NCT06797323

Brief 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 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
212

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2025

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 22, 2025

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 28, 2025

Completed
1 month until next milestone

Study Start

First participant enrolled

March 10, 2025

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2025

Completed
Last Updated

January 28, 2025

Status Verified

January 1, 2025

Enrollment Period

8 months

First QC Date

January 22, 2025

Last Update Submit

January 22, 2025

Conditions

PregnancyPelvic Floor Disorder

Outcome Measures

Primary Outcomes (1)

  • 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.

    From enrollment to the end of web application use at 8 weeks

Secondary Outcomes (5)

  • Frequency of Web-App Use

    From enrollment to the end of web application use at 8 weeks

  • Relationship Between Usability and Participant Characteristics

    From enrollment to the end of web application use at 8 weeks

  • Knowledge Improvement on Pelvic Floor Health

    From enrollment to the end of web application use at 8 weeks

  • Effectiveness in Encouraging Pelvic Floor Exercises

    From enrollment to the end of web application use at 8 weeks

  • Prevalence of Urinary Incontinence at Inclusion

    At baseline (time of enrollment)

Study Arms (1)

Pregnant women

Behavioral: Web-Based Application for Pelvic Floor Health

Interventions

Web-Based Application for Pelvic Floor HealthBEHAVIORAL

A user-friendly web application designed to provide educational resources, exercises, and interactive tools aimed at improving pelvic floor health in pregnant women.

Pregnant women

Eligibility Criteria

Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Arquitecto Marcide Hospital

Ferrol, A Coruña, 15405, Spain

Location

MeSH Terms

Conditions

Pelvic Floor Disorders

Condition Hierarchy (Ancestors)

Female Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesPregnancy ComplicationsMale Urogenital Diseases

Central Study Contacts

Raquel Iglesias-Méndez

CONTACT

+34 626754452medicinaraquel@gmail.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD candidate

Study Record Dates

First Submitted

January 22, 2025

First Posted

January 28, 2025

Study Start

March 10, 2025

Primary Completion

November 1, 2025

Study Completion

November 1, 2025

Last Updated

January 28, 2025

Record last verified: 2025-01

Locations

ES(1)