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RecruitingNCT07104292Updated Oct 8, 2026

Pelvic Floor Muscle Training During Pregnancy

An interventional study of PFMT and Standard care in Urinary Incontinence, Anal Incontinence and Pelvic Organ Prolapse, sponsored by University of Southern Denmark. Recruiting at 1 site in Denmark. Open to female participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-08.

Sponsored by University of Southern Denmark · Not applicable, Interventional, and Prevention

From the registry’s dates

  • Started Oct 2025; still recruiting 1 year later.
Updated Oct 8, 2026Enrollment updatedEligibility revised+1 moreGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
804
Allocation
Randomized
Ages
18 Years and older
Sex
Female
01

Study summary

The project seeks to investigate effectiveness of PFMT during pregnancy.

Read the 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 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 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.

02

Conditions studied

  • Urinary Incontinence
  • Anal Incontinence
  • Pelvic Organ Prolapse
  • Sexual Dysfunction
  • Pelvic Floor Disorder

Keywords

  • Pelvic floor muscle training
  • Pregnancy
  • Nulliparous women
  • urinary incontinence
  • Pelvic floor disorders
  • sexual function
  • obstetric outcomes
  • implementation
  • Randomised controlled trial
03

In context

Urinary Incontinence

983 studies on the registry are indexed under Urinary Incontinence; 180 are open to participants now.

This study's planned enrollment of 804 is above the median of 66 across 739 interventional studies indexed under Urinary Incontinence.

Browse Urinary Incontinence studies →

Lead sponsor

University of Southern Denmark is the lead sponsor of 336 studies on the registry; 46 are open to participants now.

Browse University of Southern Denmark studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

The criteria were revised on the registry on Oct 8, 2026. See what changed

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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 (due to cognitive impairment or language barriers)
  • Previous pregnancy of > 16 weeks of gestation
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
804 participants (estimated)

Study arms

  • Experimental
    Pelvic Floor Muscle Training (PFMT)

    Participants receive access to the pelvic floor muscle training programme in addition to usual antenatal care. The programme is delivered through a mobile application and supporting materials is sent out.

    Behavioral: PFMT

  • Placebo comparator
    Standard care

    The control group will receive routine care - recommendation to do the training without any further instructions.

    Behavioral: Standard care

Interventions

  • BehavioralPFMT

    A structured home-based pelvic floor muscle training programme consisting of progressive pelvic floor muscle exercises, training reminders as well as supportive information with educational materials and habit-building strategies. Participants are advised to perform pelvic floor muscle training three to five times per week during pregnancy and continue after birth.

  • BehavioralStandard care

    Routine antenatal care provided according to local clinical practice. This may include general information about pelvic floor muscle training but does not include access to the study programme, study application, structured training support, or study-specific reminders.

06

What researchers measure

Primary outcomes

  1. The presence of urinary incontinence (UI) at 3 months postpartum

    International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-UI SF) score \> 0.

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

Secondary outcomes

  1. The presence of urinary incontinence at inclusion

    ICIQ-UI SF score between 0-21. Outcome is defined if (ICIQ-UI SF total score \> 0) (binary outcome)

    Time frame: At baseline: inclusion

  2. Urinary incontinence severity at inclusion

    ICIQ-UI SF score between 0-21. Outcome is continuous

    Time frame: At baseline: inclusion

  3. The presence of urinary incontinence at the 2nd trimester of pregnancy

    ICIQ-UI SF score between 0-21. Outcome is defined if (ICIQ-UI SF total score \> 0) (binary outcome)

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

  4. Urinary incontinence severity at the 2nd trimester of pregnancy

    ICIQ-UI SF score between 0-21. Outome is continuous

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

  5. The presence of urinary incontinence at the 3rd trimester of pregnancy

    ICIQ-UI SF score between 0-21. Outcome is defined if (ICIQ-UI SF total score \> 0) (binary outcome)

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

  6. Urinary incontinence severity at the 3rd trimester of pregnancy

    ICIQ-UI SF score between 0-21. Outcome is continuous

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

  7. The presence of urinary incontinence at 6 months postpartum

    ICIQ-UI SF score between 0-21. Outcome is defined if (ICIQ-UI SF total score \> 0) (binary

    Time frame: At follow-up at 6 months postpartum

  8. UI severity at 6 months postpartum

    IICIQ-UI SF score between 0-21. Outcome is continuous

    Time frame: At follow-up at 6 months postpartum

  9. The presence of anal incontinence (AI) at inclusion

    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). Outcome is binary and defined by positive response to any of the three questions about anal incontinence (question 9, 10 and 11)

    Time frame: At baseline: inclusion

  10. Colorectal-anal symptoms severity at inclusion

    Defined by the CRAD-8 score (Colorectal-anal distress inventory 8), continuous outcome, Higher score indicates greater symptom severity

    Time frame: At baseline: inclusion

  11. The presence of anal incontinence (AI) in the 2nd trimester of pregnancy

    Colorectal-anal distress inventory 8 (CRAD-8), score 0-100. Outcome is binary and defined by positive response to any of the three questions about anal incontinence (question 9, 10 and 11)

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

  12. Colorectal-anal symptoms severity 2nd trimester of pregnancy

    Defined by the CRAD-8 score (Colorectal-anal distress inventory 8), continuous outcome, Higher score indicates greater symptom severity

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

  13. The presence of anal incontinence (AI) in the 3rd trimester of pregnancy

    Colorectal-anal distress inventory 8 (CRAD-8), score 0-100. Outcome is binary and defined by positive response to any of the three questions about anal incontinence (question 9, 10 and 11)

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

  14. Colorectal-anal symptoms severity 3rd trimester of pregnancy

    Defined by the CRAD-8 score (Colorectal-anal distress inventory 8), continuous outcome, Higher score indicates greater symptom severity

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

  15. The presence of anal incontinence (AI) at 3 months postpartum

    Colorectal-anal distress inventory 8 (CRAD-8), score 0-100. Outcome is binary and defined by positive response to any of the three questions about anal incontinence (question 9, 10 and 11)

    Time frame: At follow-up 3 months postpartum

  16. Colorectal-anal symptoms severity 3 months postpartum

    Defined by the CRAD-8 score (Colorectal-anal distress inventory 8), continuous outcome, Higher score indicates greater symptom severity

    Time frame: At follow-up 3 months postpartum

  17. The presence of anal incontinence (AI) at 6 months postpartum

    Colorectal-anal distress inventory 8 (CRAD-8), score 0-100. Outcome is binary and defined by positive response to any of the three questions about anal incontinence (question 9, 10 and 11)

    Time frame: At follow-up 6 months postpartum

  18. Colorectal-anal symptoms severity 6 months postpartum

    Defined by the CRAD-8 score (Colorectal-anal distress inventory 8), continuous outcome, Higher score indicates greater symptom severity

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

  19. The presence of sexual dysfunction at inclusion

    Female Sexual Function Index-6 (FSFI-6) score between 2 to 30. Outcome is defined if FSFI-6 score is ≤ 19

    Time frame: At baseline: inclusion

  20. Sexual dysfunction severity at inclusion

    Female Sexual Function Index-6 (FSFI-6) score between 2 to 30. Outcome is continuous

    Time frame: At baseline: inclusion

  21. The presence of sexual dysfunction at inclusion, during the 2nd trimester of pregnancy

    Female Sexual Function Index-6 (FSFI-6) score between 2 to 30. Outcome is defined if FSFI-6 score is ≤ 19

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

  22. Sexual dysfunction severity at inclusion, during the 2nd trimester of pregnancy

    Female Sexual Function Index-6 (FSFI-6) score between 2 to 30. Outcome is continuous. Lower scores indicate poorer sexual functioning

    Time frame: At follow-up gestational Age 26 weeks and 0 days

  23. The presence of sexual dysfunction at inclusion, during the 3rd trimester of pregnancy

    Female Sexual Function Index-6 (FSFI-6) score between 2 to 30. Outcome is defined if FSFI-6 score is ≤ 19

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

  24. Sexual dysfunction severity at inclusion, during the 3rd trimester of pregnancy

    Female Sexual Function Index-6 (FSFI-6) score between 2 to 30. Outcome is continuous. Lower scores indicate poorer sexual functioning

    Time frame: At follow-up gestational Age 36 weeks and 0 days

  25. The presence of sexual dysfunction at 3 month postpartum

    Female Sexual Function Index-6 (FSFI-6) score between 2 to 30. Outcome is defined if FSFI-6 score is ≤ 19. Lower scores indicate poorer sexual functioning

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

  26. Sexual dysfunction severity at 3 month postpartum

    Female Sexual Function Index-6 (FSFI-6) score between 2 to 30. Outcome is continuous. Lower scores indicate poorer sexual functioning

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

  27. The presence of sexual dysfunction at 6month postpartum

    Female Sexual Function Index-6 (FSFI-6) score between 2 to 30. Outcome is defined if FSFI-6 score is ≤ 19. Lower scores indicate poorer sexual functioning

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

  28. Sexual dysfunction severity at 6months postpartum

    Female Sexual Function Index-6 (FSFI-6) score between 2 to 30. Outcome is continuous. Lower scores indicate poorer sexual functioning

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

  29. The presence of pelvic organ prolapse (POP) symptoms at inclusion

    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). Outcome defined if POPDI-6 score \> 0

    Time frame: At baseline: inclusion

  30. Pelvic organ prolapse (POP) symptoms severity at inclusion

    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). Outcome is continuous

    Time frame: At baseline: inclusion

  31. The presence of pelvic organ prolapse (POP) symptoms, in the 2nd trimester of pregnancy

    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). Outcome defined if POPDI-6 score \> 0

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

  32. Pelvic organ prolapse (POP) symptoms severity, in the 2nd trimester of pregnancy

    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). Outcome is continuous

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

  33. The presence of pelvic organ prolapse (POP) symptoms, in the 3rd trimester of pregnancy

    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). Outcome defined if POPDI-6 score \> 0

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

  34. Pelvic organ prolapse (POP) symptoms severity, in the 3rd trimester of pregnancy

    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). Outcome is continuous

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

  35. The presence of pelvic organ prolapse (POP) symptoms 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). Outcome defined if POPDI-6 score \> 0

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

  36. Pelvic organ prolapse (POP) symptoms severity 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). Outcome is continuous

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

  37. The presence of pelvic organ prolapse (POP) symptoms 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). Outcome defined if POPDI-6 score \> 0

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

  38. Pelvic organ prolapse (POP) symptoms severity 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). Outcome is continuous

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

  39. Delivery mode

    Outcome is defined as categorical: vaginal, planned cesarean, emergency cesarean

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

  40. Foetal position

    Cephalic regular (occiput anterior), cephalic occiput posterior or breech. Outcome is categorical

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

  41. Episiotomy

    Yes or no. Outcome is binary

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

  42. Perineal tear

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

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

  43. Instrumental delivery

    Yes or no; if yes - type (vacuum assisted or forceps). Outcome is binary

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

  44. Fidelity of PFMT

    Self-reported training frequency (0 times, 1-2 times, 3-4 times or more per week)

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

  45. Implementation outcomes

    Collected through short interviews

    Time frame: At study completion

  46. Proportion of participants reporting capability-, opportunity-, and motivation-related barriers and facilitators for pelvic floor muscle training.

    Capability, Opportunity and Motivation (COM-B) related to pelvic floor muscle training, assessed using a study-specific COM-B Self-Evaluation Questionnaire. Participants may select one or more response options within the domains of capability, opportunity, and motivation. Participants may select one or more response options within the domains of capability, opportunity, and motivation. Responses are analysed as individual items (selected/not selected), and no total score is calculated. Therefore, minimum and maximum values are not applicable. A higher frequency of endorsement of a specific item indicates a greater perceived barrier, need, or facilitator related to pelvic floor muscle training.

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

  47. Length of the first stage of delivery

    Length in minutes (minimum 0 - no maximum)

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

  48. Length of the passive second stage of delivery

    Outcome is continuous and Length in minutes (minimum 0 - maximum 300 minutes).

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

  49. Length of the active second stage of delivery

    Outcome is continuous and Length in minutes (minimum 0 - maximum 300 minutes).

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

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

1 registry update since Sep 25, 2026
Enrollment
734→804
Oct 8, 2026
Eligibility
1 inclusion criterion edited
What changed in the criteria
Inclusion criteria
  • ChangedBefore Woman in the 1st trimester of pregnancy (up to 12+6 weeks of gestation)Now up to 12+6 weeks of gestation to receive invitation and up to 16+0 weeks of gestation to be enrolled
Oct 8, 2026
Primary outcomes
1 edited
What changed in the outcomes
  • EditedUrinaryThe presence of urinary incontinence (UI) incidence at 3 months postpartumTime frame: At 3 months follow-up after giving birth
Oct 8, 2026
Secondary outcomes
23 edited, 7 added, 19 more
What changed in the outcomes
  • EditedUrinaryThe presence of urinary incontinence at the 1st2nd trimester of pregnancyTime frame: At baseline, during the 1st trimester of pregnancy (gestational age (GA) up to 12 weeks +6 days) → At follow-up gestational age 26 weeks and 0 days
  • EditedUrinary incontinence severity at the 2nd trimester of pregnancyTime frame: At the follow-up at Gestational age 26 weeks and 0 days → At follow-up gestational age 26 weeks and 0 days
  • EditedUrinaryThe presence of urinary incontinence incidence at the 3rd trimester of pregnancyTime frame: At the follow-up at Gestational Age 36 weeks and 0 days → At follow-up gestational age 36 weeks and 0 days
  • EditedUrinary incontinence incidenceseverity at 6 weeks postpartuminclusionTime frame: At the follow-up at 6 weeks postpartum → At baseline: inclusion
  • EditedAnalUrinary incontinence (AI) incidenceseverity at inclusion, during the 1st3rd trimester of pregnancyTime frame: At baseline, during the 1st trimester of pregnancy (gestational age (GA) up to 12 weeks +6 days) → At follow-up gestational age 36 weeks and 0 days
  • EditedAnalThe presence of anal incontinence (AI) in the 2nd trimester of pregnancyTime frame: At the follow-up at Gestational Age 26 weeks and 0 days → At follow-up gestational age 26 weeks and 0 days
  • EditedAnalThe presence of anal incontinence (AI) incidence in the 3rd trimester of pregnancyTime frame: At the follow-up at Gestational Age 36 weeks and 0 days → At follow-up gestational age 36 weeks and 0 days
  • EditedAnalThe presence of anal incontinence (AI) incidence at 6 weeks postpartuminclusionTime frame: At the follow-up at 6 weeks postpartum → At baseline: inclusion
  • EditedAnalThe presence of anal incontinence (AI) incidence at 3 months postpartumTime frame: At the follow-up at 3 months postpartum → At follow-up 3 months postpartum
  • EditedAnalThe presence of urinary incontinence (AI) incidence at 6 months postpartumTime frame: At the follow-up at 6 months postpartum → At follow-up at 6 months postpartum
  • EditedSexualThe presence of sexual dysfunction incidence at inclusion, during the 1st2nd trimester of pregnancyTime frame: At baseline, during the 1st trimester of pregnancy (gestational age (GA) up to 12 weeks +6 days) → At follow-up at gestational age 26 weeks and 0 days
  • EditedSexual dysfunction incidenceseverity at inclusion, during the 2nd trimester of pregnancyTime frame: At the follow-up at Gestational Age 26weeks and 0 days → At follow-up gestational Age 26 weeks and 0 days
  • EditedSexualThe presence of sexual dysfunction incidence at inclusion, during the 3rd trimester of pregnancyTime frame: At the follow-up at Gestational Age 36 weeks and 0 days → At follow-up at gestational Age 36 weeks and 0 days
  • EditedSexual dysfunction incidenceseverity at 6 weeks postpartuminclusionTime frame: At the follow-up at 6 weeks postpartum → At baseline: inclusion
  • EditedSexualThe presence of sexual dysfunction incidence at 3 month postpartumTime frame: At the follow-up at 3 month postpartum
  • EditedSexual dysfunction incidenceseverity at 6month3 month postpartumTime frame: At the follow-up at 6 month postpartum → At the follow-up at 3 month postpartum
  • EditedPelvic organ prolapse (POP) incidenceSexual dysfunction severity at inclusion, during the 1st3rd trimester of pregnancyTime frame: At baseline, during the 1st trimester of pregnancy (gestational age (GA) up to 12 weeks and 6 days) → At follow-up gestational Age 36 weeks and 0 days
  • EditedPelvic organ prolapse (POP) incidence, in the 2nd trimester of pregnancysymptoms severity at inclusionTime frame: At the follow-up at gestational age 26 weeks and 0 days → At baseline: inclusion
  • EditedPelvicThe presence of pelvic organ prolapse (POP) incidencesymptoms, in the 3rd2nd trimester of pregnancyTime frame: At the follow-up at gestational age 36 weeks and 0 days → At follow-up gestational age 26 weeks and 0 days
  • EditedPelvicThe presence of pelvic organ prolapse (POP) incidencesymptoms at 6 weeks postpartuminclusionTime frame: At the follow-up at 6 weeks postpartum → At baseline: inclusion
  • EditedPelvicThe presence of pelvic organ prolapse (POP) incidencesymptoms at 3 months postpartumTime frame: At the follow-up at 3 months postpartum
  • EditedPelvic organ prolapseThe presence of anal incontinence (POPAI) incidence at 6 months postpartumTime frame: At the follow-up at 6 months postpartum → At follow-up 6 months postpartum
  • EditedLength of the passive second stage of deliveryTime frame: The outcome is registered in electronic patient journal during delivery, but the outcome will be collected during the first 3 months postpartum.
  • AddedThe presence of urinary incontinence at inclusionTime frame: At baseline: inclusion
  • AddedUI severity at 6 months postpartumTime frame: At follow-up at 6 months postpartum
  • AddedColorectal-anal symptoms severity at inclusionTime frame: At baseline: inclusion
  • AddedColorectal-anal symptoms severity 2nd trimester of pregnancyTime frame: At follow-up gestational age 26 weeks and 0 days
  • AddedColorectal-anal symptoms severity 3rd trimester of pregnancyTime frame: At follow-up at gestational age 36 weeks and 0 days
  • AddedColorectal-anal symptoms severity 3 months postpartumTime frame: At follow-up 3 months postpartum
  • AddedColorectal-anal symptoms severity 6 months postpartumTime frame: At the follow-up at 6 months postpartum
  • …and 19 more, on the record history on ClinicalTrials.gov ↗
Oct 8, 2026
Show all 1 update
  1. Oct 8, 2026
    Enrollment 734→804
    Eligibility 1 inclusion criterion edited
    What changed in the criteria
    Inclusion criteria
    • ChangedBefore Woman in the 1st trimester of pregnancy (up to 12+6 weeks of gestation)Now up to 12+6 weeks of gestation to receive invitation and up to 16+0 weeks of gestation to be enrolled
    Primary outcomes 1 edited
    What changed in the outcomes
    • EditedUrinaryThe presence of urinary incontinence (UI) incidence at 3 months postpartumTime frame: At 3 months follow-up after giving birth
    Secondary outcomes 23 edited, 7 added, 19 more
    What changed in the outcomes
    • EditedUrinaryThe presence of urinary incontinence at the 1st2nd trimester of pregnancyTime frame: At baseline, during the 1st trimester of pregnancy (gestational age (GA) up to 12 weeks +6 days) → At follow-up gestational age 26 weeks and 0 days
    • EditedUrinary incontinence severity at the 2nd trimester of pregnancyTime frame: At the follow-up at Gestational age 26 weeks and 0 days → At follow-up gestational age 26 weeks and 0 days
    • EditedUrinaryThe presence of urinary incontinence incidence at the 3rd trimester of pregnancyTime frame: At the follow-up at Gestational Age 36 weeks and 0 days → At follow-up gestational age 36 weeks and 0 days
    • EditedUrinary incontinence incidenceseverity at 6 weeks postpartuminclusionTime frame: At the follow-up at 6 weeks postpartum → At baseline: inclusion
    • EditedAnalUrinary incontinence (AI) incidenceseverity at inclusion, during the 1st3rd trimester of pregnancyTime frame: At baseline, during the 1st trimester of pregnancy (gestational age (GA) up to 12 weeks +6 days) → At follow-up gestational age 36 weeks and 0 days
    • EditedAnalThe presence of anal incontinence (AI) in the 2nd trimester of pregnancyTime frame: At the follow-up at Gestational Age 26 weeks and 0 days → At follow-up gestational age 26 weeks and 0 days
    • EditedAnalThe presence of anal incontinence (AI) incidence in the 3rd trimester of pregnancyTime frame: At the follow-up at Gestational Age 36 weeks and 0 days → At follow-up gestational age 36 weeks and 0 days
    • EditedAnalThe presence of anal incontinence (AI) incidence at 6 weeks postpartuminclusionTime frame: At the follow-up at 6 weeks postpartum → At baseline: inclusion
    • EditedAnalThe presence of anal incontinence (AI) incidence at 3 months postpartumTime frame: At the follow-up at 3 months postpartum → At follow-up 3 months postpartum
    • EditedAnalThe presence of urinary incontinence (AI) incidence at 6 months postpartumTime frame: At the follow-up at 6 months postpartum → At follow-up at 6 months postpartum
    • EditedSexualThe presence of sexual dysfunction incidence at inclusion, during the 1st2nd trimester of pregnancyTime frame: At baseline, during the 1st trimester of pregnancy (gestational age (GA) up to 12 weeks +6 days) → At follow-up at gestational age 26 weeks and 0 days
    • EditedSexual dysfunction incidenceseverity at inclusion, during the 2nd trimester of pregnancyTime frame: At the follow-up at Gestational Age 26weeks and 0 days → At follow-up gestational Age 26 weeks and 0 days
    • EditedSexualThe presence of sexual dysfunction incidence at inclusion, during the 3rd trimester of pregnancyTime frame: At the follow-up at Gestational Age 36 weeks and 0 days → At follow-up at gestational Age 36 weeks and 0 days
    • EditedSexual dysfunction incidenceseverity at 6 weeks postpartuminclusionTime frame: At the follow-up at 6 weeks postpartum → At baseline: inclusion
    • EditedSexualThe presence of sexual dysfunction incidence at 3 month postpartumTime frame: At the follow-up at 3 month postpartum
    • EditedSexual dysfunction incidenceseverity at 6month3 month postpartumTime frame: At the follow-up at 6 month postpartum → At the follow-up at 3 month postpartum
    • EditedPelvic organ prolapse (POP) incidenceSexual dysfunction severity at inclusion, during the 1st3rd trimester of pregnancyTime frame: At baseline, during the 1st trimester of pregnancy (gestational age (GA) up to 12 weeks and 6 days) → At follow-up gestational Age 36 weeks and 0 days
    • EditedPelvic organ prolapse (POP) incidence, in the 2nd trimester of pregnancysymptoms severity at inclusionTime frame: At the follow-up at gestational age 26 weeks and 0 days → At baseline: inclusion
    • EditedPelvicThe presence of pelvic organ prolapse (POP) incidencesymptoms, in the 3rd2nd trimester of pregnancyTime frame: At the follow-up at gestational age 36 weeks and 0 days → At follow-up gestational age 26 weeks and 0 days
    • EditedPelvicThe presence of pelvic organ prolapse (POP) incidencesymptoms at 6 weeks postpartuminclusionTime frame: At the follow-up at 6 weeks postpartum → At baseline: inclusion
    • EditedPelvicThe presence of pelvic organ prolapse (POP) incidencesymptoms at 3 months postpartumTime frame: At the follow-up at 3 months postpartum
    • EditedPelvic organ prolapseThe presence of anal incontinence (POPAI) incidence at 6 months postpartumTime frame: At the follow-up at 6 months postpartum → At follow-up 6 months postpartum
    • EditedLength of the passive second stage of deliveryTime frame: The outcome is registered in electronic patient journal during delivery, but the outcome will be collected during the first 3 months postpartum.
    • AddedThe presence of urinary incontinence at inclusionTime frame: At baseline: inclusion
    • AddedUI severity at 6 months postpartumTime frame: At follow-up at 6 months postpartum
    • AddedColorectal-anal symptoms severity at inclusionTime frame: At baseline: inclusion
    • AddedColorectal-anal symptoms severity 2nd trimester of pregnancyTime frame: At follow-up gestational age 26 weeks and 0 days
    • AddedColorectal-anal symptoms severity 3rd trimester of pregnancyTime frame: At follow-up at gestational age 36 weeks and 0 days
    • AddedColorectal-anal symptoms severity 3 months postpartumTime frame: At follow-up 3 months postpartum
    • AddedColorectal-anal symptoms severity 6 months postpartumTime frame: At the follow-up at 6 months postpartum
    • …and 19 more, on the record history on ClinicalTrials.gov ↗
    + 7 other changes: index terms, identifiers, responsible party, description, conditions, arm descriptions and contact details

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07104292
Lead sponsor
University of Southern Denmark
Collaborators
Kolding Sygehus, Esbjerg Hospital - University Hospital of Southern Denmark, Odense University Hospital, Hospital Sønderjylland
Responsible party
Sponsor
First posted
Aug 5, 2025
Start date
Oct 27, 2025
Primary completion
Aug 1, 2027 (estimated)
Completion
Aug 1, 2028 (estimated)
Last update
Oct 8, 2026

Study contacts

Greta Puriene
Contact
greta.puriene@rsyd.dk
+4571638335
Christina Prinds
Contact
cprinds@health.sdu.dk
+4565504953
Greta Puriene
principal investigator · Hospital Sønderjylland

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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