Pelvic Floor Muscle Training During Pregnancy

Not Applicable

Not yet recruiting

• Conditions: Pelvic Floor; Urinary Incontinence; Anal Incontinence; Pelvic Organ Prolapse; Sexual Dysfunction

• Registration Number: NCT07104292
• Lead Sponsor: University of Southern Denmark

Brief Summary

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.

Study Timeline

• Status Verified: 2025-07
• Study First Submitted: 2025-07-10
• Study First Submitted QC: 2025-07-28
• Last Update Submitted: 2025-07-28
• Study Start: 2025-08-01
• Study First Posted: 2025-08-05
• Last Update Posted: 2025-08-05
• Primary Completion: 2027-08-01
• Study Completion: 2028-08-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 734

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Urinary incontinence (UI) incidence at 3 months postpartum	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 Outcome Measures

Name	Time	Method
Urinary incontinence at the 1st trimester of pregnancy	At baseline, during the 1st trimester of pregnancy (gestational age (GA) up to 12 weeks +6 days)	ICIQ-UI SF score between 0-21
Urinary incontinence at the 2nd trimester of pregnancy	At the follow-up at Gestational age 26 weeks and 0 days	ICIQ-UI SF score between 0-21
Urinary incontinence incidence at the 3rd trimester of pregnancy	At the follow-up at Gestational Age 36 weeks and 0 days	ICIQ-UI SF score between 0-21
Urinary incontinence incidence at 6 weeks postpartum	At the follow-up at 6 weeks postpartum	ICIQ-UI SF score between 0-21
Anal incontinence (AI) incidence at inclusion, during the 1st trimester of pregnancy	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.
Anal incontinence (AI) in the 2nd trimester of pregnancy	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.
Anal incontinence (AI) incidence in the 3rd trimester of pregnancy	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.
Anal incontinence (AI) incidence at 6 weeks postpartum	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.
Anal incontinence (AI) incidence at 3 months postpartum	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.
Anal incontinence (AI) incidence at 6 months postpartum	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.
Sexual dysfunction incidence at inclusion, during the 1st trimester of pregnancy	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
Sexual dysfunction incidence at inclusion, during the 2nd trimester of pregnancy	At the follow-up at Gestational Age 26weeks and 0 days	Female Sexual Function Index-6 (FSFI-6) score between 2 to 30
Sexual dysfunction incidence at inclusion, during the 3rd trimester of pregnancy	At the follow-up at Gestational Age 36 weeks and 0 days	Female Sexual Function Index-6 (FSFI-6) score between 2 to 30
Sexual dysfunction incidence at 6 weeks postpartum	At the follow-up at 6 weeks postpartum	Female Sexual Function Index-6 (FSFI-6) score between 2 to 30
Sexual dysfunction incidence at 3 month postpartum	At the follow-up at 3 month postpartum	Female Sexual Function Index-6 (FSFI-6) score between 2 to 30
Sexual dysfunction incidence at 6month postpartum	At the follow-up at 6 month postpartum	Female Sexual Function Index-6 (FSFI-6) score between 2 to 30
Pelvic organ prolapse (POP) incidence at inclusion, during the 1st trimester of pregnancy	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).
Pelvic organ prolapse (POP) incidence, in the 2nd trimester of pregnancy	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).
Pelvic organ prolapse (POP) incidence, in the 3rd trimester of pregnancy	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).
Pelvic organ prolapse (POP) incidence at 6 weeks postpartum	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).
Pelvic organ prolapse (POP) incidence at 3 months postpartum	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).
Pelvic organ prolapse (POP) incidence at 6 months postpartum	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).
Length of the second stage of delivery	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).
Delivery mode	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.
Foetal position	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
Episiotomy	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
Perineal tear	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)
Instrumental delivery	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)
Length of the first stage of delivery	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)
Fidelity of PFMT	The questionnaire is filled every week from baseline to 6 months postpartum	Self-reported training frequency (from 0 to 4 times a week)
Other implementation outcomes: acceptability, feasibility, appropriateness	At study completion	Will be collected through short interviews

Trial Locations

Locations (1)

Sygehus Sønderjylland; 🇩🇰 Aabenraa, Southern Denmark, Denmark