Maternal High Blood Pressure and Newborn's Blood Profile

NCT ID: NCT03265704

Last Updated: 2017-08-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

6108 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-01-01

Study Completion Date

2017-08-25

Brief Summary

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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

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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.

Conditions

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Maternal-Fetal Exchange

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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AGA Neonates

AGA Control Group Appropriate for gestational age newborns of healthy mothers

AGA - Control group

Intervention Type OTHER

Data processing from Patient Medical Files

SGA Neonates

SGA - Control Group Small for gestational age newborns of healthy mothers

SGA - Control group

Intervention Type OTHER

Data processing from Patient Medical Files

AGA-PIH Neonates

AGA-PIH Study Group Appropriate for gestational age newborns of mothers with pregnancy induced hypertension

AGA-PIH Study group

Intervention Type OTHER

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

SGA-PIH Study group

Intervention Type OTHER

Monitoring PIH-related changes in the newborn

Interventions

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AGA - Control group

Data processing from Patient Medical Files

Intervention Type OTHER

SGA - Control group

Data processing from Patient Medical Files

Intervention Type OTHER

AGA-PIH Study group

Monitoring PIH-related changes in the newborn

Intervention Type OTHER

SGA-PIH Study group

Monitoring PIH-related changes in the newborn

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

1 Day

Maximum Eligible Age

28 Days

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Medicine and Pharmacy "Victor Babes" Timisoara

OTHER

Sponsor Role collaborator

Timişoara County Emergency Clinical Hospital

OTHER

Sponsor Role collaborator

Romanian Society of Anesthesia and Intensive Care

OTHER

Sponsor Role lead

Responsible Party

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Alexandru Florin Rogobete

MSc, PhDs, Clinical Researcher

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Alexandru Florin Rogobete, PhDs

Role: PRINCIPAL_INVESTIGATOR

Romanian Society of Anesthesia and Intensive Care

Dorel Sandesc, Prof

Role: STUDY_CHAIR

Romanian Society of Anesthesia and Intensive Care

Ovidiu Bedreag, Assoc Prof

Role: STUDY_DIRECTOR

Romanian Society of Anesthesia and Intensive Care

Locations

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Romanian Society of Anesthesia and Intensive Care

Timișoara, , Romania

Site Status

Countries

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Romania

References

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Bhat YR, Cherian CS. Neonatal thrombocytopenia associated with maternal pregnancy induced hypertension. Indian J Pediatr. 2008 Jun;75(6):571-3. doi: 10.1007/s12098-008-0110-x. Epub 2008 Aug 31.

Reference Type BACKGROUND
PMID: 18759083 (View on PubMed)

Backes CH, Markham K, Moorehead P, Cordero L, Nankervis CA, Giannone PJ. Maternal preeclampsia and neonatal outcomes. J Pregnancy. 2011;2011:214365. doi: 10.1155/2011/214365. Epub 2011 Apr 4.

Reference Type BACKGROUND
PMID: 21547086 (View on PubMed)

de Zegher F, Francois I, van Helvoirt M, Van den Berghe G. Clinical review 89: Small as fetus and short as child: from endogenous to exogenous growth hormone. J Clin Endocrinol Metab. 1997 Jul;82(7):2021-6. doi: 10.1210/jcem.82.7.4007. No abstract available.

Reference Type BACKGROUND
PMID: 9215266 (View on PubMed)

Christensen RD, Yoder BA, Baer VL, Snow GL, Butler A. Early-Onset Neutropenia in Small-for-Gestational-Age Infants. Pediatrics. 2015 Nov;136(5):e1259-67. doi: 10.1542/peds.2015-1638. Epub 2015 Oct 12.

Reference Type BACKGROUND
PMID: 26459642 (View on PubMed)

Other Identifiers

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201601MP

Identifier Type: -

Identifier Source: org_study_id

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