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Clinical Trials/NCT03265704
NCT03265704
Completed
Not Applicable

Maternal Pregnancy Induced Hypertension and Hematological Profile of Newborns

Romanian Society of Anesthesia and Intensive Care1 site in 1 country6,108 target enrollmentJanuary 1, 2016

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Maternal-Fetal Exchange
Sponsor
Romanian Society of Anesthesia and Intensive Care
Enrollment
6108
Locations
1
Primary Endpoint
Hematological Changes in the Newborns of Mothers with Pregnancy Induced Hypertension
Status
Completed
Last Updated
8 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
January 1, 2016
End Date
August 25, 2017
Last Updated
8 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Romanian Society of Anesthesia and Intensive Care
Responsible Party
Principal Investigator
Principal Investigator

Alexandru Florin Rogobete

MSc, PhDs, Clinical Researcher

Romanian Society of Anesthesia and Intensive Care

Eligibility Criteria

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.

Outcomes

Primary Outcomes

Hematological Changes in the Newborns of Mothers with Pregnancy Induced Hypertension

Time Frame: 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.

Study Sites (1)

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