<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/NCT03020355</url>
  </required_header>
  <id_info>
    <org_study_id>167</org_study_id>
    <nct_id>NCT03020355</nct_id>
  </id_info>
  <brief_title>Comparison of Blood Loss in Using vs Not Using Placental Cord Drainage After Spontaneous Vaginal Delivery</brief_title>
  <official_title>Comparison of Blood Loss in Using vs Not Using Placental Cord Drainage After Spontaneous Vaginal Delivery</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Zeynep Kamil Maternity and Pediatric Research and Training Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Zeynep Kamil Maternity and Pediatric Research and Training Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Comparison of effectiveness of placental blood drainage after spontaneous vaginal delivery in&#xD;
      decreasing the duration, blood loss,and complications of the third stage, against no drainage&#xD;
      of placental blood.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The patients will prospectively randomized equally into two groups (100 each in the study and&#xD;
      control groups).&#xD;
&#xD;
      Group-A (Study group)-Placental blood was drained.&#xD;
&#xD;
      Group-B (Control group)-Placental blood was not drained.&#xD;
&#xD;
      In all the patients detailed medical and obstetric history will taken. In each patient, the&#xD;
      pre-delivery pulse rate, blood pressure, and Hb gm% will noted. Immediately after vaginal&#xD;
      delivery, after clamping and cutting the cord-the cord will unclamped and the blood will&#xD;
      drained until the flow ceased. In the control group, the clamped cord will not released.&#xD;
      Blood lost in the third stage of labour will measured by collecting the blood measuring bag.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date>February 2017</start_date>
  <completion_date type="Anticipated">June 2017</completion_date>
  <primary_completion_date type="Anticipated">May 2017</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Blood lost</measure>
    <time_frame>through delivery completion, an average of 30 minutes</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>The duration of the third stage</measure>
    <time_frame>through the duration of the third stage, an average 45 minutes</time_frame>
    <description>The duration of the third stage will calculated using a stop watch.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">200</enrollment>
  <condition>Placental Blood Drainage</condition>
  <arm_group>
    <arm_group_label>Placental Blood Drainage</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Immediately after vaginal delivery, after clamping and cutting the cord-the cord will unclamped and the blood will drained until the flow ceased.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>not Placental Blood Drainage</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>In the control group, the clamped cord will not released.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Placental Blood Drainage</intervention_name>
    <description>Immediately after vaginal delivery, after clamping and cutting the cord-the cord will unclamped and the blood will drained until the flow ceased.</description>
    <arm_group_label>Placental Blood Drainage</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>not Placental Blood Drainage</intervention_name>
    <description>In the control group, the clamped cord will not released.</description>
    <arm_group_label>not Placental Blood Drainage</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Singleton pregnancy&#xD;
&#xD;
          -  Vertex presentation&#xD;
&#xD;
          -  Gestational age of 37 weeks (or) more&#xD;
&#xD;
          -  No major medical (or) obstetric complications&#xD;
&#xD;
          -  Spontaneous vaginal delivery&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Hb\7 gm/dl&#xD;
&#xD;
          -  History of APH&#xD;
&#xD;
          -  Instrumental delivery&#xD;
&#xD;
          -  Multiple pregnancy&#xD;
&#xD;
          -  Malpresentations&#xD;
&#xD;
          -  Large baby (more than 3.5 kg)&#xD;
&#xD;
          -  Polyhydramnios&#xD;
&#xD;
          -  Known coagulations disorders&#xD;
&#xD;
          -  Previous surgeries on the uterus&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>15 Years</minimum_age>
    <maximum_age>50 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <results_reference>
    <citation>Roy P, Sujatha MS, Bhandiwad A, Biswas B, Chatterjee A. Placental Blood Drainage as a Part of Active Management of Third Stage of Labour After Spontaneous Vaginal Delivery. J Obstet Gynaecol India. 2016 Oct;66(Suppl 1):242-5. doi: 10.1007/s13224-016-0857-3. Epub 2016 Mar 12.</citation>
    <PMID>27651611</PMID>
  </results_reference>
  <results_reference>
    <citation>Soltani H, Poulose TA, Hutchon DR. Placental cord drainage after vaginal delivery as part of the management of the third stage of labour. Cochrane Database Syst Rev. 2011 Sep 7;2011(9):CD004665. doi: 10.1002/14651858.CD004665.pub3.</citation>
    <PMID>21901693</PMID>
  </results_reference>
  <verification_date>January 2017</verification_date>
  <study_first_submitted>December 22, 2016</study_first_submitted>
  <study_first_submitted_qc>January 11, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 13, 2017</study_first_posted>
  <last_update_submitted>January 11, 2017</last_update_submitted>
  <last_update_submitted_qc>January 11, 2017</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 13, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Zeynep Kamil Maternity and Pediatric Research and Training Hospital</investigator_affiliation>
    <investigator_full_name>Ahmet Eser</investigator_full_name>
    <investigator_title>Medical Doctor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hemorrhage</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</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/NCT03020355
org study id: 167
nct id: NCT03020355
lead sponsor: 
has dmc: No
Comparison of effectiveness of placental blood drainage after spontaneous vaginal delivery in
      decreasing the duration, blood loss,and complications of the third stage, against no drainage
      of placental blood.
The patients will prospectively randomized equally into two groups (100 each in the study and
      control groups).

      Group-A (Study group)-Placental blood was drained.

      Group-B (Control group)-Placental blood was not drained.

      In all the patients detailed medical and obstetric history will taken. In each patient, the
      pre-delivery pulse rate, blood pressure, and Hb gm% will noted. Immediately after vaginal
      delivery, after clamping and cutting the cord-the cord will unclamped and the blood will
      drained until the flow ceased. In the control group, the clamped cord will not released.
      Blood lost in the third stage of labour will measured by collecting the blood measuring bag.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Blood lost
time frame: through delivery completion, an average of 30 minutes
measure: The duration of the third stage
time frame: through the duration of the third stage, an average 45 minutes
description: The duration of the third stage will calculated using a stop watch.
arm group label: Placental Blood Drainage
arm group type: Experimental
description: Immediately after vaginal delivery, after clamping and cutting the cord-the cord will unclamped and the blood will drained until the flow ceased.
arm group label: not Placental Blood Drainage
arm group type: Active Comparator
description: In the control group, the clamped cord will not released.
intervention type: Procedure
intervention name: Placental Blood Drainage
description: Immediately after vaginal delivery, after clamping and cutting the cord-the cord will unclamped and the blood will drained until the flow ceased.
arm group label: Placental Blood Drainage
intervention type: Procedure
intervention name: not Placental Blood Drainage
description: In the control group, the clamped cord will not released.
arm group label: not Placental Blood Drainage
criteria: 
gender: Female
minimum age: 15 Years
maximum age: 50 Years
healthy volunteers: Accepts Healthy Volunteers
citation: Roy P, Sujatha MS, Bhandiwad A, Biswas B, Chatterjee A. Placental Blood Drainage as a Part of Active Management of Third Stage of Labour After Spontaneous Vaginal Delivery. J Obstet Gynaecol India. 2016 Oct;66(Suppl 1):242-5. doi: 10.1007/s13224-016-0857-3. Epub 2016 Mar 12.
PMID: 27651611
citation: Soltani H, Poulose TA, Hutchon DR. Placental cord drainage after vaginal delivery as part of the management of the third stage of labour. Cochrane Database Syst Rev. 2011 Sep 7;2011(9):CD004665. doi: 10.1002/14651858.CD004665.pub3.
PMID: 21901693
responsible party type: Principal Investigator
investigator affiliation: Zeynep Kamil Maternity and Pediatric Research and Training Hospital
investigator full name: Ahmet Eser
investigator title: Medical Doctor
mesh term: Hemorrhage
sharing ipd: Yes