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CompletedNCT03265704MPIHHPNUpdated Aug 29, 2017

Maternal High Blood Pressure and Newborn's Blood Profile

An observational study in Maternal-Fetal Exchange, sponsored by Romanian Society of Anesthesia and Intensive Care. Completed at 1 site in Romania. Open to participants aged 1 Day to 28 Days. Per ClinicalTrials.gov, last updated 2017-08-29.

Sponsored by Romanian Society of Anesthesia and Intensive Care · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
6,108
Ages
1 Day to 28 Days
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Maternal-Fetal Exchange

Keywords

  • Maternal PIH
  • Neonatal thrombocytopenia
  • Neonatal neutropenia
03

Who can participate

Ages eligible
1 Day to 28 Days
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

All newborns admitted to the Neonatology Department who met the Inclusion 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

Exclusion Criteria:

  • Maternal disease other than PIH;
  • Syndromal, chromosomal or infectious diseases of the newborns;
  • Causes other then PIH for perinatal asphyxia.
04

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
6,108 participants (actual)
Patient registry
No

Groups and cohorts

  • 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

  • OtherAGA - Control group

    Data processing from Patient Medical Files

  • OtherSGA - Control group

    Data processing from Patient Medical Files

  • OtherAGA-PIH Study group

    Monitoring PIH-related changes in the newborn

  • OtherSGA-PIH Study group

    Monitoring PIH-related changes in the newborn

05

What researchers measure

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.

    Time frame: Blood profiles of newborns aged between 1-28 days were evaluated.

06

Study locations

1 site
  • Romanian Society of Anesthesia and Intensive Care
    Timisoara, Romania
07

References and documents

Publications

  • 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. PubMed 18759083 ↗
  • 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. PubMed 21547086 ↗
  • 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. PubMed 9215266 ↗
  • 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. PubMed 26459642 ↗

Individual participant data

Plan to share: No

08

Registry details

Key details

Study ID
NCT03265704
Lead sponsor
Romanian Society of Anesthesia and Intensive Care
Collaborators
University of Medicine and Pharmacy "Victor Babes" Timisoara, Timişoara County Emergency Clinical Hospital
Responsible party
Alexandru Florin Rogobete (MSc, PhDs, Clinical Researcher, Romanian Society of Anesthesia and Intensive Care) — Principal investigator
First posted
Aug 29, 2017
Start date
Jan 1, 2016
Primary completion
Aug 25, 2017
Completion
Aug 25, 2017
Last update
Aug 29, 2017

Study contacts

Alexandru Florin Rogobete, PhDs
principal investigator · Romanian Society of Anesthesia and Intensive Care
Dorel Sandesc, Prof
study chair · Romanian Society of Anesthesia and Intensive Care
Ovidiu Bedreag, Assoc Prof
study director · Romanian Society of Anesthesia and Intensive Care

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Aug 2017. You cannot join it, but the record below documents what was studied.

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