An observational study in Pregnancy Diabetic, sponsored by Assiut University. Not yet recruiting. Open to female participants, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-16.
Sponsored by Assiut University · Observational
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.
877 studies on the registry are indexed under Diabetes, Gestational; 203 are open to participants now.
This study's planned enrollment of 69 is below the median of 180 across 289 observational studies indexed under Diabetes, Gestational.
Browse Diabetes, Gestational studies →Assiut University is the lead sponsor of 5,078 studies on the registry; 2,178 are open to participants now.
Of its 14 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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Participants will be divided into three primary arms:
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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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• 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
Time frame: >34wks to delivery
No study locations are listed for this record.
Start is estimated for Sep 2026; primary completion for Sep 2028, 24 months later.
Of 142 non-industry observational studies under Diabetes, Gestational, half reached primary completion within 43 months of starting (the median), counting those still running; a quarter within 19 and three quarters within 70. This study's planned 24 months is below that.
Counting every sponsor, half of 144 studies reached it within 43 months; a quarter within 19 and three quarters within 73.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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