<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/NCT03229304</url>
  </required_header>
  <id_info>
    <org_study_id>12341</org_study_id>
    <nct_id>NCT03229304</nct_id>
  </id_info>
  <brief_title>Prediction of Postpartum Hemorrhage With Uterine Artery Doppler Measurement</brief_title>
  <official_title>The Role of Uterine Artery Doppler Measurement to Predict the Amount of Postpartum Hemorrhage in Low Risk Term Pregnancy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Kanuni Sultan Suleyman Training and Research Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Kanuni Sultan Suleyman Training 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>
      The aim of the study is to evaluate the uterine artery doppler just before labour in term low&#xD;
      risk pregnancies. And to investigate with this measurement if investigators could foreseen&#xD;
      the amount of postpartum hemorrhage looking at decreased in the hematocrit values.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 1, 2016</start_date>
  <completion_date type="Actual">June 1, 2017</completion_date>
  <primary_completion_date type="Actual">May 1, 2017</primary_completion_date>
  <study_type>Observational [Patient Registry]</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>
  <target_duration>9 Months</target_duration>
  <primary_outcome>
    <measure>To measure the uterine artery Pulsatility index in term pregnant women</measure>
    <time_frame>6-8 hour before the delivery</time_frame>
    <description>With ultrasonography uterine artery doppler Pulsatility index (cm/s) will be measure</description>
  </primary_outcome>
  <primary_outcome>
    <measure>To measure the uterine artery Resistant index (cm/s) in term pregnant women</measure>
    <time_frame>6-8 hour before the delivery</time_frame>
    <description>With ultrasonography uterine artery doppler Resistant index will be measure</description>
  </primary_outcome>
  <primary_outcome>
    <measure>To measure the uterine artery mean systolic/diastolic volume (cm/s) in term pregnant women</measure>
    <time_frame>6-8 hour before the delivery</time_frame>
    <description>With ultrasonography Uterine artery doppler Mean systolic/diastolic volume (cm/s) ) will be measure</description>
  </primary_outcome>
  <enrollment type="Actual">800</enrollment>
  <condition>Postpartum Hemorrhage</condition>
  <eligibility>
    <study_pop>
      <textblock>
        The pregnant women that is term and have no risk factors for postpartum hemorrhage&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  singleton term pregnancies&#xD;
&#xD;
        Exclusion Criteria:the pregnant women who have&#xD;
&#xD;
          -  polyhydramnios&#xD;
&#xD;
          -  Large for gestational age fetuses&#xD;
&#xD;
          -  multiple pregnancies&#xD;
&#xD;
          -  preterm labour&#xD;
&#xD;
          -  chorioamnionitis&#xD;
&#xD;
          -  history of atonia or postpartum hemorrhage&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>40 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Kerem Doga Seckin</name>
      <address>
        <city>İstanbul</city>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <reference>
    <citation>Kaplanoglu M, Karateke A, Un B, Gunsoy L, Baloglu A. Evaluation of uterine artery recanalization and doppler parameters after bilateral uterine artery ligation in women with postpartum hemorrhage. Int J Clin Exp Med. 2015 May 15;8(5):7823-9. eCollection 2015.</citation>
    <PMID>26221335</PMID>
  </reference>
  <reference>
    <citation>Yildirim D, Ozyurek SE, Ekiz A, Eren EC, Hendem DU, Bafali O, Seckin KD. Comparison of active vs. expectant management of the third stage of labor in women with low risk of postpartum hemorrhage: a randomized controlled trial. Ginekol Pol. 2016;87(5):399-404. doi: 10.5603/GP.2016.0015.</citation>
    <PMID>27304659</PMID>
  </reference>
  <verification_date>April 2017</verification_date>
  <study_first_submitted>July 14, 2017</study_first_submitted>
  <study_first_submitted_qc>July 21, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">July 25, 2017</study_first_posted>
  <last_update_submitted>July 21, 2017</last_update_submitted>
  <last_update_submitted_qc>July 21, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">July 25, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Kanuni Sultan Suleyman Training and Research Hospital</investigator_affiliation>
    <investigator_full_name>Kerem Doga Seckin</investigator_full_name>
    <investigator_title>ass prof</investigator_title>
  </responsible_party>
  <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>
  </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/NCT03229304
org study id: 12341
nct id: NCT03229304
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The aim of the study is to evaluate the uterine artery doppler just before labour in term low
      risk pregnancies. And to investigate with this measurement if investigators could foreseen
      the amount of postpartum hemorrhage looking at decreased in the hematocrit values.
observational model: Cohort
time perspective: Prospective
measure: To measure the uterine artery Pulsatility index in term pregnant women
time frame: 6-8 hour before the delivery
description: With ultrasonography uterine artery doppler Pulsatility index (cm/s) will be measure
measure: To measure the uterine artery Resistant index (cm/s) in term pregnant women
time frame: 6-8 hour before the delivery
description: With ultrasonography uterine artery doppler Resistant index will be measure
measure: To measure the uterine artery mean systolic/diastolic volume (cm/s) in term pregnant women
time frame: 6-8 hour before the delivery
description: With ultrasonography Uterine artery doppler Mean systolic/diastolic volume (cm/s) ) will be measure
study pop: 
sampling method: Probability Sample
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 40 Years
healthy volunteers: No
facility: 
country: Turkey
citation: Kaplanoglu M, Karateke A, Un B, Gunsoy L, Baloglu A. Evaluation of uterine artery recanalization and doppler parameters after bilateral uterine artery ligation in women with postpartum hemorrhage. Int J Clin Exp Med. 2015 May 15;8(5):7823-9. eCollection 2015.
PMID: 26221335
citation: Yildirim D, Ozyurek SE, Ekiz A, Eren EC, Hendem DU, Bafali O, Seckin KD. Comparison of active vs. expectant management of the third stage of labor in women with low risk of postpartum hemorrhage: a randomized controlled trial. Ginekol Pol. 2016;87(5):399-404. doi: 10.5603/GP.2016.0015.
PMID: 27304659
responsible party type: Principal Investigator
investigator affiliation: Kanuni Sultan Suleyman Training and Research Hospital
investigator full name: Kerem Doga Seckin
investigator title: ass prof
mesh term: Postpartum Hemorrhage
mesh term: Hemorrhage
sharing ipd: No