<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/NCT04449601</url>
  </required_header>
  <id_info>
    <org_study_id>E52332816/49</org_study_id>
    <nct_id>NCT04449601</nct_id>
  </id_info>
  <brief_title>Normotensive and Hypertensive Placental Abruptions</brief_title>
  <official_title>Comparison of Maternal Neonatal Outcomes of Normotensive and Hypertensive Placental Abruptions: A Novel Approach</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hatice Akkaya</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Kayseri Education and Research Hospital</source>
  <oversight_info>
    <has_dmc>No</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>
      Placental abruption is a significant cause of both maternal morbidity and neonatal morbidity&#xD;
      and mortality. Most abruptions accept to be related to a chronic placental disease process.&#xD;
      Therefore, it is very important to understand these processes. To analyze maternal and&#xD;
      neonatal effects of placental abruption(PA) through a novel classification in the presence of&#xD;
      hypertension. Initial hemoglobin parameters were also compared to predict pregnancy outcomes&#xD;
      in addition to hypertension.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Objective: We aimed to classify placental abruption according to hypertension status.&#xD;
&#xD;
      Methods: This retrospective cohort designed study was conducted on 115 pregnant women with&#xD;
      placental abruption. The main parameters scanned and recorded from the hospital database and&#xD;
      patient medical files. Two groups were classified regarding of presence or absence of&#xD;
      hypertension (53 hypertensive, 62 normotensive). Maternal demographical and clinical&#xD;
      characteristics (abdominal pain, vaginal bleeding) were recorded. APGAR scores below 5 at 1&#xD;
      and 5 min., fetal or neonatal death, admission and length of stay in Neonatal Intensive Care&#xD;
      Unit(NICU) were also investigated and compared between the groups.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 1, 2016</start_date>
  <completion_date type="Actual">November 30, 2017</completion_date>
  <primary_completion_date type="Actual">April 30, 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>blood pressure measurement</measure>
    <time_frame>2 minute</time_frame>
    <description>mm Hg</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>hemogram parameters WBC(white blood cell) ,PLT(Platelet), MPV(mean platelet volume), HGB(hemoglobin), Neutrophil lymphocyte ratio..)</measure>
    <time_frame>first 1 hour</time_frame>
    <description>complete blood test retrospective complete blood count analysis</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>maternal and newborn length, weight</measure>
    <time_frame>5 minute</time_frame>
    <description>centimeters,kilogram</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>APGAR score</measure>
    <time_frame>5 minute</time_frame>
    <description>1st and 5th minute newborn assesment</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">115</enrollment>
  <condition>Abruptio Placentae; Affecting Fetus or Newborn</condition>
  <arm_group>
    <arm_group_label>Group 1 (with hypertension )</arm_group_label>
    <description>Two groups were classified regarding of presence or absence of hypertension (53 hypertensive, 62 normotensive).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group 2( without hypertension)</arm_group_label>
    <description>Two groups were classified regarding of presence or absence of hypertension (53 hypertensive, 62 normotensive).</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>clinical assesment</intervention_name>
    <description>Comparison of Hypertensive group and normotensive group</description>
    <arm_group_label>Group 1 (with hypertension )</arm_group_label>
    <arm_group_label>Group 2( without hypertension)</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Two groups were formed according to presence or absence of hypertension (53 hypertensive,&#xD;
        62 normotensive) who has placental abruption.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  spontaneous,&#xD;
&#xD;
          -  singleton pregnancies&#xD;
&#xD;
          -  above 25 weeks of gestations with positive fetal cardiac activity&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  multiple gestations,&#xD;
&#xD;
          -  presence of fetal or maternal infection,&#xD;
&#xD;
          -  chronic inflammatory diseases or connective tissue disorders&#xD;
&#xD;
          -  history of myocardial infarction,&#xD;
&#xD;
          -  thrombosis&#xD;
&#xD;
          -  history of steroid drug usage.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>45 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Hatice Akkaya, Ass Prof</last_name>
    <role>Principal Investigator</role>
    <affiliation>Kayseri Education and Research Hospital</affiliation>
  </overall_official>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 20, 2020</study_first_submitted>
  <study_first_submitted_qc>June 23, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 29, 2020</study_first_posted>
  <last_update_submitted>June 23, 2020</last_update_submitted>
  <last_update_submitted_qc>June 23, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 29, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Kayseri Education and Research Hospital</investigator_affiliation>
    <investigator_full_name>Hatice Akkaya</investigator_full_name>
    <investigator_title>Associate Professor</investigator_title>
  </responsible_party>
  <keyword>Abruptio placenta</keyword>
  <keyword>complete blood count</keyword>
  <keyword>hypertension</keyword>
  <keyword>perinatal outcome.</keyword>
  <keyword>mean platelet volume</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Abruptio Placentae</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>The data belonging to participant only will be available to any researcher or editorial review board if needed.</ipd_description>
  </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/NCT04449601
org study id: E52332816/49
nct id: NCT04449601
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Placental abruption is a significant cause of both maternal morbidity and neonatal morbidity
      and mortality. Most abruptions accept to be related to a chronic placental disease process.
      Therefore, it is very important to understand these processes. To analyze maternal and
      neonatal effects of placental abruption(PA) through a novel classification in the presence of
      hypertension. Initial hemoglobin parameters were also compared to predict pregnancy outcomes
      in addition to hypertension.
Objective: We aimed to classify placental abruption according to hypertension status.

      Methods: This retrospective cohort designed study was conducted on 115 pregnant women with
      placental abruption. The main parameters scanned and recorded from the hospital database and
      patient medical files. Two groups were classified regarding of presence or absence of
      hypertension (53 hypertensive, 62 normotensive). Maternal demographical and clinical
      characteristics (abdominal pain, vaginal bleeding) were recorded. APGAR scores below 5 at 1
      and 5 min., fetal or neonatal death, admission and length of stay in Neonatal Intensive Care
      Unit(NICU) were also investigated and compared between the groups.
observational model: Cohort
time perspective: Retrospective
measure: blood pressure measurement
time frame: 2 minute
description: mm Hg
measure: hemogram parameters WBC(white blood cell) ,PLT(Platelet), MPV(mean platelet volume), HGB(hemoglobin), Neutrophil lymphocyte ratio..)
time frame: first 1 hour
description: complete blood test retrospective complete blood count analysis
measure: maternal and newborn length, weight
time frame: 5 minute
description: centimeters,kilogram
measure: APGAR score
time frame: 5 minute
description: 1st and 5th minute newborn assesment
arm group label: Group 1 (with hypertension )
description: Two groups were classified regarding of presence or absence of hypertension (53 hypertensive, 62 normotensive).
arm group label: Group 2( without hypertension)
description: Two groups were classified regarding of presence or absence of hypertension (53 hypertensive, 62 normotensive).
intervention type: Other
intervention name: clinical assesment
description: Comparison of Hypertensive group and normotensive group
arm group label: Group 1 (with hypertension )
arm group label: Group 2( without hypertension)
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 45 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Hatice Akkaya, Ass Prof
role: Principal Investigator
affiliation: Kayseri Education and Research Hospital
responsible party type: Sponsor-Investigator
investigator affiliation: Kayseri Education and Research Hospital
investigator full name: Hatice Akkaya
investigator title: Associate Professor
mesh term: Abruptio Placentae
sharing ipd: No
ipd description: The data belonging to participant only will be available to any researcher or editorial review board if needed.