Pelvic Floor Muscle Training During Pregnancy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: PFMT, Standard care.
- Who it may be relevant to
- Registry conditions: Pelvic Floor, Urinary Incontinence, Anal Incontinence, Pelvic Organ Prolapse. Basic parameters: from 18 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Denmark
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
PFMT During Pregnancy - Its Implementation and Effects on Pelvic Floor Disorders, Sexual Function and Obstetric Outcomes: a Hybrid Type 1 Design Randomised Controlled Trial
Overview
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.
Interventions
- 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
Primary outcome measures
- Urinary incontinence (UI) incidence at 3 months postpartum [Time frame: At 3 months follow-up after giving birth]
Secondary outcome measures (12)
- Urinary incontinence at the 1st trimester of pregnancy [Time frame: At baseline, during the 1st trimester of pregnancy (gestational age (GA) up to 12 weeks +6 days)]
- Urinary incontinence at the 2nd trimester of pregnancy [Time frame: At the follow-up at Gestational age 26 weeks and 0 days]
- Urinary incontinence incidence at the 3rd trimester of pregnancy [Time frame: At the follow-up at Gestational Age 36 weeks and 0 days]
- Urinary incontinence incidence at 6 weeks postpartum [Time frame: At the follow-up at 6 weeks postpartum]
- Anal incontinence (AI) incidence at inclusion, during the 1st trimester of pregnancy [Time frame: At baseline, during the 1st trimester of pregnancy (gestational age (GA) up to 12 weeks +6 days)]
- Anal incontinence (AI) in the 2nd trimester of pregnancy [Time frame: At the follow-up at Gestational Age 26 weeks and 0 days]
- Anal incontinence (AI) incidence in the 3rd trimester of pregnancy [Time frame: At the follow-up at Gestational Age 36 weeks and 0 days]
- Anal incontinence (AI) incidence at 6 weeks postpartum [Time frame: At the follow-up at 6 weeks postpartum]
- Anal incontinence (AI) incidence at 3 months postpartum [Time frame: At the follow-up at 3 months postpartum]
- Anal incontinence (AI) incidence at 6 months postpartum [Time frame: At the follow-up at 6 months postpartum]
- Sexual dysfunction incidence at inclusion, during the 1st trimester of pregnancy [Time frame: At baseline, during the 1st trimester of pregnancy (gestational age (GA) up to 12 weeks +6 days)]
- Sexual dysfunction incidence at inclusion, during the 2nd trimester of pregnancy [Time frame: At the follow-up at Gestational Age 26weeks and 0 days]
Eligibility 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Prevention
Study locations
Denmark · 1 center
- Sygehus Sønderjylland — Aabenraa
Identifiers
NCT: NCT07104292 · SHS-KS-06-2025