<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03265704</url>
  </required_header>
  <id_info>
    <org_study_id>201601MP</org_study_id>
    <nct_id>NCT03265704</nct_id>
  </id_info>
  <brief_title>Maternal High Blood Pressure and Newborn's Blood Profile</brief_title>
  <acronym>MPIHHPN</acronym>
  <official_title>Maternal Pregnancy Induced Hypertension and Hematological Profile of Newborns</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Romanian Society of Anesthesia and Intensive Care</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of Medicine and Pharmacy &quot;Victor Babes&quot; Timisoara</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Timişoara County Emergency Clinical Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Romanian Society of Anesthesia and Intensive Care</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Maternal high blood pressure remodels the intrauterine environment of the fetus by altering&#xD;
      hormonal and cellular signaling patterns and, as a result increases the risk of fetal and&#xD;
      neonatal mortality and morbidity. Newborns of these mothers have an increased risk of&#xD;
      intrauterine growth restriction, premature birth and hematological abnormalities, such as&#xD;
      thrombocytopenia, polycythemia, and neutropenia. The purpose of the article is to review&#xD;
      neonatal thrombocytopenia and neutropenia as a consequence of maternal high blood pressure&#xD;
      and to establish the optimal management of these cases.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Pregnancy induced hypertension (PIH) and preeclampsia (preE) are caused by gestation and have&#xD;
      an onset after 20 weeks of pregnancy. Although the exact etiology of PIH and preE remains&#xD;
      unknown, two interconnected mechanisms have been identified to play an important role in the&#xD;
      pathogenesis: dysfunction of the placental trophoblast and endothelial dysfunction within the&#xD;
      maternal systemic vasculature. The endothelium has been identified as the target tissue of&#xD;
      the disease. Endothelial alterations ultimately manifest as placental hypoxia and hypoplasia.&#xD;
      The neonatal thrombocytopenia and neutropenia after pregnancy-induced hypertension is a&#xD;
      result of inhibition of fetal bone marrow production of the myeloid lineage due to&#xD;
      intrauterine hypoxic environment. This study aims to investigate the hematological profile in&#xD;
      term and preterm infants born to mothers with preeclampsia. The current retrospective&#xD;
      observational study was conducted at the Clinic of Obstetrics, Gynecology and Neonatology of&#xD;
      the Emergency County Hospital, Timisoara over a period of three years, from January 2014 to&#xD;
      December 2016. All inborn patient files were analyzed as anonymised limited data sets from&#xD;
      archived records of the Neonatology Department.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 1, 2016</start_date>
  <completion_date type="Actual">August 25, 2017</completion_date>
  <primary_completion_date type="Actual">August 25, 2017</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Hematological Changes in the Newborns of Mothers with Pregnancy Induced Hypertension</measure>
    <time_frame>Blood profiles of newborns aged between 1-28 days were evaluated.</time_frame>
    <description>Evaluating the impact of Maternal Pregnancy Induced Hypertension on fetal and neonatal hematopoiesis with focus on the myeloid lineage.</description>
  </primary_outcome>
  <number_of_groups>4</number_of_groups>
  <enrollment type="Actual">6108</enrollment>
  <condition>Maternal-Fetal Exchange</condition>
  <arm_group>
    <arm_group_label>AGA Neonates</arm_group_label>
    <description>AGA Control Group Appropriate for gestational age newborns of healthy mothers</description>
  </arm_group>
  <arm_group>
    <arm_group_label>SGA Neonates</arm_group_label>
    <description>SGA - Control Group Small for gestational age newborns of healthy mothers</description>
  </arm_group>
  <arm_group>
    <arm_group_label>AGA-PIH Neonates</arm_group_label>
    <description>AGA-PIH Study Group Appropriate for gestational age newborns of mothers with pregnancy induced hypertension</description>
  </arm_group>
  <arm_group>
    <arm_group_label>SGA-PIH Neonates</arm_group_label>
    <description>SGA-PIH Study Group Small for gestational age newborns of mothers with pregnancy induced hypertension</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>AGA - Control group</intervention_name>
    <description>Data processing from Patient Medical Files</description>
    <arm_group_label>AGA Neonates</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>SGA - Control group</intervention_name>
    <description>Data processing from Patient Medical Files</description>
    <arm_group_label>SGA Neonates</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>AGA-PIH Study group</intervention_name>
    <description>Monitoring PIH-related changes in the newborn</description>
    <arm_group_label>AGA-PIH Neonates</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>SGA-PIH Study group</intervention_name>
    <description>Monitoring PIH-related changes in the newborn</description>
    <arm_group_label>SGA-PIH Neonates</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        All newborns admitted to the Neonatology Department who met the Inclusion Criteria.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age: 0-28 days&#xD;
&#xD;
          -  Newborns of healthy mothers;&#xD;
&#xD;
          -  Newborns of mothers with Pregnancy Induced Hypertension;&#xD;
&#xD;
          -  Inborn Patients;&#xD;
&#xD;
          -  Written Informed Consent signed by legal guardian.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Maternal disease other than PIH;&#xD;
&#xD;
          -  Syndromal, chromosomal or infectious diseases of the newborns;&#xD;
&#xD;
          -  Causes other then PIH for perinatal asphyxia.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>1 Day</minimum_age>
    <maximum_age>28 Days</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Alexandru Florin Rogobete, PhDs</last_name>
    <role>Principal Investigator</role>
    <affiliation>Romanian Society of Anesthesia and Intensive Care</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Dorel Sandesc, Prof</last_name>
    <role>Study Chair</role>
    <affiliation>Romanian Society of Anesthesia and Intensive Care</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Ovidiu Bedreag, Assoc Prof</last_name>
    <role>Study Director</role>
    <affiliation>Romanian Society of Anesthesia and Intensive Care</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Romanian Society of Anesthesia and Intensive Care</name>
      <address>
        <city>Timisoara</city>
        <country>Romania</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Romania</country>
  </location_countries>
  <reference>
    <citation>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.</citation>
    <PMID>18759083</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>21547086</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>9215266</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>26459642</PMID>
  </reference>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>August 26, 2017</study_first_submitted>
  <study_first_submitted_qc>August 26, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 29, 2017</study_first_posted>
  <last_update_submitted>August 26, 2017</last_update_submitted>
  <last_update_submitted_qc>August 26, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 29, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Romanian Society of Anesthesia and Intensive Care</investigator_affiliation>
    <investigator_full_name>Alexandru Florin Rogobete</investigator_full_name>
    <investigator_title>MSc, PhDs, Clinical Researcher</investigator_title>
  </responsible_party>
  <keyword>Maternal PIH</keyword>
  <keyword>Neonatal thrombocytopenia</keyword>
  <keyword>Neonatal neutropenia</keyword>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03265704
org study id: 201601MP
nct id: NCT03265704
lead sponsor: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
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.
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.
observational model: Cohort
time perspective: Retrospective
measure: Hematological Changes in the Newborns of Mothers with Pregnancy Induced Hypertension
time frame: Blood profiles of newborns aged between 1-28 days were evaluated.
description: Evaluating the impact of Maternal Pregnancy Induced Hypertension on fetal and neonatal hematopoiesis with focus on the myeloid lineage.
arm group label: AGA Neonates
description: AGA Control Group Appropriate for gestational age newborns of healthy mothers
arm group label: SGA Neonates
description: SGA - Control Group Small for gestational age newborns of healthy mothers
arm group label: AGA-PIH Neonates
description: AGA-PIH Study Group Appropriate for gestational age newborns of mothers with pregnancy induced hypertension
arm group label: SGA-PIH Neonates
description: SGA-PIH Study Group Small for gestational age newborns of mothers with pregnancy induced hypertension
intervention type: Other
intervention name: AGA - Control group
description: Data processing from Patient Medical Files
arm group label: AGA Neonates
intervention type: Other
intervention name: SGA - Control group
description: Data processing from Patient Medical Files
arm group label: SGA Neonates
intervention type: Other
intervention name: AGA-PIH Study group
description: Monitoring PIH-related changes in the newborn
arm group label: AGA-PIH Neonates
intervention type: Other
intervention name: SGA-PIH Study group
description: Monitoring PIH-related changes in the newborn
arm group label: SGA-PIH Neonates
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 1 Day
maximum age: 28 Days
healthy volunteers: No
last name: Alexandru Florin Rogobete, PhDs
role: Principal Investigator
affiliation: Romanian Society of Anesthesia and Intensive Care
last name: Dorel Sandesc, Prof
role: Study Chair
affiliation: Romanian Society of Anesthesia and Intensive Care
last name: Ovidiu Bedreag, Assoc Prof
role: Study Director
affiliation: Romanian Society of Anesthesia and Intensive Care
facility: 
country: Romania
citation: 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: 18759083
citation: 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: 21547086
citation: 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: 9215266
citation: 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: 26459642
responsible party type: Principal Investigator
investigator affiliation: Romanian Society of Anesthesia and Intensive Care
investigator full name: Alexandru Florin Rogobete
investigator title: MSc, PhDs, Clinical Researcher
sharing ipd: No