value of aortic isthmus Doppler in early detection and assessment of fetal compromise in FGR cases.
Detailed description
Fetal growth restriction (FGR) is a major contributor to perinatal morbidity and mortality and is commonly associated with placental insufficiency. Early identification of fetal compromise remains a significant clinical challenge. Doppler assessment of fetal circulation has been widely used to monitor affected fetuses, including evaluation of the umbilical artery, middle cerebral artery, and ductus venosus.
The aortic isthmus represents a critical vascular junction reflecting the balance between cerebral and placental circulation. Changes in aortic isthmus Doppler patterns may provide early insights into fetal hemodynamic adaptation and deterioration in cases of FGR.
This cross-sectional comparative observational study will be conducted at the fetal medicine unit, Women's Health Hospital, Assiut University. The study population will include singleton pregnancies diagnosed with FGR (EFW <10th percentile) and a control group of normal fetuses.
Participants will undergo a single-time Doppler assessment including fetal biometry, uterine artery PI, umbilical artery PI, middle cerebral artery PI, cerebroplacental ratio, ductus venosus PI, and aortic isthmus Doppler indices. The aortic isthmus flow will be classified based on the isthmic flow index (IFI) into five categories, reflecting progressive hemodynamic changes.
The primary objective is to determine the correlation between aortic isthmus Doppler changes and the severity of FGR based on estimated fetal weight percentiles. Secondary objectives include correlation of aortic isthmus findings with cerebroplacental ratio and ductus venosus parameters.
This study is designed as a pilot exploratory study due to limited previous data. Results are expected to enhance understanding of fetal hemodynamics and potentially improve monitoring strategies in pregnancies complicated by FGR.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| FGR Group | – | –Singleton pregnancies diagnosed with fetal growth restriction (estimated fetal weight less than the 10th percentile for gestational age), undergoing Doppler assessment including aortic isthmus and other fetal vessels. |
| Control Group | – | –Singleton pregnancies with normal fetal growth (estimated fetal weight above the 10th percentile), undergoing the same Doppler assessment as the FGR group for comparison. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Singleton pregnant women attending the fetal medicine unit at Women's Health Hospital, Assiut University, including both fetal growth restriction cases and normal controls.
Key inclusion criteria (3 listed)
- Singleton pregnancy
- Diagnosis of fetal growth restriction (estimated fetal weight <10th percentile for gestational age)
- Written informed consent obtained from the patient
Key exclusion criteria (6 listed)
- Major fetal structural anomalies, especially cardiovascular anomalies
- Multiple pregnancy (e.g., twins)
- Suspected chromosomal abnormalities or genetic syndromes
- Severe maternal comorbidities affecting Doppler results (e.g., uncontrolled diabetes, lupus)
- Uncertain gestational age
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Aortic Isthmus Pulsatility Index
Time frame: Day 1
Measurement of the aortic isthmus pulsatility index (PI) and its correlation with the severity of fetal growth restriction based on estimated fetal weight percentiles.
4 secondary outcomes
Cerebroplacental Ratio
Time frame: Day 1
Ductus Venosus Doppler
Time frame: Day 1
Uterine and Umbilical Artery Doppler
Time frame: Day 1
Isthmic Flow Index
Time frame: 1 day
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 30 Jun 2026.
- Individual participant dataSharing planned: No
Related trials for Fetal Growth Restriction
RecruitingObservational study
Growing Little PEAPODS Study
Premature Birth, Premature Infant
Recruiting
STV Analysis Versus Visual Evaluation of Cardiotocography in FGR
Fetal Growth Retardation
RecruitingPhase 2
Statin Intervention for Severe Early-Onset Placental Insufficiency. (STATIN-PRE Trial)
Preeclampsia (PE), Intrauterine Growth Restriction (IUGR)
RecruitingObservational study
Natural History of Craniofacial Anomalies and Developmental Growth Variants
Prognathism, Retrognathism
RecruitingObservational study
Primordial Dwarfism Registry
MOPDII, Meier-Gorlin Syndrome
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.
Questions about this trial
What is this clinical trial studying?
An observational study of Fetal Growth Restriction and Placental Insufficiency, run by Assiut University.
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 3 inclusion and 6 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: opening soon, as of the sponsor's last update on 30 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
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 Hanna Matt Louize, Specialist (+201287618565, hanna.matta0155@med.aun.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Aortic Isthmus Pulsatility Index (time frame: Day 1). 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 Jun 2026.