NCT03265704

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
6,108

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2016

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 25, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 25, 2017

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

August 26, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 29, 2017

Completed
Last Updated

August 29, 2017

Status Verified

August 1, 2017

Enrollment Period

1.6 years

First QC Date

August 26, 2017

Last Update Submit

August 26, 2017

Conditions

Maternal-Fetal Exchange

Keywords

Maternal PIHNeonatal thrombocytopeniaNeonatal neutropenia

Outcome Measures

Primary Outcomes (1)

  • Hematological Changes in the Newborns of Mothers with Pregnancy Induced Hypertension

    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.

Study Arms (4)

AGA Neonates

AGA Control Group Appropriate for gestational age newborns of healthy mothers

Other: AGA - Control group

SGA Neonates

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

Other: SGA - Control group

AGA-PIH Neonates

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

Other: AGA-PIH Study group

SGA-PIH Neonates

SGA-PIH Study Group Small for gestational age newborns of mothers with pregnancy induced hypertension

Other: SGA-PIH Study group

Interventions

AGA - Control groupOTHER

Data processing from Patient Medical Files

AGA Neonates
SGA - Control groupOTHER

Data processing from Patient Medical Files

SGA Neonates
AGA-PIH Study groupOTHER

Monitoring PIH-related changes in the newborn

AGA-PIH Neonates
SGA-PIH Study groupOTHER

Monitoring PIH-related changes in the newborn

SGA-PIH Neonates

Eligibility Criteria

Age1 Day - 28 Days
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Romanian Society of Anesthesia and Intensive Care

Timișoara, Romania

Location

Related Publications (4)

  • 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.

    PMID: 18759083BACKGROUND

  • 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.

    PMID: 21547086BACKGROUND

  • 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.

    PMID: 9215266BACKGROUND

  • 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.

    PMID: 26459642BACKGROUND

MeSH Terms

Conditions

Thrombocytopenia, Neonatal Alloimmune

Condition Hierarchy (Ancestors)

ThrombocytopeniaBlood Platelet DisordersHematologic DiseasesHemic and Lymphatic DiseasesCytopeniaInfant, Newborn, DiseasesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

  • Alexandru Florin Rogobete, PhDs

    Romanian Society of Anesthesia and Intensive Care

    PRINCIPAL INVESTIGATOR

  • Dorel Sandesc, Prof

    Romanian Society of Anesthesia and Intensive Care

    STUDY CHAIR

  • Ovidiu Bedreag, Assoc Prof

    Romanian Society of Anesthesia and Intensive Care

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MSc, PhDs, Clinical Researcher

Study Record Dates

First Submitted

August 26, 2017

First Posted

August 29, 2017

Study Start

January 1, 2016

Primary Completion

August 25, 2017

Study Completion

August 25, 2017

Last Updated

August 29, 2017

Record last verified: 2017-08

Data Sharing

IPD Sharing
Will not share

Locations

RO(1)