Lymphatic DiseasesPhase 4IMLDNCT02960841
Effectiveness of Intracavitary Manual Lymphatic Drainage
A Phase 4 study testing Intracavitary Manual Lymphatic Drainage and Conventional treatment in people with Lymphatic Diseases, run by Universidad Europea de Madrid.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Lymphatic Diseases
- What is being tested?
- Intracavitary Manual Lymphatic Drainage and Conventional treatment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 49 participants
- Where
- No sites listed yet
- Study dates
- Jan 2012to Jan 2016
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- A sample of 49 second-trimester pregnant women with gestational edema with more than 18 years of age
Who cannot join
- Primiparous women
About this study
Official title: 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.
- Conditions
- Lymphatic Diseases
- Being tested
- Intracavitary Manual Lymphatic Drainage, Conventional treatment
- Medical subject headings
- Lymphatic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intracavitary Manual Lymphatic DrainageOther
Conventional treatmentOther
| Study group | Role | What they receive |
|---|---|---|
| Intracavitary Manual Lymphatic Drainage | Experimental | Intracavitary Manual Lymphatic Drainage technique. Receives: Other: Intracavitary Manual Lymphatic Drainage |
| Conventional treatment | Active comparator | Conventional treatment active comparator Receives: Other: Conventional treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain intensity assessed by the Visual Analogue Scale
Measured: 5 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2016 (estimated)
- Study startJan 2012
- Primary completionJan 2016
- Study completionJan 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lymphatic DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad Europea de Madrid
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Monica de La cueva, Universidad Europea de Madrid
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02960841
- Sponsor's protocol ID
- UEM_TRA_2011_01
- Acronym
- IMLD
- Status last verified
- Sep 2019
- First submitted
- 9 Nov 2016
- Last updated
- 23 Sep 2019
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Intracavitary Manual Lymphatic Drainage Versus Conventional Treatment in the Prevention of Perineal Trauma During Labor.
- ClinicalTrials.gov ID
- NCT02960841
- Acronym / sponsor ID
- IMLD / UEM_TRA_2011_01
- Conditions
- Lymphatic Diseases
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- Universidad Europea de MadridUniversity, hospital or other
- Study start
- Jan 2012
- Primary completion
- Jan 2016 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 10 Nov 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intracavitary Manual Lymphatic Drainage | Experimental | Other: Intracavitary Manual Lymphatic DrainageIntracavitary Manual Lymphatic Drainage technique. |
| Conventional treatment | Active comparator | Other: Conventional treatmentConventional treatment active comparator |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- A sample of 49 second-trimester pregnant women with gestational edema with more than 18 years of age
Key exclusion criteria (1 listed)
- Primiparous women
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intracavitary Manual Lymphatic Drainage | Other | Intracavitary Manual Lymphatic Drainage |
| Conventional treatment | Other | Conventional treatment |
Primary outcome
Pain intensity assessed by the Visual Analogue Scale
Time frame: 5 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Intracavitary Manual Lymphatic Drainage and Conventional treatment in people with Lymphatic Diseases, run by Universidad Europea de Madrid.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain intensity assessed by the Visual Analogue Scale (time frame: 5 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2019.