Pelvic Floor Muscle Training During Pregnancy

University of Southern Denmark (SDU)

Status: Enrolling

Conditions: Anal Incontinence; Pelvic Floor; Sexual Dysfunction; Pelvic Organ Prolapse; Urinary Incontinence

Treatments: Behavioral: PFMT; Behavioral: Standard care

Study type: Interventional

Funder types: Other

Identifiers

NCT07104292

SHS-KS-06-2025

Details and patient eligibility

About

The project seeks to investigate effectiveness of PFMT during pregnancy.

Full description

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.

Enrollment: 734 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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734 participants in 2 patient groups, including a placebo group

Pelvic Floor Muscle Training (PFMT)

Experimental group

Description:

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.

Treatment:

Behavioral: PFMT

Standard care

Placebo Comparator group

Description:

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

Treatment:

Behavioral: Standard care