Maternal High Blood Pressure and Newborn's Blood Profile (MPIHHPN)

August 26, 2017 updated by: Alexandru Florin Rogobete, Romanian Society of Anesthesia and Intensive Care

Maternal Pregnancy Induced Hypertension and Hematological Profile of Newborns

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

6108

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Romania
      • Timisoara, Romania
        • Romanian Society of Anesthesia and Intensive Care

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 day to 4 weeks (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

All newborns admitted to the Neonatology Department who met the Inclusion Criteria.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
AGA Neonates
AGA Control Group Appropriate for gestational age newborns of healthy mothers
Other: AGA - Control group
Data processing from Patient Medical Files
SGA Neonates
SGA - Control Group Small for gestational age newborns of healthy mothers
Other: SGA - Control group
Data processing from Patient Medical Files
AGA-PIH Neonates
AGA-PIH Study Group Appropriate for gestational age newborns of mothers with pregnancy induced hypertension
Other: AGA-PIH Study group
Monitoring PIH-related changes in the newborn
SGA-PIH Neonates
SGA-PIH Study Group Small for gestational age newborns of mothers with pregnancy induced hypertension
Other: SGA-PIH Study group
Monitoring PIH-related changes in the newborn

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Blood profiles of newborns aged between 1-28 days were evaluated.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Romanian Society of Anesthesia and Intensive Care

Collaborators

University of Medicine and Pharmacy "Victor Babes" Timisoara
Timişoara County Emergency Clinical Hospital

Investigators

  • Study Chair: Dorel Sandesc, Prof, Romanian Society of Anesthesia and Intensive Care
  • Study Director: Ovidiu Bedreag, Assoc Prof, Romanian Society of Anesthesia and Intensive Care

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2016

Primary Completion (Actual)

August 25, 2017

Study Completion (Actual)

August 25, 2017

Study Registration Dates

First Submitted

August 26, 2017

First Submitted That Met QC Criteria

August 26, 2017

First Posted (Actual)

August 29, 2017

Study Record Updates

Last Update Posted (Actual)

August 29, 2017

Last Update Submitted That Met QC Criteria

August 26, 2017

Last Verified

August 1, 2017

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 201601MP

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Maternal-Fetal Exchange

Clinical Trials on AGA - Control group

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Saudi Arabia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe