Postpartum Pelvic Floor Workshop

NCT04754984 | Completed

• 1 other identifier: 2020-10672
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Pelvic Floor Disorders; Pelvic Floor; Incompetency; Pelvic Floor Muscle Weakness; Perineum; Injury

Keywords

postpartum perineal education

Outcome Measures

Primary Outcomes (3)

• Pelvic floor distress inventory

  Survey on symptoms of pelvic floor distress

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

• Pelvic floor distress inventory

  Survey on symptoms of pelvic floor distress

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

• Pelvic floor distress inventory

  Validated survey on symptoms of pelvic floor distress

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

Secondary Outcomes (2)

• Adherence to pelvic floor exercises

  From beginning of study to 12 months post-partum

• Seeking medical care for pelvic floor symptoms

  from beginning of study to 12 months post-partum.

Study Arms (2)

Intervention

EXPERIMENTAL

One-time in-person workshop with pelvic floor physiotherapist

Behavioral: Pelvic floor workshop

Control

NO INTERVENTION

Standard care

Interventions

Pelvic floor workshop BEHAVIORAL

Physiotherapist-led workshop on managing pelvic floor symptoms

Intervention

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Hamilton Health Sciences Corporation: lead

Study Sites (2)

Hamilton Health Sciences

Hamilton, Ontario, L8N 3Z5, Canada

Location

St. Joseph's Healthcare Hamilton

Hamilton, Ontario, L8N 4A6, Canada

Location

MeSH Terms

Conditions

Pelvic Floor Disorders; Wounds and Injuries

Condition Hierarchy (Ancestors)

Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Pregnancy Complications; Male Urogenital Diseases

Study Officials

• Ola Malabarey

  Hamilton Health Sciences, McMaster University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: No masking is possible due to the nature of the study.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Gynecologist, Urogynecology speciality

Model Details: Participants will be randomly assigned to the intervention or control group. The intervention group will receive the perineal education workshop. The control group will receive standard care. Both groups will receive surveys at baseline, 3, 6 and 12 months postpartum to assess pelvic floor distress.

Study Record Dates

• First Submitted: February 9, 2021
• First Posted: February 15, 2021
• Study Start: February 1, 2021
• Primary Completion: March 20, 2023
• Study Completion: March 20, 2023
• Last Updated: January 17, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

CA (2)