Maternal High Blood Pressure and Newborn's Blood Profile

Completed

• Conditions: Maternal-Fetal Exchange
• Interventions: Other: AGA-PIH Study group; Other: AGA - Control group; Other: SGA - Control group; Other: SGA-PIH Study group

• Registration Number: NCT03265704
• Lead Sponsor: Romanian Society of Anesthesia and Intensive Care

Brief Summary

Maternal high blood pressure remodels the intrauterine environment of the fetus by altering hormonal and cellular signaling patterns and, as a result increases the risk of fetal and neonatal mortality and morbidity. Newborns of these mothers have an increased risk of intrauterine growth restriction, premature birth and hematological abnormalities, such as thrombocytopenia, polycythemia, and neutropenia. The purpose of the article is to review neonatal thrombocytopenia and neutropenia as a consequence of maternal high blood pressure and to establish the optimal management of these cases.

Detailed Description

Pregnancy induced hypertension (PIH) and preeclampsia (preE) are caused by gestation and have an onset after 20 weeks of pregnancy. Although the exact etiology of PIH and preE remains unknown, two interconnected mechanisms have been identified to play an important role in the pathogenesis: dysfunction of the placental trophoblast and endothelial dysfunction within the maternal systemic vasculature. The endothelium has been identified as the target tissue of the disease. Endothelial alterations ultimately manifest as placental hypoxia and hypoplasia. The neonatal thrombocytopenia and neutropenia after pregnancy-induced hypertension is a result of inhibition of fetal bone marrow production of the myeloid lineage due to intrauterine hypoxic environment. This study aims to investigate the hematological profile in term and preterm infants born to mothers with preeclampsia. The current retrospective observational study was conducted at the Clinic of Obstetrics, Gynecology and Neonatology of the Emergency County Hospital, Timisoara over a period of three years, from January 2014 to December 2016. All inborn patient files were analyzed as anonymised limited data sets from archived records of the Neonatology Department.

Study Timeline

• Study Start: 2016-01-01
• Status Verified: 2017-08
• Primary Completion: 2017-08-25
• Study Completion: 2017-08-25
• Study First Submitted: 2017-08-26
• Study First Submitted QC: 2017-08-26
• Last Update Submitted: 2017-08-26
• Study First Posted: 2017-08-29
• Last Update Posted: 2017-08-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 6108

Inclusion Criteria

• Age: 0-28 days
• Newborns of healthy mothers;
• Newborns of mothers with Pregnancy Induced Hypertension;
• Inborn Patients;
• Written Informed Consent signed by legal guardian.

Exclusion Criteria

• Maternal disease other than PIH;
• Syndromal, chromosomal or infectious diseases of the newborns;
• Causes other then PIH for perinatal asphyxia.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
AGA-PIH Neonates	AGA-PIH Study group	AGA-PIH Study Group Appropriate for gestational age newborns of mothers with pregnancy induced hypertension
AGA Neonates	AGA - Control group	AGA Control Group Appropriate for gestational age newborns of healthy mothers
SGA Neonates	SGA - Control group	SGA - Control Group Small for gestational age newborns of healthy mothers
SGA-PIH Neonates	SGA-PIH Study group	SGA-PIH Study Group Small for gestational age newborns of mothers with pregnancy induced hypertension

Primary Outcome Measures

Name	Time	Method
Hematological Changes in the Newborns of Mothers with Pregnancy Induced Hypertension	Blood profiles of newborns aged between 1-28 days were evaluated.	Evaluating the impact of Maternal Pregnancy Induced Hypertension on fetal and neonatal hematopoiesis with focus on the myeloid lineage.

Trial Locations

Locations (1)

Romanian Society of Anesthesia and Intensive Care; 🇷🇴 Timisoara, Romania