Effectiveness of Intracavitary Manual Lymphatic Drainage (IMLD)

September 19, 2019 updated by: Monica de La cueva, Universidad Europea de Madrid

Effectiveness of Intracavitary Manual Lymphatic Drainage Versus Conventional Treatment in the Prevention of Perineal Trauma During Labor.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

49

Phase

  • Phase 4

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • Primiparous women

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Intracavitary Manual Lymphatic Drainage
Intracavitary Manual Lymphatic Drainage technique.
Other: Intracavitary Manual Lymphatic Drainage
ACTIVE_COMPARATOR: Conventional treatment
Conventional treatment active comparator
Other: Conventional treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Pain intensity assessed by the Visual Analogue Scale
Time Frame: 5 weeks
5 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universidad Europea de Madrid

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2012

Primary Completion (ACTUAL)

January 1, 2016

Study Completion (ACTUAL)

January 1, 2016

Study Registration Dates

First Submitted

November 9, 2016

First Submitted That Met QC Criteria

November 9, 2016

First Posted (ESTIMATE)

November 10, 2016

Study Record Updates

Last Update Posted (ACTUAL)

September 23, 2019

Last Update Submitted That Met QC Criteria

September 19, 2019

Last Verified

September 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UEM_TRA_2011_01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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