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

NCT02947282 | Completed

• 1 other identifier: H12-03450
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Pelvic Organ Prolapse, Patient Education

Outcome Measures

Primary Outcomes (1)

• Difference in scores on a pelvic floor knowledge questionnaire at 6 weeks postpartum between intervention and control groups

  At 6 weeks post-partum

Secondary Outcomes (8)

• Difference in Pelvic Floor Distress Inventory questionnaire scores at 6 weeks postpartum between intervention and control groups

  At 6 weeks postpartum

• Difference in questionnaire scores based on Pelvic Floor Knowledge questionnaire postpartum between intervention and control groups

  At 6 weeks postpartum

• Difference in questionnaire scores on Pelvic Floor Impact Questionnaire between intervention and control groups at 6 weeks postpartum.

  At 6 weeks postpartum

• 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

  At 6 weeks postpartum

• 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

  At 6 weeks postpartum

Study Arms (2)

Intervention

ACTIVE COMPARATOR

Educational Workshop

Other: Educational Workshop

Control

NO INTERVENTION

They will continue regular prenatal care as planned

Interventions

Educational Workshop OTHER

They will attend a 2 hour class on pelvic floor health

Intervention

Eligibility Criteria

• Age: 20 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University of British Columbia: lead

Study Sites (1)

Nicole Koenig

Vancouver, British Columbia, V6Z 2K5, Canada

Location

MeSH Terms

Conditions

Pelvic Organ Prolapse

Condition Hierarchy (Ancestors)

Prolapse; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 11, 2016
• First Posted: October 27, 2016
• Study Start: June 1, 2013
• Primary Completion: August 1, 2014
• Study Completion: August 1, 2014
• Last Updated: November 2, 2016

Record last verified: 2016-10

Locations

CA (1)