- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT07811050
Predictive Value of Fetal Modified Myocardial Performance Index for Adverse Perinatal Outcomes in Late Onset Preeclampsia and Diabetes Mellitus
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.
Studieoversikt
Status
Forhold
Studietype
Registrering (Antatt)
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Barn
- Voksen
- Eldre voksen
Tar imot friske frivillige
Prøvetakingsmetode
Studiepopulasjon
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.
Beskrivelse
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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Studieplan
Hvordan er studiet utformet?
Designdetaljer
Kohorter og intervensjoner
Gruppe / Kohort |
|---|
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svangerskapsforgiftning
|
|
Healthy pregnancies
|
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Pregnancy Diabetic
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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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.
Tidsramme: >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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Samarbeidspartnere og etterforskere
Sponsor
Publikasjoner og nyttige lenker
Hjelpsomme linker
Studierekorddatoer
Studer hoveddatoer
Studiestart (Antatt)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- AssiutS
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