PREgnancy-associated Pelvic Floor Health Knowledge And REDuction of Symptoms: The PREPARED Trial
NCT ID: NCT02947282
Last Updated: 2016-11-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
100 participants
INTERVENTIONAL
2013-06-30
2014-08-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Intervention
Educational Workshop
Educational Workshop
They will attend a 2 hour class on pelvic floor health
Control
They will continue regular prenatal care as planned
No interventions assigned to this group
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Educational Workshop
They will attend a 2 hour class on pelvic floor health
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
Exclusion Criteria
20 Years
FEMALE
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
University of British Columbia
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Nicole Koenig
Vancouver, British Columbia, Canada
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
H12-03450
Identifier Type: -
Identifier Source: org_study_id