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Treatment of Scars and Dysfunctions of the Pelvic Floor in Postpartum (NoRFor)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04098965
Recruitment Status : Recruiting
First Posted : September 23, 2019
Last Update Posted : September 23, 2019
Sponsor:
Information provided by (Responsible Party):
MARÍA DEL PILAR VIDALES COLINAS, Universidad de León

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Pelvic Floor Disorders Other: Pysiotherapy techniques Other: physician treatment Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Treatment of Scarring and Dysfunction of the Pelvic Floor in Postpartum, Through Physical Therapy or by Medical Recommendations in Consultation
Actual Study Start Date : July 20, 2017
Actual Primary Completion Date : July 20, 2018
Estimated Study Completion Date : July 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Experimental
Physical Therapy Techniques
Other: Pysiotherapy techniques
manual therapy techniques, postural re-education and muscle strengthening

Control
physician treatment
Other: physician treatment
hygienic-dietary recommendations, Kegel exercises and pain relievers




Primary Outcome Measures :
  1. change in VAS from the start to the end [ Time Frame: in the begining, at thirth month, at sixth month and at the finish (one year later) ]
    Pain

  2. Change in SF36 from de start to the end [ Time Frame: in the begining, at thirth month, at sixth month and at the finish (one year later) ]
    quality of life sorth form

  3. Change in EPIQ from de start to the end [ Time Frame: in the begining, at thirth month, at sixth month and at the finish (one year later) ]
    Epidemiology of Prolapse and Incontinence Questionnaire

  4. Change in OXFORD from the start to the end [ Time Frame: in the begining, at thirth month, at sixth month and at the finish (one year later) ]
    muscle strength



Information from the National Library of Medicine

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Ages Eligible for Study:   15 Years to 49 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04098965


Contacts
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Contact: M. Pilar Master +34616965978 pilarvidacoli@hotmail.com

Locations
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Spain
Hospital Sierrallana Recruiting
Torrelavega, Cantabria, Spain, 39300
Contact: M. Pilar Vidales Colinas    +34 616965978    pilarvidacoli@hotmail.com   
Principal Investigator: María del Pilar Vidales Colinas         
Sub-Investigator: Carmen Vega Gudino         
Sub-Investigator: Jesús Mazaira Salcedo         
Sub-Investigator: María Angeles Matute         
Sub-Investigator: Gerardo Ballesteros Olmos         
Sub-Investigator: Ana Canga Villegas         
Sub-Investigator: Jesús Seco Calvo         
Sponsors and Collaborators
Universidad de León

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Responsible Party: MARÍA DEL PILAR VIDALES COLINAS, Principal Investigator, Universidad de León
ClinicalTrials.gov Identifier: NCT04098965    
Other Study ID Numbers: 321311: FISIOTERAPIA
First Posted: September 23, 2019    Key Record Dates
Last Update Posted: September 23, 2019
Last Verified: September 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Pelvic Floor Disorders
Pregnancy Complications