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PREgnancy-associated Pelvic Floor Health Knowledge And REDuction of Symptoms: The PREPARED Trial (PREPARED)

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ClinicalTrials.gov Identifier: NCT02947282
Recruitment Status : Completed
First Posted : October 27, 2016
Last Update Posted : November 2, 2016
Sponsor:
Information provided by (Responsible Party):
University of British Columbia

Brief Summary:
The pelvic floor is composed of muscles and connective tissue which acts to provide support for pelvic organs, and weakness or injury to the pelvic floor can result in pelvic floor dysfunction. Respect for patient autonomy is a guiding principle in medicine and is of increasing importance for patients. The PREPARED Trial hopes to demonstrate whether a single workshop on pelvic floor health during pregnancy will lead to improved knowledge of pelvic floor symptoms postpartum, increase the practice of pelvic floor muscle exercises, increase satisfaction with their delivery experience, and change participants preferences and thoughts surrounding various modes of delivery.

Condition or disease Intervention/treatment Phase
Pelvic Organ Prolapse, Patient Education Other: Educational Workshop Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: PREgnancy-associated Pelvic Floor Health Knowledge And REDuction of Symptoms: The PREPARED Trial
Study Start Date : June 2013
Actual Primary Completion Date : August 2014
Actual Study Completion Date : August 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pregnancy

Arm Intervention/treatment
Active Comparator: Intervention
Educational Workshop
Other: Educational Workshop
They will attend a 2 hour class on pelvic floor health

No Intervention: Control
They will continue regular prenatal care as planned



Primary Outcome Measures :
  1. Difference in scores on a pelvic floor knowledge questionnaire at 6 weeks postpartum between intervention and control groups [ Time Frame: At 6 weeks post-partum ]

Secondary Outcome Measures :
  1. Difference in Pelvic Floor Distress Inventory questionnaire scores at 6 weeks postpartum between intervention and control groups [ Time Frame: At 6 weeks postpartum ]
  2. Difference in questionnaire scores based on Pelvic Floor Knowledge questionnaire postpartum between intervention and control groups [ Time Frame: At 6 weeks postpartum ]
  3. Difference in questionnaire scores on Pelvic Floor Impact Questionnaire between intervention and control groups at 6 weeks postpartum. [ Time Frame: At 6 weeks postpartum ]
  4. Difference in knowledge of practice of pelvic floor muscle exercises based on postpartum questionnaire scores at 6 weeks postpartum between intervention and control groups based on postpartum questionnaire [ Time Frame: At 6 weeks postpartum ]
  5. Difference in frequency of practice of pelvic floor muscle exercises based on postpartum questionnaire scores at 6 weeks postpartum between intervention and control groups based on postpartum questionnaire [ Time Frame: At 6 weeks postpartum ]
  6. Change in mode of delivery preferences before and after the class in the intervention group based on the postpartum questionnaire. [ Time Frame: At Delivery ]
  7. Difference in actual mode of delivery between intervention and control groups based on the postpartum questionnaire [ Time Frame: At Delivery ]
  8. Difference in global satisfaction rating with pelvic floor health and mode of delivery at 6 weeks postpartum between intervention and control groups based on postpartum questionnaire [ Time Frame: At 6 weeks post partum ]


Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Women 20 years or older, in their first pregnancy, singleton gestation, from various obstetrical care providers (general practitioner, midwife, obstetrician), planning to deliver at St. Paul's hospital in Vancouver

Exclusion Criteria:

  • Women under 20 years of age, multiple gestation, unable to understand English

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): NCT02947282


Locations
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Canada, British Columbia
Nicole Koenig
Vancouver, British Columbia, Canada, V6Z 2K5
Sponsors and Collaborators
University of British Columbia
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Responsible Party: University of British Columbia
ClinicalTrials.gov Identifier: NCT02947282    
Other Study ID Numbers: H12-03450
First Posted: October 27, 2016    Key Record Dates
Last Update Posted: November 2, 2016
Last Verified: October 2016
Additional relevant MeSH terms:
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Prolapse
Pelvic Organ Prolapse
Pathological Conditions, Anatomical