Pregnancy DiabeticNCT07811050
Predictive Value of Fetal Modified Myocardial Performance Index for Adverse Perinatal Outcomes in Late Onset Preeclampsia and Diabetes Mellitus
An observational study of Pregnancy Diabetic, run by Assiut University.
Trial summary
High-Risk Pregnancies complicated by gestational diabetes mellitus (GDM) and preeclampsia (PE) represent a significant global health challenge, affecting approximately 15-20% of all pregnancies. Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pregnancy Diabetic
- How many people
- 69 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2026to 30 Sep 2028
- 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: Participants will be divided into three primary arms: 1. Diabetes Mellitus (DM): further stratified into gestational diabetes mellitus (GDM) and pregestational diabetes mellitus. 2. Preeclampsia (PET): late onset preeclampsia will included. 3. Healthy Controls: Singleton pregnancies with no maternal or fetal complications.
Who may be able to join
- 1.pregnancy complicated diabetes mellitus (DM) group 2.Preeclampsia (PET) group. 3.Healthy control group.
Who cannot join
- 1. Multiple pregnancy 3.Chronic hypertension 4.Congenital fetal anomalies 5.Fetal growth restriction 6.Maternal cardiac or renal disease 7.Poor visualization during ultrasound examination
- -
About this study
High-Risk Pregnancies complicated by gestational diabetes mellitus (GDM) and preeclampsia (PE) represent a significant global health challenge, affecting approximately 15-20% of all pregnancies. These conditions are major contributors to adverse perinatal outcomes, including respiratory distress, neonatal hypoglycemia, and NICU admission. Beyond these, growing evidence suggests that the fetal heart undergoes early structural and functional adaptations to the altered intrauterine environment .
Current strategies for fetal surveillance mainly rely on conventional Doppler indices including umbilical artery, middle cerebral artery, and cerebroplacental ratio (CPR).Recently, interest has shifted toward combining cardiac functional assessment with placental Doppler parameters to improve prediction of adverse neonatal outcomes .
Read more
The Modified Myocardial Performance Index has emerged as a sensitive Doppler-derived parameter for assessment of global fetal cardiac function through evaluation of systolic and diastolic time intervals. Several studies demonstrated elevated Mod-MPI values in fetuses affected by placental insufficiency and maternal metabolic disorders reflecting early fetal cardiac dysfunction .
More recently, the cerebroplacental-uterine ratio (CPUR) has been introduced as a novel Doppler index that incorporates both fetal and maternal circulatory parameters.
Therefore, further research is needed to evaluate advanced Doppler indices , particularly the cerebroplacental-uterine ratio (CPUR) and Mod-MPI in high risk pregnancy complicated by Diabetes mellitus and preeclampsia .This may enhance early detection of fetal compromise and improve prediction of neonatal morbidity. The rationale of the present study Is based on the need for a reliable, reproducible, and clinically applicable fetal cardiac assessment tool that can complement conventional Doppler surveillance and optimize perinatal management in high-risk pregnancies.
- Conditions
- Pregnancy Diabetic
- Medical subject headings
- Diabetes, Gestational
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 |
|---|---|---|
| Healthy pregnancies | Not described | |
| preeclampsia | Not described | |
| Pregnancy Diabetic | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
• the predictive value of Fetal MOD-MPI and CPUR in pregnancies complicated by diabetes mellitus and preeclampsia to predict adverse perinatal outcomes.
Adverse events include Neonatal death Apgar score <7 at 5 min Fetal distress
Measured: >34wks to delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2026
- Study start1 Sep 2026 (estimated)
- Primary completion30 Sep 2028 (estimated)
- Study completion30 Sep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pregnancy DiabeticStudies 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
- 69 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alaa Gamal Abd El-Naser, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07811050
- Sponsor's protocol ID
- AssiutS
- Status last verified
- Sep 2026
- First submitted
- 16 Aug 2026
- Last updated
- 16 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predictive Value of Fetal Modified Myocardial Performance Index for Adverse Perinatal Outcomes in Late Onset Preeclampsia and Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT07811050
- Acronym / sponsor ID
- AssiutS
- Conditions
- Pregnancy Diabetic
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 69 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Sep 2026 (estimated)
- Primary completion
- 30 Sep 2028 (estimated)
- Study completion
- 30 Sep 2028 (estimated)
- First posted
- 9 Sep 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.
High-Risk Pregnancies complicated by gestational diabetes mellitus (GDM) and preeclampsia (PE) represent a significant global health challenge, affecting approximately 15-20% of all pregnancies. These conditions are major contributors to adverse perinatal outcomes, including respiratory distress, neonatal hypoglycemia, and NICU admission. Beyond these, growing evidence suggests that the fetal heart undergoes early structural and functional adaptations to the altered intrauterine environment .
Current strategies for fetal surveillance mainly rely on conventional Doppler indices including umbilical artery, middle cerebral artery, and cerebroplacental ratio (CPR).Recently, interest has shifted toward combining cardiac functional assessment with placental Doppler parameters to improve prediction of adverse neonatal outcomes .
The Modified Myocardial Performance Index has emerged as a sensitive Doppler-derived parameter for assessment of global fetal cardiac function through evaluation of systolic and diastolic time intervals. Several studies demonstrated elevated Mod-MPI values in fetuses affected by placental insufficiency and maternal metabolic disorders reflecting early fetal cardiac dysfunction .
More recently, the cerebroplacental-uterine ratio (CPUR) has been introduced as a novel Doppler index that incorporates both fetal and maternal circulatory parameters.
Therefore, further research is needed to evaluate advanced Doppler indices , particularly the cerebroplacental-uterine ratio (CPUR) and Mod-MPI in high risk pregnancy complicated by Diabetes mellitus and preeclampsia .This may enhance early detection of fetal compromise and improve prediction of neonatal morbidity. The rationale of the present study Is based on the need for a reliable, reproducible, and clinically applicable fetal cardiac assessment tool that can complement conventional Doppler surveillance and optimize perinatal management in high-risk pregnancies.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Healthy pregnancies | – | – |
| preeclampsia | – | – |
| Pregnancy Diabetic | – | – |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Participants will be divided into three primary arms: 1. Diabetes Mellitus (DM): further stratified into gestational diabetes mellitus (GDM) and pregestational diabetes mellitus. 2. Preeclampsia (PET): late onset preeclampsia will included. 3. Healthy Controls: Singleton pregnancies with no maternal or fetal complications.
Key inclusion criteria (1 listed)
- 1.pregnancy complicated diabetes mellitus (DM) group 2.Preeclampsia (PET) group. 3.Healthy control group.
Key exclusion criteria (2 listed)
- 1. Multiple pregnancy 3.Chronic hypertension 4.Congenital fetal anomalies 5.Fetal growth restriction 6.Maternal cardiac or renal disease 7.Poor visualization during ultrasound examination
- -
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
• the predictive value of Fetal MOD-MPI and CPUR in pregnancies complicated by diabetes mellitus and preeclampsia to predict adverse perinatal outcomes.
Time frame: >34wks to delivery
Adverse events include Neonatal death Apgar score <7 at 5 min Fetal distress
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 16 Sep 2026.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Pregnancy Diabetic, 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 1 inclusion and 2 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 16 Sep 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?
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 predictive value of Fetal MOD-MPI and CPUR in pregnancies complicated by diabetes mellitus and preeclampsia to predict adverse perinatal outcomes. (time frame: >34wks to delivery). 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 16 Sep 2026.