Cardiovascular Changes in Infants of Preeclampsia Mother

Assiut University

Status: Unknown

Conditions: Pre-Eclampsia

Treatments: Other: Cardiovascular and immunological changes

Study type: Interventional

Funder types: Other

Identifiers

NCT04699825

cardiovascularpreeclampsia

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20 estimated patients

Sex: All

Ages: 1 minute to 3 days old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

20 participants in 2 patient groups

study group

Active Comparator group

Description:

new-born infants born from preeclampsia mother

Treatment:

Other: Cardiovascular and immunological changes

control group

Other group

Description:

new-born infants born from mothers with normal pregnancy matched with the same gestational age, sex and race

Treatment:

Other: Cardiovascular and immunological changes