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Effect of Pelvic Floor Muscle Training Included in General Fitness Classes During Pregnacy

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ClinicalTrials.gov Identifier: NCT01578369
Recruitment Status : Completed
First Posted : April 16, 2012
Last Update Posted : April 16, 2012
Sponsor:
Information provided by (Responsible Party):
Mireia Pelaez Puente, Universidad Politecnica de Madrid

Tracking Information
First Submitted Date  ICMJE April 11, 2012
First Posted Date  ICMJE April 16, 2012
Last Update Posted Date April 16, 2012
Study Start Date  ICMJE September 2009
Actual Primary Completion Date June 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 13, 2012)
Change from baseline in ICIQ-Urinary Incontinence Short Form Questionnaire [ Time Frame: Week 10-14 gestation (baseline), week 36-39 (after intervention) ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: April 13, 2012)
Change from baseline in King's Health Questionnaire [ Time Frame: week 10-14 of gestation (baseline), week 36-39 (after intervention) ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effect of Pelvic Floor Muscle Training Included in General Fitness Classes During Pregnacy
Official Title  ICMJE Pelvic Floor Muscle Training Included in General Fitness Classes is Effective in Primary Prevention of Urinary Incontince in Pregnancy. A Randomized Controlled Trial
Brief Summary To investigate the effect of pelvic floor muscle training taught in a general exercise class during pregnancy to prevent urinary incontinence in nulliparous continent pregnant women.
Detailed Description Pregnancy and childbirth are known risk factors for development of female urinary incontinence (UI). Studies have found that Pelvic Floor Mucle Trainig (PFMT) is effective in preventing and reducing UI during pregnancy and after childbirth. However, in a recent study, no effect was found when PFMT were taught in a general fitness class without former palpation of the pelvic floor muscles (Bo y Haakstad, 2011).
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE
  • Pregnancy
  • Urinary Incontinence
Intervention  ICMJE Other: Exercise classes with pelvic floor muscle training
Supervised exercise classes which included pelvic floor muscle training. 3 sessions per week. 55-60 min per session, with 10 minutes of pelvic floor muscle training. At least during 22 weeks.
Study Arms  ICMJE
  • Experimental: Exercise group
    Supervised exercise classes which included pelvic floor muscle training. 3 sessions per week. 55-60 min per session, with 10 minutes of pelvic floor muscle training. At least during 22 weeks.
    Intervention: Other: Exercise classes with pelvic floor muscle training
  • No Intervention: Control
    Usual care
Publications *

*   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 Completed
Actual Enrollment  ICMJE
 (submitted: April 13, 2012)
169
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE June 2011
Actual Primary Completion Date June 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Nulliparous with singleton baby
  • Not suffering from urinary incontinence
  • Giving birth at Hospital Universitario de Fuenlabrada
  • Able to comunicate in Spanish
  • Being healthy and able to exercise following American College of Obstetricians and Gynecologists (ACOG) guidelines

Exclusion Criteria:

  • Multiparity
  • At risk of Premature birth
  • Following another exercise program
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 50 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Spain
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01578369
Other Study ID Numbers  ICMJE 240/09B
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Mireia Pelaez Puente, Universidad Politecnica de Madrid
Study Sponsor  ICMJE Universidad Politecnica de Madrid
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Rubén Barakat, PhD Universidad Politécnica de Madrid
Principal Investigator: Mireia Peláez, PhD Universidad Politécnica de Madrid
PRS Account Universidad Politecnica de Madrid
Verification Date April 2012

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