Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT02947282 |
| Other study ID # |
H12-03450 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
October 11, 2016 |
| Last updated |
October 31, 2016 |
| Start date |
June 2013 |
| Est. completion date |
August 2014 |
Study information
| Verified date |
October 2016 |
| Source |
University of British Columbia |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
Canada: Institutional Review Board |
| Study type |
Interventional
|
Clinical 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. 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.
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.
