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Comparison of Blood Loss in Using vs Not Using Placental Cord Drainage After Spontaneous Vaginal Delivery

Primary Purpose

Placental Blood Drainage

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Placental Blood Drainage
not Placental Blood Drainage
Sponsored by
Zeynep Kamil Maternity and Pediatric Research and Training Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Placental Blood Drainage

Eligibility Criteria

15 Years - 50 Years (Child, Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • Singleton pregnancy
  • Vertex presentation
  • Gestational age of 37 weeks (or) more
  • No major medical (or) obstetric complications
  • Spontaneous vaginal delivery

Exclusion Criteria:

  • Hb\7 gm/dl
  • History of APH
  • Instrumental delivery
  • Multiple pregnancy
  • Malpresentations
  • Large baby (more than 3.5 kg)
  • Polyhydramnios
  • Known coagulations disorders
  • Previous surgeries on the uterus

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Placental Blood Drainage

    not Placental Blood Drainage

    Arm Description

    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.

    Outcomes

    Primary Outcome Measures

    Blood lost

    Secondary Outcome Measures

    The duration of the third stage
    The duration of the third stage will calculated using a stop watch.

    Full Information

    First Posted
    December 22, 2016
    Last Updated
    January 11, 2017
    Sponsor
    Zeynep Kamil Maternity and Pediatric Research and Training Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03020355
    Brief Title
    Comparison of Blood Loss in Using vs Not Using Placental Cord Drainage After Spontaneous Vaginal Delivery
    Official Title
    Comparison of Blood Loss in Using vs Not Using Placental Cord Drainage After Spontaneous Vaginal Delivery
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2017
    Overall Recruitment Status
    Unknown status
    Study Start Date
    February 2017 (undefined)
    Primary Completion Date
    May 2017 (Anticipated)
    Study Completion Date
    June 2017 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Zeynep Kamil Maternity and Pediatric Research and Training Hospital

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    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.
    Detailed Description
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Placental Blood Drainage

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    200 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Placental Blood Drainage
    Arm Type
    Experimental
    Arm 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 Title
    not Placental Blood Drainage
    Arm Type
    Active Comparator
    Arm Description
    In the control group, the clamped cord will not released.
    Intervention Type
    Procedure
    Intervention Name(s)
    Placental Blood Drainage
    Intervention Description
    Immediately after vaginal delivery, after clamping and cutting the cord-the cord will unclamped and the blood will drained until the flow ceased.
    Intervention Type
    Procedure
    Intervention Name(s)
    not Placental Blood Drainage
    Intervention Description
    In the control group, the clamped cord will not released.
    Primary Outcome Measure Information:
    Title
    Blood lost
    Time Frame
    through delivery completion, an average of 30 minutes
    Secondary Outcome Measure Information:
    Title
    The duration of the third stage
    Description
    The duration of the third stage will calculated using a stop watch.
    Time Frame
    through the duration of the third stage, an average 45 minutes

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    15 Years
    Maximum Age & Unit of Time
    50 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Singleton pregnancy Vertex presentation Gestational age of 37 weeks (or) more No major medical (or) obstetric complications Spontaneous vaginal delivery Exclusion Criteria: Hb\7 gm/dl History of APH Instrumental delivery Multiple pregnancy Malpresentations Large baby (more than 3.5 kg) Polyhydramnios Known coagulations disorders Previous surgeries on the uterus

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes
    Citations:
    PubMed Identifier
    27651611
    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.
    Results Reference
    result
    PubMed Identifier
    21901693
    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.
    Results Reference
    result

    Learn more about this trial

    Comparison of Blood Loss in Using vs Not Using Placental Cord Drainage After Spontaneous Vaginal Delivery

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