- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07811050
Predictive Value of Fetal Modified Myocardial Performance Index and Cerebroplacental-Uterine Ratio for Adverse Perinatal Outcomes in Late Onset Preeclampsia and Diabetes Mellitus
Predictive Value of The Modified Myocardial Performance Index and The Cerebroplacental-Uterine Ratio for Adverse Perinatal Outcomes in Late Onset Preeclampsia and Diabetes Mellitus: Prospective Cohort 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 .
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 Overview
Status
Conditions
Study Type
Enrollment (Estimated)
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Participants will be divided into three primary arms:
- Diabetes Mellitus (DM): further stratified into gestational diabetes mellitus (GDM) and pregestational diabetes mellitus.
- Preeclampsia (PET): late onset preeclampsia will included.
- Healthy Controls: Singleton pregnancies with no maternal or fetal complications.
Description
Inclusion Criteria:
- 1.pregnancy complicated diabetes mellitus (DM) group 2.Preeclampsia (PET) group. 3.Healthy control group.
Exclusion Criteria:
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
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Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
|---|
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preeclampsia
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Healthy pregnancies
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Pregnancy Diabetic
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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• 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
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Adverse events include Neonatal death Apgar score <7 at 5 min Fetal distress
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>34wks to delivery
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Collaborators and Investigators
Sponsor
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- AssiutS
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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