About the Project 

Purpose 

The aim of the project is to understand, motivate, and facilitate the implementation of pelvic floor muscle training for pregnant women. The project seeks to implement PFMT in a real-world setting in a cost-effective and motivating way using an existing digital PFMT program. At the same time, it will evaluate whether the program is effective in preventing pelvic floor disorders, improving sexual function, and enhancing birth outcomes. 

Method and Practical Information 

The project is a randomized controlled trial (RCT) involving 740 first-time pregnant women. You will be randomly assigned to either a training group or a control group. 

If you are in the training group, you will be asked to perform pelvic floor exercises using the “Pelvic Floor Trainer” app 3-4 times per week throughout your pregnancy and after childbirth. There are no risks associated with participation. The training is safe and adapted for pregnant women. Regardless of group, you will be asked to complete questionnaires during and after pregnancy. 

Data collected about you

• Contact information: CPR number (for e-Boks communication), phone number
• From pregnancy records: Age, marital status, pre-pregnancy BMI, due date calculations, fertility treatment, relevant medical conditions, medications, surgeries, previous pregnancies, smoking, alcohol, and other substance use.
• From patient journal: at the beginning of pregnancy (multiple pregnancy if applicable, gestational age at inclusion), during pregnancy (any pregnancy complications) and after birth (duration of labor, mode of delivery, fetal position, child weight, episiotomy, perineal tears and their classification).
• From questionnaires: urinary incontinence (ICIQ-UI SF), anal incontinence and pelvic organ prolapse symptoms (PFDI-20), sexual function (FSFI-6), training frequency, motivation, and knowledge about pelvic floor training.
• From interviews (if you consent later): Your thoughts on the training program, motivation, and experience with the implementation process. 

How the information is collected 

• Upon consent, information will be collected from your pregnancy records.
• Questionnaires will be sent at the start, during the 2nd and 3rd trimesters, and at 6 weeks, 3 months, and 6 months after giving birth.
• If you will be assigned to a training group, will you be asked to fill weekly diary via app “MyCap” about how many times you did the training.
• Medical record data on birth outcomes will be collected after delivery.
• In case of your consent, an interview will be organized via telephone or Teams, depending on your preferences.
• If you consent to extended participation, a final questionnaire will be sent 1 year postpartum. 

Data protection and confidentiality 

• Your data will be treated confidentially and stored securely via OPEN – a platform that complies with current data protection regulations.
• You can read more about your rights on the website of the Danish Data Protection Agency, which provides a guide on data subject rights: Registreredes rettigheder.pdf (datatilsynet.dk).
• The information will be used solely for research purposes and will not be shared with unauthorized individuals.
• Your rights and anonymity are protected in accordance with applicable laws and ethical guidelines. 

Contact information 

If you have questions, you are welcome to contact:

Greta Puriene
Project-responsible medical doctor, PhD student

E-mail: greta.puriene@rsyd.dk
Work phone number: 40 24 09 64  (working days, between 9:00-14:00) 
Institution: Hospital Sønderjylland, Department of Gynecology and Obstetrics 

Others researchers in project group:

• Christina Prinds, associate professor, midwife
• Finn Lauszus, associate professor, gynecologist
• Jan Stener Jørgensen, professor in obstetrics
• Nikos Ntoumanis, professor in motivational science