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OpenTrials
Completed

NCT Number: NCT04754984

Postpartum Pelvic Floor Workshop

After having a baby, there are some expected changes in pelvic floor function. However, tearing of the pelvic floor, having a large baby and needing a vacuum or forceps to deliver the baby put women at risk for having pelvic floor disorders. Our study aims to see if, in women who had a high risk for pelvic floor disorders, a pelvic floor education workshop four weeks after delivery can improve pelvic floor disorders compared to those that did not have a workshop.

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Key information

Age range

18 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Hamilton Health Sciences, Hamilton, Ontario, Canada

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About this study

There is compelling evidence for the need for perineal education and care, especially in women who have recognized risk factors. For example, 30-50% of women who have a clinically recognized risk factor report anal incontinence, fecal urgency, dyspareunia and perineal pain. Despite this, a study found that less than 50% of women with anal incontinence voice those symptoms unless directly asked about them.

Some authors discuss how women may not share these symptoms with their care providers out of the belief that it is a "normal" effect of childbirth. A review of the literature shows that antenatal educational workshops can be an effective means to provide pregnant women with information regarding pelvic floor health, including how modes of delivery impact pelvic floor function. Similarly, antenatal pelvic floor workshops have been found to improve patients' knowledge on pelvic floor health, their practice of pelvic floor muscle exercises and their confidence with these exercises.

To our knowledge, there is no literature exploring the role of a postpartum pelvic floor workshop, on managing perineal and pelvic floor symptoms in women who are identified as being at higher risk of developing pelvic floor dysfunction. Our goal is to develop and assess such a workshop.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Postpartum (ie no more than 4 weeks postpartum at time of group allocation)
  • Vaginal delivery
  • Sustained one or more of the following insults to perineum/pelvic floor
  • Third or fourth degree laceration
  • Vacuum or forceps assisted vaginal delivery
  • Delivery of macrosomic infant ≥4000g)

Exclusion criteria

  • Prior pelvic floor physiotherapy treatment
  • Prior surgical management for pelvic organ prolapse or incontinence
  • Unable to understand English
  • Caesarean delivery
  • Concerns for patient sensitivity - eg if team is aware of neonatal demise, neonate unwell in NICU etc

Treatment and study plan

Pelvic floor workshop

Behavioral

Physiotherapist-led workshop on managing pelvic floor symptoms

Primary outcomes

  1. Pelvic floor distress inventory

    Time frame: Differences between groups in the change in score from beginning of study to 3 months post-partum

    Survey on symptoms of pelvic floor distress

  2. Pelvic floor distress inventory

    Time frame: Differences between groups in the change in score from beginning of study to 6 months post-partum

    Survey on symptoms of pelvic floor distress

  3. Pelvic floor distress inventory

    Time frame: Differences between groups in the change in score from beginning of study to 12 months post-partum

    Validated survey on symptoms of pelvic floor distress

Secondary outcomes

  1. Adherence to pelvic floor exercises

    Time frame: From beginning of study to 12 months post-partum

    Investigator generated questions; Difference between groups in proportion who reported adherence to pelvic floor exercises

  2. Seeking medical care for pelvic floor symptoms

    Time frame: from beginning of study to 12 months post-partum.

    Investigator generated questions: Difference between groups in proportion who reported seeking medical care for their symptoms

Sponsors and collaborators

Lead sponsor

Hamilton Health Sciences Corporation

Other

Registry information

Official study title

A Randomized Trial: Can a Postpartum Pelvic Floor Education Workshop in a High-Risk Population Improve Pelvic Floor Symptoms?

Acronym: PPFW

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Feb 15, 2021
Registry last updated
Jan 17, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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