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The project seeks to investigate effectiveness of PFMT during pregnancy.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pelvic Floor Muscle Training (PFMT) | Experimental | A Danish professional pelvic floor physiotherapist together with a midwife and an urogynecologist have created a free of charge training program, which is easily accessible via a danish website "www.kvindekrop.dk" or via the app "Pelvic FloorTrainer". 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. |
|
| Standard care | Placebo Comparator | The control group will receive routine care - recommendation to do the training without any further instructions. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Urinary incontinence (UI) incidence at 3 months postpartum | International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-UI SF) score between 0 (perfect continence) and 21 (total incontinence). | At 3 months follow-up after giving birth |
| Measure | Description | Time Frame |
|---|---|---|
| Urinary incontinence at the 1st trimester of pregnancy | ICIQ-UI SF score between 0-21 | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Greta Puriene | Contact | +4571638335 | greta.puriene@rsyd.dk | |
| Christina Prinds | Contact | +4565504953 | cprinds@health.sdu.dk |
| Name | Affiliation | Role |
|---|---|---|
| Jan Stener Jørgensen | Esbjerg Hospital - University Hospital of Southern Denmark | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sygehus Sønderjylland | Recruiting | Aabenraa | Southern Denmark | 6200 | Denmark |
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| ID | Term |
|---|---|
| D014549 | Urinary Incontinence |
| D004688 | Encopresis |
| D056887 | Pelvic Organ Prolapse |
| D012735 | Sexual Dysfunction, Physiological |
| ID | Term |
|---|---|
| D014555 | Urination Disorders |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| ID | Term |
|---|---|
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
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|
| Standard care | Behavioral | Standard care |
|
ICIQ-UI SF score between 0-21
| At the follow-up at Gestational age 26 weeks and 0 days |
| Urinary incontinence incidence at the 3rd trimester of pregnancy | ICIQ-UI SF score between 0-21 | At the follow-up at Gestational Age 36 weeks and 0 days |
| Urinary incontinence incidence at 6 weeks postpartum | ICIQ-UI SF score between 0-21 | At the follow-up at 6 weeks postpartum |
| Anal incontinence (AI) incidence at inclusion, during the 1st trimester of pregnancy | 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. | 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 | 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. | At the follow-up at Gestational Age 26 weeks and 0 days |
| Anal incontinence (AI) incidence in the 3rd trimester of pregnancy | 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. | At the follow-up at Gestational Age 36 weeks and 0 days |
| Anal incontinence (AI) incidence 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. | At the follow-up at 6 weeks postpartum |
| Anal incontinence (AI) incidence 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. | At the follow-up at 3 months postpartum |
| Anal incontinence (AI) incidence 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. | At the follow-up at 6 months postpartum |
| Sexual dysfunction incidence at inclusion, during the 1st trimester of pregnancy | Female Sexual Function Index-6 (FSFI-6) score between 2 to 30 | 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 | Female Sexual Function Index-6 (FSFI-6) score between 2 to 30 | At the follow-up at Gestational Age 26weeks and 0 days |
| Sexual dysfunction incidence at inclusion, during the 3rd trimester of pregnancy | Female Sexual Function Index-6 (FSFI-6) score between 2 to 30 | At the follow-up at Gestational Age 36 weeks and 0 days |
| Sexual dysfunction incidence at 6 weeks postpartum | Female Sexual Function Index-6 (FSFI-6) score between 2 to 30 | At the follow-up at 6 weeks postpartum |
| Sexual dysfunction incidence at 3 month postpartum | Female Sexual Function Index-6 (FSFI-6) score between 2 to 30 | At the follow-up at 3 month postpartum |
| Sexual dysfunction incidence at 6month postpartum | Female Sexual Function Index-6 (FSFI-6) score between 2 to 30 | At the follow-up at 6 month postpartum |
| Pelvic organ prolapse (POP) incidence at inclusion, during the 1st 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). | At baseline, during the 1st trimester of pregnancy (gestational age (GA) up to 12 weeks and 6 days) |
| Pelvic organ prolapse (POP) incidence, 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). | At the follow-up at gestational age 26 weeks and 0 days |
| Pelvic organ prolapse (POP) incidence, 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). | At the follow-up at gestational age 36 weeks and 0 days |
| Pelvic organ prolapse (POP) incidence 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). | At the follow-up at 6 weeks postpartum |
| Pelvic organ prolapse (POP) incidence 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). | At the follow-up at 3 months postpartum |
| Pelvic organ prolapse (POP) incidence 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). | At the follow-up at 6 months postpartum |
| Length of the second stage of delivery | Length in minutes (minimum 0 - maximum 300 minutes). | The outcome is registered in electronic patient journal during delivery, but the outcome will be collected during the first 3 months postpartum. |
| Delivery mode | Vaginal, planned or unplanned Caesarean. | The outcome is registered in electronic patient journal during delivery, but the outcome will be collected during the first 3 months postpartum. |
| Foetal position | Cephalic regular (occiput anterior), cephalic occiput posterior or breech | The outcome is registered in electronic patient journal during delivery, but the outcome will be collected during the first 3 months postpartum. |
| Episiotomy | Yes or no | The outcome is registered in electronic patient journal during delivery, but the outcome will be collected during the first 3 months postpartum |
| Perineal tear | Yes or no; if yes - tear degree (1st, 2nd, 3rd (3a, 3b, 3c), 4th) | The outcome is registered in electronic patient journal during delivery, but the outcome will be collected during the first 3 months postpartum. |
| Instrumental delivery | Yes or no; if yes - type (vacuum assisted or forceps) | The outcome is registered in electronic patient journal during delivery, but the outcome will be collected during the first 3 months postpartum. |
| Length of the first stage of delivery | Length in minutes (minimum 0 - no maximum) | The outcome is registered in electronic patient journal during delivery, but the outcome will be collected during the first 3 months postpartum. |
| Fidelity of PFMT | Self-reported training frequency (from 0 to 4 times a week) | The questionnaire is filled every week from baseline to 6 months postpartum |
| Other implementation outcomes: acceptability, feasibility, appropriateness | Will be collected through short interviews | At study completion |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D059411 | Lower Urinary Tract Symptoms |
| D020924 | Urological Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012817 | Signs and Symptoms, Digestive |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D019960 | Elimination Disorders |
| D001523 | Mental Disorders |
| D011391 | Prolapse |
| D020763 | Pathological Conditions, Anatomical |
| D000091662 | Genital Diseases |