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NCT Number: NCT07104292

Pelvic Floor Muscle Training During Pregnancy

The project seeks to investigate effectiveness of PFMT during pregnancy.

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Key information

Conditions

Pelvic Floor Anal Incontinence Behavior Behavioral Symptoms Elimination Disorders Encopresis Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Lower Urinary Tract Symptoms Male Urogenital Diseases Mental Disorders Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Pelvic Organ Prolapse Prolapse Sexual Dysfunction Sexual Dysfunction, Physiological Signs and Symptoms Signs and Symptoms, Digestive Urinary Incontinence Urination Disorders Urogenital Diseases Urologic Diseases Urological Manifestations

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Sygehus Sønderjylland

Aabenraa, Southern Denmark, 6200, Denmark

Location status: Recruiting

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

PFMT

Behavioral

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.

Standard Care

Behavioral

Standard care

Primary outcomes

  1. Urinary incontinence (UI) incidence at 3 months postpartum

    Time frame: At 3 months follow-up after giving birth

    International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-UI SF) score between 0 (perfect continence) and 21 (total incontinence).

Secondary outcomes

  1. 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)

    ICIQ-UI SF score between 0-21

  2. Urinary incontinence at the 2nd trimester of pregnancy

    Time frame: At the follow-up at Gestational age 26 weeks and 0 days

    ICIQ-UI SF score between 0-21

  3. Urinary incontinence incidence at the 3rd trimester of pregnancy

    Time frame: At the follow-up at Gestational Age 36 weeks and 0 days

    ICIQ-UI SF score between 0-21

  4. Urinary incontinence incidence at 6 weeks postpartum

    Time frame: At the follow-up at 6 weeks postpartum

    ICIQ-UI SF score between 0-21

  5. 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)

    Colorectal-anal distress inventory 8 (CRAD-8), a part of Pelvic Floor Disability Index (PFDI-20) questionnaire: score calculated by the mean value of all item scores (possible 0-4) multiplied by 25 to obtain the score (range 0 to 100). Answer yes to one of the three questions about anal incontinence will be considered as AI.

  6. Anal incontinence (AI) in the 2nd trimester of pregnancy

    Time frame: At the follow-up at Gestational Age 26 weeks and 0 days

    Colorectal-anal distress inventory 8 (CRAD-8), score 0-100. Answer yes to one of the three questions about anal incontinence will be considered as AI.

  7. Anal incontinence (AI) incidence in the 3rd trimester of pregnancy

    Time frame: At the follow-up at Gestational Age 36 weeks and 0 days

    Colorectal-anal distress inventory 8 (CRAD-8), score 0-100. Answer yes to one of the three questions about anal incontinence will be considered as AI.

  8. Anal incontinence (AI) incidence at 6 weeks postpartum

    Time frame: At the follow-up at 6 weeks postpartum

    Colorectal-anal distress inventory 8 (CRAD-8), score 0-100. Answer yes to one of the three questions about anal incontinence will be considered as AI.

  9. Anal incontinence (AI) incidence at 3 months postpartum

    Time frame: At the follow-up at 3 months postpartum

    Colorectal-anal distress inventory 8 (CRAD-8), score 0-100. Answer yes to one of the three questions about anal incontinence will be considered as AI.

  10. Anal incontinence (AI) incidence at 6 months postpartum

    Time frame: At the follow-up at 6 months postpartum

    Colorectal-anal distress inventory 8 (CRAD-8), score 0-100. Answer yes to one of the three questions about anal incontinence will be considered as AI.

  11. 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)

    Female Sexual Function Index-6 (FSFI-6) score between 2 to 30

  12. Sexual dysfunction incidence at inclusion, during the 2nd trimester of pregnancy

    Time frame: At the follow-up at Gestational Age 26weeks and 0 days

    Female Sexual Function Index-6 (FSFI-6) score between 2 to 30

  13. Sexual dysfunction incidence at inclusion, during the 3rd trimester of pregnancy

    Time frame: At the follow-up at Gestational Age 36 weeks and 0 days

    Female Sexual Function Index-6 (FSFI-6) score between 2 to 30

  14. Sexual dysfunction incidence at 6 weeks postpartum

    Time frame: At the follow-up at 6 weeks postpartum

    Female Sexual Function Index-6 (FSFI-6) score between 2 to 30

  15. Sexual dysfunction incidence at 3 month postpartum

    Time frame: At the follow-up at 3 month postpartum

    Female Sexual Function Index-6 (FSFI-6) score between 2 to 30

  16. Sexual dysfunction incidence at 6month postpartum

    Time frame: At the follow-up at 6 month postpartum

    Female Sexual Function Index-6 (FSFI-6) score between 2 to 30

  17. Pelvic organ prolapse (POP) 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 and 6 days)

    Pelvic Organ Prolapse Distress Inventory 6 (POPDI-6), a part of Pelvic Floor Disability Index (PFDI-20) questionnaire: score calculated by the mean value of all item scores (possible 0-4) multiplied by 25 to obtain the score (range 0 to 100).

  18. Pelvic organ prolapse (POP) incidence, in the 2nd trimester of pregnancy

    Time frame: At the follow-up at gestational age 26 weeks and 0 days

    Pelvic Organ Prolapse Distress Inventory 6 (POPDI-6), a part of Pelvic Floor Disability Index (PFDI-20) questionnaire: score calculated by the mean value of all item scores (possible 0-4) multiplied by 25 to obtain the score (range 0 to 100).

  19. Pelvic organ prolapse (POP) incidence, in the 3rd trimester of pregnancy

    Time frame: At the follow-up at gestational age 36 weeks and 0 days

    Pelvic Organ Prolapse Distress Inventory 6 (POPDI-6), a part of Pelvic Floor Disability Index (PFDI-20) questionnaire: score calculated by the mean value of all item scores (possible 0-4) multiplied by 25 to obtain the score (range 0 to 100).

  20. Pelvic organ prolapse (POP) incidence at 6 weeks postpartum

    Time frame: At the follow-up at 6 weeks postpartum

    Pelvic Organ Prolapse Distress Inventory 6 (POPDI-6), a part of Pelvic Floor Disability Index (PFDI-20) questionnaire: score calculated by the mean value of all item scores (possible 0-4) multiplied by 25 to obtain the score (range 0 to 100).

  21. Pelvic organ prolapse (POP) incidence at 3 months postpartum

    Time frame: At the follow-up at 3 months postpartum

    Pelvic Organ Prolapse Distress Inventory 6 (POPDI-6), a part of Pelvic Floor Disability Index (PFDI-20) questionnaire: score calculated by the mean value of all item scores (possible 0-4) multiplied by 25 to obtain the score (range 0 to 100).

  22. Pelvic organ prolapse (POP) incidence at 6 months postpartum

    Time frame: At the follow-up at 6 months postpartum

    Pelvic Organ Prolapse Distress Inventory 6 (POPDI-6), a part of Pelvic Floor Disability Index (PFDI-20) questionnaire: score calculated by the mean value of all item scores (possible 0-4) multiplied by 25 to obtain the score (range 0 to 100).

  23. Length of the second stage of delivery

    Time frame: The outcome is registered in electronic patient journal during delivery, but the outcome will be collected during the first 3 months postpartum.

    Length in minutes (minimum 0 - maximum 300 minutes).

  24. Delivery mode

    Time frame: The outcome is registered in electronic patient journal during delivery, but the outcome will be collected during the first 3 months postpartum.

    Vaginal, planned or unplanned Caesarean.

  25. Foetal position

    Time frame: The outcome is registered in electronic patient journal during delivery, but the outcome will be collected during the first 3 months postpartum.

    Cephalic regular (occiput anterior), cephalic occiput posterior or breech

  26. Episiotomy

    Time frame: The outcome is registered in electronic patient journal during delivery, but the outcome will be collected during the first 3 months postpartum

    Yes or no

  27. Perineal tear

    Time frame: The outcome is registered in electronic patient journal during delivery, but the outcome will be collected during the first 3 months postpartum.

    Yes or no; if yes - tear degree (1st, 2nd, 3rd (3a, 3b, 3c), 4th)

  28. Instrumental delivery

    Time frame: The outcome is registered in electronic patient journal during delivery, but the outcome will be collected during the first 3 months postpartum.

    Yes or no; if yes - type (vacuum assisted or forceps)

  29. Length of the first stage of delivery

    Time frame: The outcome is registered in electronic patient journal during delivery, but the outcome will be collected during the first 3 months postpartum.

    Length in minutes (minimum 0 - no maximum)

  30. Fidelity of PFMT

    Time frame: The questionnaire is filled every week from baseline to 6 months postpartum

    Self-reported training frequency (from 0 to 4 times a week)

  31. Other implementation outcomes: acceptability, feasibility, appropriateness

    Time frame: At study completion

    Will be collected through short interviews

Study contacts

Contact information is provided by the study sponsor or research team.

Christina Prinds

CONTACT

[email protected]

+4565504953

Greta Puriene

CONTACT

[email protected]

+4571638335

Sponsors and collaborators

Lead sponsor

University of Southern Denmark

Other

Registry information

Official study 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

Important dates

Study start
2025
Primary completion
2027
Study completion
2028
First posted
Aug 5, 2025
Registry last updated
Nov 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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