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Effectiveness of Intracavitary Manual Lymphatic Drainage (IMLD)

Primary Purpose

Lymphatic Diseases

Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Intracavitary Manual Lymphatic Drainage
Conventional treatment
Sponsored by
Universidad Europea de Madrid
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lymphatic Diseases

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • A sample of 49 second-trimester pregnant women with gestational edema with more than 18 years of age

Exclusion Criteria:

  • Primiparous women

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Intracavitary Manual Lymphatic Drainage

    Conventional treatment

    Arm Description

    Intracavitary Manual Lymphatic Drainage technique.

    Conventional treatment active comparator

    Outcomes

    Primary Outcome Measures

    Pain intensity assessed by the Visual Analogue Scale

    Secondary Outcome Measures

    Full Information

    First Posted
    November 9, 2016
    Last Updated
    September 19, 2019
    Sponsor
    Universidad Europea de Madrid
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02960841
    Brief Title
    Effectiveness of Intracavitary Manual Lymphatic Drainage
    Acronym
    IMLD
    Official Title
    Effectiveness of Intracavitary Manual Lymphatic Drainage Versus Conventional Treatment in the Prevention of Perineal Trauma During Labor.
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2019
    Overall Recruitment Status
    Completed
    Study Start Date
    January 2012 (undefined)
    Primary Completion Date
    January 2016 (Actual)
    Study Completion Date
    January 2016 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Universidad Europea de Madrid

    4. Oversight

    5. Study Description

    Brief Summary
    The aim of this study was to determine the effectiveness of Intracavitary Manual Lymphatic Drainage (IMLD) in the reduction of the perineal trauma and the symptoms of vaginal edema, the prevention of complications during the expulsive and the improvement in the postpartum recovery, compared to conventional treatment during the gestation, in women with the second partum. The weekly treatment is performed from the 25th gestational week in women with vulvar edema.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Lymphatic Diseases

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Masking
    Outcomes Assessor
    Allocation
    Randomized
    Enrollment
    49 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Intracavitary Manual Lymphatic Drainage
    Arm Type
    Experimental
    Arm Description
    Intracavitary Manual Lymphatic Drainage technique.
    Arm Title
    Conventional treatment
    Arm Type
    Active Comparator
    Arm Description
    Conventional treatment active comparator
    Intervention Type
    Other
    Intervention Name(s)
    Intracavitary Manual Lymphatic Drainage
    Intervention Type
    Other
    Intervention Name(s)
    Conventional treatment
    Primary Outcome Measure Information:
    Title
    Pain intensity assessed by the Visual Analogue Scale
    Time Frame
    5 weeks

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: A sample of 49 second-trimester pregnant women with gestational edema with more than 18 years of age Exclusion Criteria: Primiparous women

    12. IPD Sharing Statement

    Learn more about this trial

    Effectiveness of Intracavitary Manual Lymphatic Drainage

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