- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06797323
Evaluating the Feasibility of a Web-App for Pelvic Floor Health in Pregnant Women in the Ferrol Health Area: the WaPRUIN Study (WaPRUIN)
This study aims to evaluate the feasibility of using a web-based application to improve pelvic floor health in pregnant women within the Ferrol Health Area, Spain. The intervention involves providing educational resources through a user-friendly digital platform, designed to empower women with knowledge about pelvic floor function and techniques for strengthening it during pregnancy.
The study hypothesizes that a web-based educational tool can effectively increase awareness, engagement, and adherence to pelvic floor exercises among pregnant women, thereby contributing to improved maternal health outcomes. Participants will include pregnant women from the Ferrol Health Area, who will voluntarily use the application during their pregnancy.
The study will assess outcomes related to usability, accessibility, and participant satisfaction with the application, as well as any improvements in pelvic floor-related health indicators. By addressing an important gap in maternal health education, this project has the potential to provide an innovative and scalable solution to enhance prenatal care.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Raquel Iglesias-Méndez
- Phone Number: +34 626754452
- Email: medicinaraquel@gmail.com
Study Locations
-
-
A Coruña
-
Ferrol, A Coruña, Spain, 15405
- Arquitecto Marcide Hospital
-
Contact:
- Gynecology and Obstetrics Department
- Phone Number: +34 981 334 011
- Email: Raquel.Iglesias.Mendez@sergas.es
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Pregnant women attending their first prenatal consultation at the Hospital Arquitecto Marcide.
- Pregnant women who voluntarily consent to participate in the study by signing the informed consent form.
Exclusion Criteria:
- Pregnant women who do not have proficiency in the Spanish language.
- Limitations in using the web-app (e.g., physical, cognitive, or technological barriers).
- Lack of internet access.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Pregnant women
|
A user-friendly web application designed to provide educational resources, exercises, and interactive tools aimed at improving pelvic floor health in pregnant women.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Feasibility of the Web-App Usage
Time Frame: From enrollment to the end of web application use at 8 weeks
|
To evaluate the feasibility and usability of the "PelviEduca" web-app, which is designed to improve knowledge about pelvic floor health and related conditions during pregnancy in pregnant women within the Ferrol Health Area.
|
From enrollment to the end of web application use at 8 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Frequency of Web-App Use
Time Frame: From enrollment to the end of web application use at 8 weeks
|
To analyze the frequency of use of the web-app by the participants during the study.
|
From enrollment to the end of web application use at 8 weeks
|
|
Relationship Between Usability and Participant Characteristics
Time Frame: From enrollment to the end of web application use at 8 weeks
|
To describe the relationship between the feasibility and usability of the web-app and the personal characteristics of the participants.
|
From enrollment to the end of web application use at 8 weeks
|
|
Knowledge Improvement on Pelvic Floor Health
Time Frame: From enrollment to the end of web application use at 8 weeks
|
To evaluate whether the use of the web-app contributes to an increase in knowledge regarding pelvic floor health during pregnancy among participants.
|
From enrollment to the end of web application use at 8 weeks
|
|
Effectiveness in Encouraging Pelvic Floor Exercises
Time Frame: From enrollment to the end of web application use at 8 weeks
|
To determine the effectiveness of the web-app in promoting the practice of pelvic floor exercises among participants.
|
From enrollment to the end of web application use at 8 weeks
|
|
Prevalence of Urinary Incontinence at Inclusion
Time Frame: At baseline (time of enrollment)
|
To describe the percentage of pregnant women presenting urinary incontinence at the time of enrolment in the study
|
At baseline (time of enrollment)
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2023/291
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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