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Pelvic Organ Prolapse, Patient EducationPREPAREDNCT02947282

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

A study testing Educational Workshop in people with Pelvic Organ Prolapse, Patient Education, run by University of British Columbia at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 20 years and older, women only
Conditions the study is for
Pelvic Organ Prolapse, Patient Education
What is being tested?
Educational Workshop
Could I receive a placebo?
No, everyone receives an active treatment
How many people
100 participants
Where
1 siteCanada
Study dates
Jun 2013to Aug 2014
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Canada1 site
  • Nicole Koenig

    Vancouver, British Columbia, V6Z 2K5

Other trials in Canada

About this study

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.

Read the detailed description

Purpose: The purpose of this study is to determine if a single class on pelvic floor health administered during pregnancy will increase primiparous women's knowledge of pelvic floor health, decrease pelvic floor symptoms postpartum, increase the practice of pelvic floor muscle exercises, increase satisfaction with their delivery experience, and change their preferences and thoughts surrounding various modes of delivery. There are currently no such workshops being provided at St. Paul's Hospital in Vancouver BC.

Hypothesis or Aim: A single 2 hour workshop on pelvic floor health administered during pregnancy will improve primiparous women's knowledge of pelvic floor health at 6 weeks postpartum compared to a control group who do not participate in the workshop.

Justification of the Study (Background): The pelvic floor is composed of muscles and connective tissue which act to provide support for pelvic organs. Weakness or injury to the pelvic floor can result in pelvic floor dysfunction. This includes conditions such as pelvic organ prolapse, urinary incontinence, irritative bladder symptoms, fecal incontinence, pelvic pain and sexual dysfunction. Maintenance of pelvic floor health is important as diseases of the pelvic floor are bothersome, disfiguring and significantly affect quality of life of women. Though the prevalence of pelvic floor problems increases with age, it also affects women of childbearing age, especially during and after pregnancy. According to Brown et al., the prevalence of urinary incontinence 12 months before pregnancy was 10.8% and this increased to 55.9% in the third trimester. At three months postpartum, 30% of women continue to have urinary incontinence. Parity has been strongly associated with pelvic floor dysfunction later in life. According to Rortveit et al, the risk of pelvic organ prolapse was significantly increased in women with 1 (OR 2.8, 95% CI 1.1-7.2), 2 (OR 4.1, 95% CI 1.8-9.5) and 3 or more (OR 5.3, 95% CI 2.3-12.3) vaginal deliveries compared with nulliparous women. Also, forceps delivery has been associated with an increase in pelvic floor symptoms 5-10 years after delivery, especially overactive bladder (OR 2.92, 95% CI 1.44-5.93) and prolapse (OR 1.95, 95% CI 1.03-3.70).

Research on pelvic floor health education by the principal investigator showed that with improvement of pelvic floor health knowledge, there was also improvement in pelvic floor symptoms and quality of life at 3 months after a single workshop. However, introduction of pelvic floor health through a workshop would be ideal in the pregnant population, as they are a captive audience. This is the time when they employ other interventions to improve their health, such as smoking cessation, vitamin supplementation, healthy eating etc. Also, women of childbearing age are of the millennial generation. They have more interest in their own health and place greater value on quality of life compared to previous generations. Thus they are a group of motivated individuals who would implement changes to improve their future quality of life if given the appropriate information to encourage this change.

Despite current evidence demonstrating that the single most important risk factor for disruption of pelvic floor health is childbirth, pregnant women are ill-informed about pelvic floor health. A survey of health professionals in Swansea, UK, revealed that pelvic floor muscle exercises and pelvic floor health received low priority in comparison to other antenatal topics discussed by obstetric care providers with their patients. What is perhaps even more astounding was the finding that 15% of respondents, which included obstetricians, midwives and family physicians, were unable to describe pelvic floor exercises, and most health professionals surveyed felt that they had not received adequate training on pelvic floor health.

Canada does not currently have recommendations on patient education regarding pelvic floor health during pregnancy. As demonstrated by the audit performed by Ismail et al., even in a region where these guidelines exist, the education of pregnant women on this subject is poor. Our current standard of practice is to leave pelvic floor education in the hands of obstetric care providers. A survey of health professionals in the UK revealed that pelvic floor health received low priority in comparison to other topics discussed in the antenatal period. Furthermore, most obstetric care providers felt their training in pelvic floor health was inadequate. The investigators research project proposes to close the gap between patient knowledge and scientific knowledge. There is clear evidence that childbirth is the single most important risk factor in future pelvic floor conditions. There is also evidence in support of pelvic floor muscle exercises in the antepartum and postpartum period to prevent and improve pelvic floor symptoms. The investigators workshop will empower women with knowledge and allow them to make informed decisions surrounding childbirth. It will provide them with tools to improve their own pelvic floor health. A pelvic floor health workshop in the antenatal period is an innovative concept which could lead to better patient care. It may be the first step in prevention of future pelvic floor conditions.

The target population is primiparous women, 20 years or older in their first pregnancy and singleton gestation with 100 women being recruited.

Sampling method: All participants will be randomized to two groups, the random allocation lists will be generated by a statistician unassociated with the study using the SAS programming language. The allocations will be loaded onto a computer and access by a study coordinator interacting with a web-based ORACLE screen. Interactions between the coordinator and the system will be logged, including the time and date, a patient identifier (patient letter code) and the treatment allocation.

Being tested
Educational Workshop
Medical subject headings
Pelvic Organ Prolapse

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Educational WorkshopOther

    They will attend a 2 hour class on pelvic floor health

Study groups in NCT02947282
Study groupRoleWhat they receive
InterventionActive comparatorEducational Workshop
Receives: Other: Educational Workshop
ControlNo interventionThey will continue regular prenatal care as planned

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: At 6 weeks post-partum

Secondary outcomes (8)
  1. Difference in Pelvic Floor Distress Inventory questionnaire scores at 6 weeks postpartum between intervention and control groups

    Measured: At 6 weeks postpartum

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

    Measured: At 6 weeks postpartum

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

    Measured: 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

    Measured: 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

    Measured: 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.

    Measured: At Delivery

  7. Difference in actual mode of delivery between intervention and control groups based on the postpartum questionnaire

    Measured: 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

    Measured: At 6 weeks post partum

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Oct 2016 (estimated)
  2. Study startJun 2013
  3. Primary completionAug 2014
  4. Study completionAug 2014

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
100 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02947282
Sponsor's protocol ID
H12-03450
Acronym
PREPARED
Status last verified
Oct 2016
First submitted
11 Oct 2016
Last updated
2 Nov 2016
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A study testing Educational Workshop in people with Pelvic Organ Prolapse, Patient Education, run by University of British Columbia at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2016; AzTrials last refreshed its copy on 8 Nov 2026.

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