NCT07104292

Pelvic Floor Muscle Training During Pregnancy

PFMT During Pregnancy - Its Implementation and Effects on Pelvic Floor Disorders, Sexual Function and Obstetric Outcomes: a Hybrid Type 1 Design Randomised Controlled Trial

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 734 (estimated)
• Sponsor: University of Southern Denmark · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

The project seeks to investigate effectiveness of PFMT during pregnancy.

Detailed 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.

Conditions

• Pelvic Floor
• Urinary Incontinence
• Anal Incontinence
• Pelvic Organ Prolapse
• Sexual Dysfunction

Interventions

Type	Name	Description
BEHAVIORAL	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.
BEHAVIORAL	Standard care	Standard care

Timeline

• Start date: 2025-10-27
• Primary completion: 2027-08-01
• Completion: 2028-08-01
• First posted: 2025-08-05
• Last updated: 2025-11-28

Locations

1 site across 1 country: Denmark