Treatment of Scars and Dysfunctions of the Pelvic Floor in Postpartum

NCT ID: NCT04098965

Last Updated: 2019-09-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-07-20

Study Completion Date

2020-07-31

Brief Summary

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Recruitment of patients who have suffered third- and fourth-degree perineal tear during childbirth, and who have given birth at the Hospital Universitario Marqués de Valdecilla (Santander, Spain). They are distributed randomly in two groups an experimental group who apply techniques of physiotherapy and a control group, receiving medical treatment.

At the same time is recruited the same number of patients who have not suffered tear and whose birth has been instrumental, dividing into two groups, control and experimental. And the same number of patients who have given birth but have not suffered tear or instrumental delivery, divided also into control group and experimental.

Detailed Description

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Conditions

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Pelvic Floor Disorders

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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Experimental

Physical Therapy Techniques

Group Type EXPERIMENTAL

Pysiotherapy techniques

Intervention Type OTHER

manual therapy techniques, postural re-education and muscle strengthening

Control

physician treatment

Group Type OTHER

physician treatment

Intervention Type OTHER

hygienic-dietary recommendations, Kegel exercises and pain relievers

Interventions

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Pysiotherapy techniques

manual therapy techniques, postural re-education and muscle strengthening

Intervention Type OTHER

physician treatment

hygienic-dietary recommendations, Kegel exercises and pain relievers

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Patients who have dysfunctions in the pelvic floor after childbirth
* Patients who have given birth at the Hospital Universitario Marqués de Valdecilla
* Patients who do not have any medical alteration that does not indicate the treatment

Exclusion Criteria

* Patients who do not have pelvic floor dysfunctions after childbirth
* Patients who have not given birth at the Hospital Universitario Marqués de Valdecilla
* Patients who have any medical changes that counter the treatment
Minimum Eligible Age

15 Years

Maximum Eligible Age

49 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Universidad de León

OTHER

Sponsor Role lead

Responsible Party

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MARÍA DEL PILAR VIDALES COLINAS

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Hospital Sierrallana

Torrelavega, Cantabria, Spain

Site Status RECRUITING

Countries

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Spain

Central Contacts

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M. Pilar Master

Role: CONTACT

+34616965978

Facility Contacts

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M. Pilar Vidales Colinas

Role: primary

+34 616965978

Other Identifiers

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321311: FISIOTERAPIA

Identifier Type: -

Identifier Source: org_study_id

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