Evaluating the Feasibility of a Web-App for Pelvic Floor Health in Pregnant Women in the Ferrol Health Area: the WaPRUIN Study (WaPRUIN)

January 22, 2025 updated by: Raquel Iglesias Méndez, Universidad de Oviedo

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

Not yet recruiting

Study Type

Observational

Enrollment (Estimated)

212

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

    • A Coruña
      • Ferrol, A Coruña, Spain, 15405

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

The study population consists of pregnant women from the Ferrol Health Area who receive prenatal care in the Gynecology and Obstetrics Department at Hospital Arquitecto Marcide.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

March 10, 2025

Primary Completion (Estimated)

November 1, 2025

Study Completion (Estimated)

November 1, 2025

Study Registration Dates

First Submitted

January 22, 2025

First Submitted That Met QC Criteria

January 22, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 22, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

The decision on whether to share individual participant data (IPD) will be made after the completion of the study and analysis of results. Further updates will be provided when available.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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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