Pelvic floor muscle training for first-time pregnant women
PFMT During Pregnancy - Its Implementation and Effects on Pelvic Floor Disorders, Sexual Function and Obstetric Outcomes: a Hybrid Type 1 Design Randomised Controlled Trial
This project will test whether a home-based, app-accessible pelvic floor exercise program helps first-time pregnant women reduce pelvic floor problems during pregnancy and after birth.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 734 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | University of Southern Denmark Academic / other |
| Locations | 1 site (Aabenraa, Southern Denmark) |
| Trial ID | NCT07104292 on ClinicalTrials.gov |
What this trial studies
First-time pregnant women in their first trimester are recruited from obstetrics departments in the Southern Denmark Region and randomized to either a motivation-informed pelvic floor muscle training (PFMT) program or usual care. The intervention is delivered electronically for home use and includes features to promote exercise start, engagement, and adherence, with continuation encouraged after birth. Data on pelvic floor disorders are collected at baseline, each trimester, and at six weeks, three months, and six months postpartum, while obstetric outcomes are extracted from electronic patient records. Implementation outcomes including motivation and acceptability are measured by questionnaires and telephone interviews during pregnancy and postpartum.
Who should consider this trial
Good fit: Ideal participants are first-time pregnant women (para 0) in the first trimester (up to 12+6 weeks), who read Danish or English and have a smartphone or computer/tablet to access the program.
Not a fit: Women with prior pregnancies beyond 16 weeks, severe psychiatric illness, active substance abuse, acute social crises, limited capacity for consent, or no access to digital devices are unlikely to benefit from this intervention.
Why it matters
Potential benefit: If successful, the program could lower rates of urinary and anal incontinence and reduce pelvic organ prolapse symptoms after childbirth by improving pelvic floor strength and exercise adherence.
How similar studies have performed: Previous randomized trials have shown pelvic floor muscle training can reduce postpartum urinary incontinence, but motivation-focused, digitally delivered programs during pregnancy are less well studied.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Aabenraa, Southern Denmark
- Sygehus Sønderjylland — Aabenraa, Southern Denmark, Denmark (Recruiting)
Study contacts
- Study coordinator: Greta Puriene
- Email: greta.puriene@rsyd.dk
- Phone: +4571638335
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.