Pelvic Floor Muscle Training During Pregnancy

NCT ID: NCT07104292

Last Updated: 2025-11-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

734 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-10-27

Study Completion Date

2028-08-01

Brief Summary

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The project seeks to investigate effectiveness of PFMT during pregnancy.

Detailed Description

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First-time pregnant women will be recruited through visitations received from family doctors in all obstetrics departments of the Southern Denmark Region. Women will be randomised into two groups: ( Pelvic Floor Muscle Training) PFMT and a control group (standard care). The motivation-informed intervention will tackle both exercise engagement and exercise adherence. The women will receive an easily accessible, home-based PFMT program electronically in which they will be motivated to start and engage during pregnancy with continuity after birth. The data regarding pelvic floor disorders will be obtained at baseline, follow-ups once every trimester of pregnancy, as well as six weeks, three months, and six months postpartum with further follow-up after the study. The data regarding obstetric outcomes will be collected from electronic patient records. For evaluation of implementation process, data regarding motivation and training acceptability will be obtained via questionnaire at the baseline and at follow-up together with telephonically interviews during pregnancy and postpartum.

Conditions

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Pelvic Floor Urinary Incontinence Anal Incontinence Pelvic Organ Prolapse Sexual Dysfunction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Pelvic Floor Muscle Training (PFMT)

A Danish professional pelvic floor physiotherapist together with a midwife and an urogynecologist have created a free of charge training program, which is easily accessible via a danish website "www.kvindekrop.dk" or via the app "Pelvic FloorTrainer". The women will receive an easily accessible, home-based PFMT program electronically in which they will be motivated to start and engage during pregnancy with continuity after birth.

Group Type EXPERIMENTAL

PFMT

Intervention Type BEHAVIORAL

The motivation-informed intervention will tackle both exercise engagement and exercise adherence. Participating women will be introduced to the app and its videos following training. The participants will be introduced not only to muscle training, but also to muscle relaxation. The training will be recommended three to four times a week during pregnancy with further continuity after giving birth.

Standard care

The control group will receive routine care - recommendation to do the training without any further instructions.

Group Type PLACEBO_COMPARATOR

Standard care

Intervention Type BEHAVIORAL

Standard care

Interventions

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PFMT

The motivation-informed intervention will tackle both exercise engagement and exercise adherence. Participating women will be introduced to the app and its videos following training. The participants will be introduced not only to muscle training, but also to muscle relaxation. The training will be recommended three to four times a week during pregnancy with further continuity after giving birth.

Intervention Type BEHAVIORAL

Standard care

Standard care

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Woman in the 1st trimester of pregnancy (up to 12+6 weeks of gestation)
* Para 0 (no previous birth or pregnancy \> 16 weeks of gestation)
* Understands, writes, and reads fluently in Danish or English
* Has a smart phone or computer/tablet to reach the training program

Exclusion Criteria

* Severe psychiatric illness (e.g. schizophrenia, bipolar disorder, severe depression or anxiety)
* Active substance abuse
* Acute social crises (e.g. homelessness, ongoing domestic violence, severe financial instability, lack of social support)
* Women with limited capacity to provide informed consent (due to cognitive impairment or language barriers)
* Previous pregnancy of \> 16 weeks of gestation
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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University of Southern Denmark

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jan Stener Jørgensen

Role: STUDY_CHAIR

University Hospital of Southern Denmark

Locations

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Sygehus Sønderjylland

Aabenraa, Southern Denmark, Denmark

Site Status RECRUITING

Countries

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Denmark

Central Contacts

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Greta Puriene

Role: CONTACT

+4571638335

Christina Prinds

Role: CONTACT

+4565504953

Other Identifiers

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SHS-KS-06-2025

Identifier Type: -

Identifier Source: org_study_id

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