Actively Recruiting
PFMT During Pregnancy: A Randomized Controlled Trial Evaluating Effects on Pelvic Floor Disorders, Sexual Function, and Obstetric Outcomes
Led by University of Southern Denmark · Updated on 2025-11-28
734
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to study pelvic floor muscle training (PFMT) during pregnancy in first-time pregnant women. It evaluates the effects of a home-based PFMT program on pelvic floor disorders, sexual function, and obstetric outcomes. The study is a randomized controlled trial that compares an electronic, motivation-informed PFMT program to standard care, focusing on exercise engagement and adherence during pregnancy and continuing after birth. Participants are randomly assigned to one of two groups: the PFMT group receives access to a free, easily accessible training program via a Danish website or app, which includes muscle training and relaxation exercises recommended three to four times a week during pregnancy and postpartum. The control group receives standard care with routine recommendations but no structured guidance. The study includes follow-ups during each trimester of pregnancy and at six weeks, three months, and six months postpartum, with additional longer-term follow-up. Women in the study will complete questionnaires on pelvic floor disorders, motivation, and training acceptance at baseline and follow-ups, along with telephone interviews during pregnancy and postpartum. Medical data on obstetric outcomes will be collected from electronic patient records. The main outcome measured is the incidence of urinary incontinence at three months postpartum, with many secondary outcomes including urinary and anal incontinence, sexual dysfunction, pelvic organ prolapse, and details of delivery. Weekly questionnaires on training adherence will be collected from baseline to six months postpartum.
CONDITIONS
Brief Title
Pelvic Floor Muscle Training During Pregnancy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Woman in the 1st trimester of pregnancy (up to 12 weeks and 6 days gestation)
- First pregnancy beyond 16 weeks (no previous birth or pregnancy > 16 weeks)
- Able to understand, write, and read Danish or English
- Has access to a smartphone, computer, or tablet to use the training program
You will not qualify if you...
- Severe psychiatric illness such as schizophrenia, bipolar disorder, severe depression, or anxiety
- Active substance abuse
- Acute social crises including homelessness, ongoing domestic violence, severe financial instability, or lack of social support
- Limited ability to provide informed consent due to cognitive impairment or language barriers
- Previous pregnancy beyond 16 weeks gestation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - Up to 12 weeks and 6 days gestation
Participants are screened for eligibility to participate in the trial.
1 visit (in-person or remote) at first trimester
Duration - From screening through 6 months postpartum
Participants in the PFMT group will follow a home-based pelvic floor muscle training program using an app or website, training three to four times a week during pregnancy and continuing after birth. The control group will receive standard care with recommendations but no additional training instructions.
Follow-up visits once every trimester during pregnancy and at 6 weeks, 3 months, and 6 months postpartum
Duration - From baseline through study completion
Participant data on pelvic floor disorders, sexual function, and obstetric outcomes are collected through questionnaires, telephone interviews, and electronic patient records throughout pregnancy and postpartum.
Weekly questionnaires from baseline to 6 months postpartum; telephone interviews during pregnancy and postpartum; clinical data collected continuously
Trial Site Locations
Total: 1 location
1
Sygehus Sønderjylland
Aabenraa, Southern Denmark, Denmark, 6200
Actively Recruiting
Research Team
G
Greta Puriene
C
Christina Prinds
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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