Educating Women About Pelvic Floor Disorders During Pregnancy

Sponsor
The Methodist Hospital Research Institute (Other)
Overall Status
Completed
CT.gov ID
NCT05440539
Collaborator
(none)
120
1
2
13.3
9

Study Details

Study Description

Brief Summary

The purpose of this study is to assess the increase in knowledge of pregnant patients regarding pelvic floor disorders when comparing two educational interventions: written handouts vs interactive workshops.

Condition or Disease Intervention/Treatment Phase
  • Other: Written Handouts
  • Other: Interactive Workshop
N/A

Detailed Description

Pelvic floor disorders (PFDs) are common and significantly affect the quality of life of many women as they age. Pregnancy has been identified as a major risk factor for developing PFDs later in life. Educating women about PFDs is essential to ensuring that they present to care in a timely manner. No study has investigated different education tools during pregnancy. The proposed study is a randomized controlled trial in pregnant patients comparing two educational tools: written materials about PFDs versus an educational workshops led by pelvic floor physical therapists (PFPTs). Pregnant patients will be recruited in the first and second trimester and randomized at that time. Knowledge will be assessed at baseline and again 6 weeks postpartum using the validated Prolapse and Incontinence Knowledge Questionnaire. Secondary outcomes will be evaluating referral patterns to urogynecology and to PFPTs from general OBGYNs and assessing any pelvic floor symptoms with the pelvic floor disability index (PFDI-20) at baseline and at 6 weeks postpartum.

Study Design

Study Type:
Interventional
Actual Enrollment :
120 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Randomized clinical trialRandomized clinical trial
Masking:
None (Open Label)
Primary Purpose:
Other
Official Title:
Educating Women About Pelvic Floor Disorders During Pregnancy From the 1st to the "4th Trimester": A Randomized Clinical Trial
Actual Study Start Date :
Aug 1, 2020
Actual Primary Completion Date :
May 5, 2021
Actual Study Completion Date :
Sep 10, 2021

Arms and Interventions

Arm Intervention/Treatment
Experimental: Written Group

Participants received only written handouts with information about pelvic floor disorders, including risk factors, prevention strategies, and information about possible treatments. They receive these handouts at the time of recruitment during pregnancy and again after delivery.

Other: Written Handouts
The written materials were generated using the collaboration of healthcare communication specialists to generate content that is tailored to a younger age demographic of childbearing age regarding their risk of developing a pelvic floor disorder and what can be done to prevent or treat them in the future.

Experimental: Workshop Group

Participants received written handouts and attend a virtual interactive workshop with information about pelvic floor disorders, including risk factors, prevention strategies, and information about possible treatments. They receive the handouts at the time of recruitment during pregnancy and again after delivery. The workshop is conducted prior to completion of pregnancy.

Other: Written Handouts
The written materials were generated using the collaboration of healthcare communication specialists to generate content that is tailored to a younger age demographic of childbearing age regarding their risk of developing a pelvic floor disorder and what can be done to prevent or treat them in the future.

Other: Interactive Workshop
Participants logged onto a virtual meeting platform and listened to a live 20 minute presentation by a pelvic floor physical therapist followed by time for questions, which were answered live. Participants anonymity was maintained by not allowing participants to view each other's name and disabling sharing of video feeds.

Outcome Measures

Primary Outcome Measures

  1. Prolapse and Incontinence Knowledge Questionnaire (PIKQ) [< 5 minutes]

    Validated 24 question questionnaire with two sections to test knowledge on pelvic organ prolapse and urinary incontinence

Secondary Outcome Measures

  1. Pelvic Floor Distress Inventory (PFDI-20) [< 5 minutes]

    Validated questionnaire measuring presence and degree of both of pelvic floor disorder symptoms.

  2. Phone Interview [< 10 minutes]

    One-on-one phone interviews conducted with participants in the workshop education group who experienced both educational tools. A research team member called them after completion of the study and conducted a brief 3 question interview to understand their opinion of the educational tools.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • Pregnant (prior to 27 weeks gestation)

  • English speaking

  • Greater than 18 years old

Exclusion Criteria:
  • Non-english speaking

  • unable to provide informed consent

Contacts and Locations

Locations

Site City State Country Postal Code
1 Houston Methodist Hospital Houston Texas United States 77030

Sponsors and Collaborators

  • The Methodist Hospital Research Institute

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
The Methodist Hospital Research Institute
ClinicalTrials.gov Identifier:
NCT05440539
Other Study ID Numbers:
  • PFD Education in Pregnancy
First Posted:
Jul 1, 2022
Last Update Posted:
Jul 1, 2022
Last Verified:
Jun 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by The Methodist Hospital Research Institute
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 1, 2022