PregnancyWaPRUINNCT06797323
Evaluating the Feasibility of a Web-App for Pelvic Floor Health in Pregnant Women in the Ferrol Health Area: the WaPRUIN Study
An observational study of Pregnancy and Pelvic Floor Disorder, run by Universidad de Oviedo at 1 site in Spain.
Trial summary
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… Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Pregnancy, Pelvic Floor Disorder
- What is being tested?
- Web-Based Application for Pelvic Floor Health
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 212 participants
- Where
- 1 siteSpain
- Study dates
- 10 Mar 2025to Nov 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site
Arquitecto Marcide Hospital
Ferrol, A Coruña, 15405
Gynecology and Obstetrics Department, +34 981 334 011, Raquel.Iglesias.Mendez@sergas.es
About this study
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.
- Conditions
- Pregnancy, Pelvic Floor Disorder
- Being tested
- Web-Based Application for Pelvic Floor Health
- Medical subject headings
- Pelvic Floor Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Web-Based Application for Pelvic Floor HealthBehavioural
A user-friendly web application designed to provide educational resources, exercises, and interactive tools aimed at improving pelvic floor health in pregnant women.
| Study group | Role | What they receive |
|---|---|---|
| Pregnant women | Not described Receives: Behavioral: Web-Based Application for Pelvic Floor Health |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of the Web-App Usage
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.
Measured: From enrollment to the end of web application use at 8 weeks
Secondary outcomes (5)
Frequency of Web-App Use
To analyze the frequency of use of the web-app by the participants during the study.
Measured: From enrollment to the end of web application use at 8 weeks
Relationship Between Usability and Participant Characteristics
To describe the relationship between the feasibility and usability of the web-app and the personal characteristics of the participants.
Measured: From enrollment to the end of web application use at 8 weeks
Knowledge Improvement on Pelvic Floor Health
To evaluate whether the use of the web-app contributes to an increase in knowledge regarding pelvic floor health during pregnancy among participants.
Measured: From enrollment to the end of web application use at 8 weeks
Effectiveness in Encouraging Pelvic Floor Exercises
To determine the effectiveness of the web-app in promoting the practice of pelvic floor exercises among participants.
Measured: From enrollment to the end of web application use at 8 weeks
Prevalence of Urinary Incontinence at Inclusion
To describe the percentage of pregnant women presenting urinary incontinence at the time of enrolment in the study
Measured: At baseline (time of enrollment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2025
- Study start10 Mar 2025 (estimated)
- Primary completionNov 2025 (estimated)
- Study completionNov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PregnancyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 212 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidad de Oviedo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Raquel Iglesias Méndez, Universidad de Oviedo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06797323
- Sponsor's protocol ID
- 2023/291
- Acronym
- WaPRUIN
- Status last verified
- Jan 2025
- First submitted
- 22 Jan 2025
- Last updated
- 28 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: 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.
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Feasibility of a Web-App for Pelvic Floor Health in Pregnant Women in the Ferrol Health Area: the WaPRUIN Study
- ClinicalTrials.gov ID
- NCT06797323
- Acronym / sponsor ID
- WaPRUIN / 2023/291
- Conditions
- Pregnancy, Pelvic Floor Disorder
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 212 participants (estimated)
- Lead sponsor
- Universidad de OviedoUniversity, hospital or other
- Study start
- 10 Mar 2025 (estimated)
- Primary completion
- Nov 2025 (estimated)
- Study completion
- Nov 2025 (estimated)
- First posted
- 28 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pregnant women | – | Behavioral: Web-Based Application for Pelvic Floor Health |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Web-Based Application for Pelvic Floor HealthA user-friendly web application designed to provide educational resources, exercises, and interactive tools aimed at improving pelvic floor health in pregnant women. | Behavioural | Pregnant women |
Primary outcome
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.
5 secondary outcomes
Frequency of Web-App Use
Time frame: 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
Knowledge Improvement on Pelvic Floor Health
Time frame: 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
Prevalence of Urinary Incontinence at Inclusion
Time frame: At baseline (time of enrollment)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2025.
- Individual participant dataSharing planned: Undecided. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pregnancy and Pelvic Floor Disorder, run by Universidad de Oviedo at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 28 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Raquel Iglesias-Méndez (+34 626754452, medicinaraquel@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of the Web-App Usage (time frame: From enrollment to the end of web application use at 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jan 2025.