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Cardiovascular Changes in Infants of Preeclampsia Mother

Cardiovascular Changes in the Infants of Mothers With Preeclampsia and Factors Associated With Neonatal Outcomes

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04699825
Enrollment
20
Registered
2021-01-07
Start date
2021-04-01
Completion date
2022-10-01
Last updated
2021-01-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pre-Eclampsia

Brief summary

Preeclampsia (hypertension during pregnancy) is a common problem affecting 2-8% of pregnancies worldwide and is typically diagnosed by increased blood pressure and proteinuria. The rate of preeclampsia has increased since the 1980s with higher rates at extreme maternal ages as well as during the first pregnancy. Pre-eclampsia is a serious hypertensive disorder of pregnancy affecting outcomes for both mother and infants. These infants not only have increased risk of neonatal complications including preterm birth, intrauterine growth restriction, abnormal Doppler parameters, feed intolerance, intestinal problem, poor growth, and long term lung condition but also have increased risk of cerebral palsy, abnormal neurodevelopmental outcomes, cardiovascular disease, stroke, and mental disorders during childhood and adulthood.

Detailed description

Preeclampsia is diagnosed according to the International Society for the Study of Hypertension in Pregnancy (ISSHP) criteria: BP \> 140/90 on two occasions in previous normotensive mother after 20 weeks of gestation and one of the following; proteinuria in urine \> 0.3 gram/kg/day or acute kidney or liver dysfunction or signs of uterine dysfunction. The onset of preeclampsia can be early before 34 weeks of pregnancy (Early-onset preeclampsia) or late after 34 weeks of pregnancy (Late-onset preeclampsia). Early-onset preeclampsia, especially between 28-32 weeks gestation, is characterized by a high prevalence of microvascular changes in the placenta that makes mothers and their infants are more liable to complication. The pathogenesis of preeclampsia is unclear. Preeclampsia affects hematopoiesis and the fetal myeloid lineage leading to thrombocytopenia, neutropenia, decrease phagocytic function, decrease T regulatory cells, and an increase in cytotoxic natural killer cells in neonates. Innate and adaptive immunity are regulated by myeloid cells and the immune changes in infants of preeclampsia mothers could lead to increased incidence of neonatal sepsis and the development of chronic inflammatory conditions.

Interventions

OTHERCardiovascular and immunological changes

performing cardiac ultrasound, vascular doppler, and immunological study on cord blood sample

Sponsors

Assiut University
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE

Intervention model description

enrollment of infants born from preeclampsia mother and control from infants born from normal pregnancies

Eligibility

Sex/Gender
ALL
Age
1 Minutes to 3 Days
Healthy volunteers
No

Inclusion criteria

* Infants born from Pregnant women with preeclampsia, their mother willing to give consent.

Exclusion criteria

* 1-Infant with a major heart problem. * Infants with major congenital and genetic anomalies.

Design outcomes

Primary

MeasureTime frameDescription
Cardiac changeswithin 72 hours after birthcardiac output will be presented by ml/minute
Cardiac function changeswithin 72 hours after birthFractional shortening and ejection fraction will be presented by percentage
Vascular changes in superior mesenteric and anterior cerebral arteries72 hours after birthDoppler parameters( peak-systolic velocity, end-diastolic velocity, and mean velocity. All will be measured in meter/second

Secondary

MeasureTime frameDescription
Feeding problem3 months after birthrate of necrotizing enterocolitis and feeding intolerance
oval all outcomes3 monthsRate of long term lung condition, sepsis, intraventricular hemorrhage and overall mortality
immunological changescord blood at birthinterleukins level

Contacts

Primary ContactAhmed S Ali
ahmedsalehali@aun.edu.eg7309405405

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026