NCT02960841

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
49

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Jan 2012

Longer than P75 for phase_4

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2012

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2016

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

November 9, 2016

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 10, 2016

Completed
Last Updated

September 23, 2019

Status Verified

September 1, 2019

Enrollment Period

4 years

First QC Date

November 9, 2016

Last Update Submit

September 19, 2019

Conditions

Lymphatic Diseases

Outcome Measures

Primary Outcomes (1)

  • Pain intensity assessed by the Visual Analogue Scale

    5 weeks

Study Arms (2)

Intracavitary Manual Lymphatic Drainage

EXPERIMENTAL

Intracavitary Manual Lymphatic Drainage technique.

Other: Intracavitary Manual Lymphatic Drainage

Conventional treatment

ACTIVE COMPARATOR

Conventional treatment active comparator

Other: Conventional treatment

Interventions

Intracavitary Manual Lymphatic DrainageOTHER
Intracavitary Manual Lymphatic Drainage
Conventional treatmentOTHER
Conventional treatment

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Primiparous women

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Lymphatic Diseases

Condition Hierarchy (Ancestors)

Hemic and Lymphatic Diseases

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

November 9, 2016

First Posted

November 10, 2016

Study Start

January 1, 2012

Primary Completion

January 1, 2016

Study Completion

January 1, 2016

Last Updated

September 23, 2019

Record last verified: 2019-09