<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/NCT03233607</url>
  </required_header>
  <id_info>
    <org_study_id>AAAR4466</org_study_id>
    <nct_id>NCT03233607</nct_id>
  </id_info>
  <brief_title>Time of Postpartum Hemoglobin Assessment and Blood Loss During Delivery</brief_title>
  <acronym>QUOTABL</acronym>
  <official_title>Optimal Time for Postpartum Hemoglobin Assessment and Its Correlation With Estimated Blood Loss (EBL)/Quantitative Blood Loss (QBL)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Columbia University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Columbia University</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>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a prospective cohort study of patients delivering at Columbia University Medical&#xD;
      Center/ Allen Hospital. For the primary research question, the investigators will compare the&#xD;
      change in maternal hemoglobin from postpartum day 1 to day 2 and also determine correlation&#xD;
      with estimation of blood loss (EBL) and quantitative blood loss (QBL).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Postpartum hemorrhage is a leading cause of maternal mortality and morbidity worldwide. Early&#xD;
      intervention is dependent on care providers ability to accurately estimate ongoing blood&#xD;
      loss. Studies in the past have shown that obstetricians and midwives tend to overestimate&#xD;
      blood loss when the lost volumes are small while tend to underestimate by as much as 40 to 50&#xD;
      percent when a large volume of blood is lost.&#xD;
&#xD;
      Multiple studies have shown that routine hemoglobin assessment in postpartum patients after&#xD;
      uneventful delivery either vaginal or via cesarean section, is not necessary. This leads to&#xD;
      increased cost of care without any added benefit and causes inconvenience to the patients.&#xD;
      However knowing how imprecise blood loss estimation can be it is reasonable to screen women&#xD;
      for anemia prior to discharge.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 20, 2018</start_date>
  <completion_date type="Actual">April 23, 2019</completion_date>
  <primary_completion_date type="Actual">January 4, 2019</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>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Change in maternal hemoglobin</measure>
    <time_frame>Day 1 and Day 2</time_frame>
    <description>Maternal hemoglobin will be measured on postpartum day 1 to day 2</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Correlation of maternal hemoglobin to EBL</measure>
    <time_frame>Up to 2 days after delivery</time_frame>
    <description>Maternal hemoglobin will be measured to assess correlation to visually estimated blood loss</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Correlation of maternal hemoglobin to QBL</measure>
    <time_frame>Up to 2 days after delivery</time_frame>
    <description>Maternal hemoglobin will be measured to assess correlation to quantified blood loss</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">100</enrollment>
  <condition>Hemorrhage, Postpartum</condition>
  <arm_group>
    <arm_group_label>Antepartum Patients</arm_group_label>
    <description>Includes antepartum patients receiving prenatal care at the Broadway Practice who plan to deliver at Allen Hospital in New York City (NYC). On postpartum day 1 and day 2, a sample of blood will be drawn in the morning for hemoglobin and hematocrit estimation.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Blood Draw</intervention_name>
    <description>On postpartum day 1 and day 2, a sample of blood will be drawn in the morning for hemoglobin and hematocrit estimation.</description>
    <arm_group_label>Antepartum Patients</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Pregnant women who are admitted to the Allen hospital for delivery during the recruitment&#xD;
        period.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        All antepartum patients receiving prenatal care at the Broadway Practice and plan to&#xD;
        deliver at Allen Hospital in NYC.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Patients who gave consent to participate in the study but did not deliver at Allen&#xD;
        hospital.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Rachana Gavara, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Columbia University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Columbia University Irving Medical Center</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10032</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>April 2019</verification_date>
  <study_first_submitted>July 26, 2017</study_first_submitted>
  <study_first_submitted_qc>July 26, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">July 28, 2017</study_first_posted>
  <last_update_submitted>April 23, 2019</last_update_submitted>
  <last_update_submitted_qc>April 23, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">April 24, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Columbia University</investigator_affiliation>
    <investigator_full_name>Rachana Gavara</investigator_full_name>
    <investigator_title>Assistant Professor of Obstetrics and Gynecology</investigator_title>
  </responsible_party>
  <keyword>Postpartum</keyword>
  <keyword>Hemoglobin</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Postpartum Hemorrhage</mesh_term>
    <mesh_term>Hemorrhage</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>No plans for sharing as this is a pilot study.</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/NCT03233607
org study id: AAAR4466
nct id: NCT03233607
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
is us export: No
This is a prospective cohort study of patients delivering at Columbia University Medical
      Center/ Allen Hospital. For the primary research question, the investigators will compare the
      change in maternal hemoglobin from postpartum day 1 to day 2 and also determine correlation
      with estimation of blood loss (EBL) and quantitative blood loss (QBL).
Postpartum hemorrhage is a leading cause of maternal mortality and morbidity worldwide. Early
      intervention is dependent on care providers ability to accurately estimate ongoing blood
      loss. Studies in the past have shown that obstetricians and midwives tend to overestimate
      blood loss when the lost volumes are small while tend to underestimate by as much as 40 to 50
      percent when a large volume of blood is lost.

      Multiple studies have shown that routine hemoglobin assessment in postpartum patients after
      uneventful delivery either vaginal or via cesarean section, is not necessary. This leads to
      increased cost of care without any added benefit and causes inconvenience to the patients.
      However knowing how imprecise blood loss estimation can be it is reasonable to screen women
      for anemia prior to discharge.
observational model: Cohort
time perspective: Prospective
measure: Change in maternal hemoglobin
time frame: Day 1 and Day 2
description: Maternal hemoglobin will be measured on postpartum day 1 to day 2
measure: Correlation of maternal hemoglobin to EBL
time frame: Up to 2 days after delivery
description: Maternal hemoglobin will be measured to assess correlation to visually estimated blood loss
measure: Correlation of maternal hemoglobin to QBL
time frame: Up to 2 days after delivery
description: Maternal hemoglobin will be measured to assess correlation to quantified blood loss
arm group label: Antepartum Patients
description: Includes antepartum patients receiving prenatal care at the Broadway Practice who plan to deliver at Allen Hospital in New York City (NYC). On postpartum day 1 and day 2, a sample of blood will be drawn in the morning for hemoglobin and hematocrit estimation.
intervention type: Procedure
intervention name: Blood Draw
description: On postpartum day 1 and day 2, a sample of blood will be drawn in the morning for hemoglobin and hematocrit estimation.
arm group label: Antepartum Patients
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Rachana Gavara, MD
role: Principal Investigator
affiliation: Columbia University
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Columbia University
investigator full name: Rachana Gavara
investigator title: Assistant Professor of Obstetrics and Gynecology
mesh term: Postpartum Hemorrhage
mesh term: Hemorrhage
sharing ipd: No
ipd description: No plans for sharing as this is a pilot study.