Trial Outcomes & Findings for Educating Women About Pelvic Floor Disorders During Pregnancy (NCT NCT05440539)
NCT ID: NCT05440539
Last Updated: 2025-06-19
Results Overview
Validated 24 question questionnaire with two sections to test knowledge on pelvic organ prolapse and urinary incontinence. Scored out of 24 with higher scores indicating an increase in knowledge. Minimum value: 0, Maximum value: 24. Higher scores mean better outcome. Lower scores mean worse outcome. This was administrated at time of recruitment and again at 6 weeks postpartum.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
120 participants
Primary outcome timeframe
< 5 minutes
Results posted on
2025-06-19
Participant Flow
Recruited between August 2020 and Sept 2021. Patients were identified via medical records and approached in an obstetrics clinic at a single institution.
Participants were excluded if they were not english speaking or were unable to give consent due to being a minor or unable to provide consent.
Participant milestones
| Measure |
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.
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.
|
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.
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.
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.
|
|---|---|---|
|
Overall Study
STARTED
|
61
|
59
|
|
Overall Study
COMPLETED
|
54
|
51
|
|
Overall Study
NOT COMPLETED
|
7
|
8
|
Reasons for withdrawal
| Measure |
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.
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.
|
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.
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.
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.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
4
|
4
|
|
Overall Study
Fetal demise, no longer pregnant
|
3
|
4
|
Baseline Characteristics
Educating Women About Pelvic Floor Disorders During Pregnancy
Baseline characteristics by cohort
| Measure |
Written Group
n=61 Participants
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.
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.
|
Workshop Group
n=59 Participants
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.
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.
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.
|
Total
n=120 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
32 Years
n=93 Participants
|
32 Years
n=4 Participants
|
32 Years
n=27 Participants
|
|
Sex: Female, Male
Female
|
61 Participants
n=93 Participants
|
59 Participants
n=4 Participants
|
120 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
White
|
28 Participants
n=93 Participants
|
32 Participants
n=4 Participants
|
60 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
20 Participants
n=93 Participants
|
13 Participants
n=4 Participants
|
33 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Black
|
8 Participants
n=93 Participants
|
7 Participants
n=4 Participants
|
15 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Asian
|
4 Participants
n=93 Participants
|
7 Participants
n=4 Participants
|
11 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Other (unspecified)
|
1 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
|
Region of Enrollment
United States
|
61 participants
n=93 Participants
|
59 participants
n=4 Participants
|
120 participants
n=27 Participants
|
|
Income Level
<10,000
|
1 Participants
n=93 Participants
|
5 Participants
n=4 Participants
|
6 Participants
n=27 Participants
|
|
Income Level
10,000-49,999
|
6 Participants
n=93 Participants
|
5 Participants
n=4 Participants
|
11 Participants
n=27 Participants
|
|
Income Level
50,000-100,000
|
16 Participants
n=93 Participants
|
13 Participants
n=4 Participants
|
29 Participants
n=27 Participants
|
|
Income Level
>100,000
|
38 Participants
n=93 Participants
|
36 Participants
n=4 Participants
|
74 Participants
n=27 Participants
|
|
Gravida
|
1 Number of Pregnancies
n=93 Participants
|
2 Number of Pregnancies
n=4 Participants
|
2 Number of Pregnancies
n=27 Participants
|
|
Para
|
1 Number of Deliveries
n=93 Participants
|
1 Number of Deliveries
n=4 Participants
|
1 Number of Deliveries
n=27 Participants
|
|
Pre-Pregnancy BMI
|
27.1 kg/m2
n=93 Participants
|
25.5 kg/m2
n=4 Participants
|
26.2 kg/m2
n=27 Participants
|
|
Married
|
47 Participants
n=93 Participants
|
50 Participants
n=4 Participants
|
97 Participants
n=27 Participants
|
|
Education Level
High School
|
3 Participants
n=93 Participants
|
7 Participants
n=4 Participants
|
10 Participants
n=27 Participants
|
|
Education Level
College
|
32 Participants
n=93 Participants
|
25 Participants
n=4 Participants
|
57 Participants
n=27 Participants
|
|
Education Level
Graduate School
|
26 Participants
n=93 Participants
|
27 Participants
n=4 Participants
|
53 Participants
n=27 Participants
|
PRIMARY outcome
Timeframe: < 5 minutesValidated 24 question questionnaire with two sections to test knowledge on pelvic organ prolapse and urinary incontinence. Scored out of 24 with higher scores indicating an increase in knowledge. Minimum value: 0, Maximum value: 24. Higher scores mean better outcome. Lower scores mean worse outcome. This was administrated at time of recruitment and again at 6 weeks postpartum.
Outcome measures
| Measure |
Written Group
n=61 Participants
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.
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.
|
Workshop Group
n=59 Participants
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.
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.
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.
|
|---|---|---|
|
Prolapse and Incontinence Knowledge Questionnaire (PIKQ)
Post-PIKQ
|
21 score on a scale
Interval 19.0 to 23.0
|
21 score on a scale
Interval 17.0 to 22.0
|
|
Prolapse and Incontinence Knowledge Questionnaire (PIKQ)
Pre-PIKQ
|
17 score on a scale
Interval 14.0 to 22.0
|
17 score on a scale
Interval 13.0 to 20.0
|
SECONDARY outcome
Timeframe: < 5 minutesValidated questionnaire measuring presence and degree of both of pelvic floor disorder symptoms. Three sub sections with a possible score of 100 for each sub section. Scaled score is a combination of the 3 sub section scores for a total possible score of 300. Higher scores indicates increased symptom bother. Minimum value: 0, Maximum value: 300. Higher scores mean better outcome. Lower scores mean worse outcome. This was administrated at time of recruitment and again at 6 weeks postpartum.
Outcome measures
| Measure |
Written Group
n=61 Participants
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.
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.
|
Workshop Group
n=59 Participants
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.
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.
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.
|
|---|---|---|
|
Pelvic Floor Distress Inventory (PFDI-20)
Pre-PFDI
|
29.17 score on a scale
Interval 12.5 to 64.58
|
36.47 score on a scale
Interval 17.71 to 62.5
|
|
Pelvic Floor Distress Inventory (PFDI-20)
Post-PFDI
|
14.58 score on a scale
Interval 0.0 to 25.0
|
9.89 score on a scale
Interval 3.13 to 22.92
|
SECONDARY outcome
Timeframe: < 10 minutesPopulation: Only the workshop group were included in the phone interview portion of the study as they experienced both interventions: written handouts and virtual workshop.
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.
Outcome measures
| Measure |
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.
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.
|
Workshop Group
n=34 Participants
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.
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.
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.
|
|---|---|---|
|
Phone Interview
Preferred workshop format
|
—
|
20 Participants
|
|
Phone Interview
Preferred written format
|
—
|
14 Participants
|
Adverse Events
Written Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Workshop Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place