Pelvic floor muscle training for first-time pregnant women
Official title: Antenatal Pelvic Floor Muscle Training in Nulliparous Women: A Hybrid Type 1 Randomised Controlled Trial
Run by University of Southern Denmark · NCT07104292 · Data updated 2026-11-12
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
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | Women only |
| Enrollment | 804 (estimated) |
| Sponsor | University of Southern Denmark Academic / other |
| Locations | 1 site (Aabenraa, Southern Denmark) |
| Status | Recruiting |
| Started | October 27, 2025 |
| Main results expected | August 1, 2027 |
| Study ends | August 1, 2028 |
| Registry record updated | October 8, 2026 |
| Trial ID | NCT07104292 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: 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.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * up to 12+6 weeks of gestation to receive invitation and up to 16+0 weeks of gestation to be enrolled * 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 it's running
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Sygehus Sønderjylland
Aabenraa, Southern Denmark, Denmark Recruiting
Study contacts
- Principal investigator: Greta Puriene — Hospital Sønderjylland
- Study coordinator: Greta Puriene
- Email: greta.puriene@rsyd.dk
- Phone: +4571638335
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.