Cardiovascular Changes in Infants of Preeclampsia Mother

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Pre-Eclampsia

Intervention / Treatment
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* Other: Cardiovascular and immunological changes


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 1 Minute
Maximum Age: 3 Days

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: enrollment of infants born from preeclampsia mother and control from infants born from normal pregnancies
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: study group<br>new-born infants born from preeclampsia mother | Other: Cardiovascular and immunological changes<br>* performing cardiac ultrasound, vascular doppler, and immunological study on cord blood sample<br>|
| Other: control group<br>new-born infants born from mothers with normal pregnancy matched with the same gestational age, sex and race | Other: Cardiovascular and immunological changes<br>* performing cardiac ultrasound, vascular doppler, and immunological study on cord blood sample<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cardiac changes | cardiac output will be presented by ml/minute | within 72 hours after birth | 
| Cardiac function changes | Fractional shortening and ejection fraction will be presented by percentage | within 72 hours after birth | 
| Vascular changes in superior mesenteric and anterior cerebral arteries | Doppler parameters( peak-systolic velocity, end-diastolic velocity, and mean velocity. All will be measured in meter/second | 72 hours after birth | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feeding problem | rate of necrotizing enterocolitis and feeding intolerance | 3 months after birth | 
| oval all outcomes | Rate of long term lung condition, sepsis, intraventricular hemorrhage and overall mortality | 3 months | 
| immunological changes | interleukins level | cord blood at birth |