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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

Tracking Information
First Submitted Date  ICMJE September 17, 2019
First Posted Date  ICMJE September 23, 2019
Last Update Posted Date September 23, 2019
Actual Study Start Date  ICMJE July 20, 2017
Actual Primary Completion Date July 20, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 19, 2019)
  • 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
  • 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
  • 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
  • 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
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Treatment of Scars and Dysfunctions of the Pelvic Floor in Postpartum
Official Title  ICMJE Treatment of Scarring and Dysfunction of the Pelvic Floor in Postpartum, Through Physical Therapy or by Medical Recommendations in Consultation
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Pelvic Floor Disorders
Intervention  ICMJE
  • Other: Pysiotherapy techniques
    manual therapy techniques, postural re-education and muscle strengthening
  • Other: physician treatment
    hygienic-dietary recommendations, Kegel exercises and pain relievers
Study Arms  ICMJE
  • Experimental: Experimental
    Physical Therapy Techniques
    Intervention: Other: Pysiotherapy techniques
  • Control
    physician treatment
    Intervention: Other: physician treatment
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: September 19, 2019)
90
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 2020
Actual Primary Completion Date July 20, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 15 Years to 49 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: M. Pilar Master +34616965978 pilarvidacoli@hotmail.com
Listed Location Countries  ICMJE Spain
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04098965
Other Study ID Numbers  ICMJE 321311: FISIOTERAPIA
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party MARÍA DEL PILAR VIDALES COLINAS, Universidad de León
Study Sponsor  ICMJE Universidad de León
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Universidad de León
Verification Date September 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP