NCT07104292招募中不适用
PFMT During Pregnancy - Its Implementation and Effects on Pelvic Floor Disorders, Sexual Function and Obstetric Outcomes: a Hybrid Type 1 Design Randomised Controlled Trial
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 734
- 试验地点
- 1
- 主要终点
- Urinary incontinence (UI) incidence at 3 months postpartum
研究概览
简要总结
The project seeks to investigate effectiveness of PFMT during pregnancy.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
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.
干预措施: PFMT (Behavioral)
Standard care
Placebo Comparator
The control group will receive routine care - recommendation to do the training without any further instructions.
干预措施: Standard care (Behavioral)
结局指标
主要结局
Urinary incontinence (UI) incidence at 3 months postpartum
时间窗: 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).
Urinary incontinence (UI) incidence at 3 months postpartum
时间窗: 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).
次要结局
- 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))
- Urinary incontinence at the 2nd trimester of pregnancy(At the follow-up at Gestational age 26 weeks and 0 days)
- Urinary incontinence incidence at the 3rd trimester of pregnancy(At the follow-up at Gestational Age 36 weeks and 0 days)
- Urinary incontinence incidence at 6 weeks postpartum(At the follow-up at 6 weeks postpartum)
- Sexual dysfunction incidence at inclusion, during the 3rd trimester of pregnancy(At the follow-up at Gestational Age 36 weeks and 0 days)
- 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))
- Anal incontinence (AI) in the 2nd trimester of pregnancy(At the follow-up at Gestational Age 26 weeks and 0 days)
- Anal incontinence (AI) incidence in the 3rd trimester of pregnancy(At the follow-up at Gestational Age 36 weeks and 0 days)
- Anal incontinence (AI) incidence at 6 weeks postpartum(At the follow-up at 6 weeks postpartum)
- Anal incontinence (AI) incidence at 3 months postpartum(At the follow-up at 3 months postpartum)
- Anal incontinence (AI) incidence at 6 months postpartum(At the follow-up at 6 months postpartum)
- 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))
- Sexual dysfunction incidence at inclusion, during the 2nd trimester of pregnancy(At the follow-up at Gestational Age 26weeks and 0 days)
- Sexual dysfunction incidence at 6 weeks postpartum(At the follow-up at 6 weeks postpartum)
- Sexual dysfunction incidence at 3 month postpartum(At the follow-up at 3 month postpartum)
- Sexual dysfunction incidence at 6month postpartum(At the follow-up at 6 month postpartum)
- 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 (POP) incidence, in the 2nd trimester of pregnancy(At the follow-up at gestational age 26 weeks and 0 days)
- 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 (POP) incidence at 6 weeks postpartum(At the follow-up at 6 weeks postpartum)
- Pelvic organ prolapse (POP) incidence at 6 months postpartum(At the follow-up at 6 months postpartum)
- 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.)
- Perineal tear(The outcome is registered in electronic patient journal during delivery, but the outcome will be collected during the first 3 months postpartum.)
- Instrumental delivery(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(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(The questionnaire is filled every week from baseline to 6 months postpartum)
- 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))
- Urinary incontinence at the 2nd trimester of pregnancy(At the follow-up at Gestational age 26 weeks and 0 days)
- Urinary incontinence incidence at the 3rd trimester of pregnancy(At the follow-up at Gestational Age 36 weeks and 0 days)
- Urinary incontinence incidence at 6 weeks postpartum(At the follow-up at 6 weeks postpartum)
- 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))
- Anal incontinence (AI) in the 2nd trimester of pregnancy(At the follow-up at Gestational Age 26 weeks and 0 days)
- Anal incontinence (AI) incidence in the 3rd trimester of pregnancy(At the follow-up at Gestational Age 36 weeks and 0 days)
- Anal incontinence (AI) incidence at 6 months postpartum(At the follow-up at 6 months postpartum)
- Anal incontinence (AI) incidence at 6 weeks postpartum(At the follow-up at 6 weeks postpartum)
- Anal incontinence (AI) incidence at 3 months postpartum(At the follow-up at 3 months postpartum)
- 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))
- Sexual dysfunction incidence at inclusion, during the 2nd trimester of pregnancy(At the follow-up at Gestational Age 26weeks and 0 days)
- Sexual dysfunction incidence at inclusion, during the 3rd trimester of pregnancy(At the follow-up at Gestational Age 36 weeks and 0 days)
- Sexual dysfunction incidence at 6 weeks postpartum(At the follow-up at 6 weeks postpartum)
- Sexual dysfunction incidence at 3 month postpartum(At the follow-up at 3 month postpartum)
- Sexual dysfunction incidence at 6month postpartum(At the follow-up at 6 month postpartum)
- 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 (POP) incidence, in the 2nd trimester of pregnancy(At the follow-up at gestational age 26 weeks and 0 days)
- 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 (POP) incidence at 6 weeks postpartum(At the follow-up at 6 weeks postpartum)
- Pelvic organ prolapse (POP) incidence at 3 months postpartum(At the follow-up at 3 months postpartum)
- Pelvic organ prolapse (POP) incidence at 6 months postpartum(At the follow-up at 6 months postpartum)
- 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.)
- Delivery mode(The outcome is registered in electronic patient journal during delivery, but the outcome will be collected during the first 3 months postpartum.)
- Foetal position(The outcome is registered in electronic patient journal during delivery, but the outcome will be collected during the first 3 months postpartum.)
- Episiotomy(The outcome is registered in electronic patient journal during delivery, but the outcome will be collected during the first 3 months postpartum)
- Perineal tear(The outcome is registered in electronic patient journal during delivery, but the outcome will be collected during the first 3 months postpartum.)
- Instrumental delivery(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(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(The questionnaire is filled every week from baseline to 6 months postpartum)
- Other implementation outcomes: acceptability, feasibility, appropriateness(At study completion)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
不适用
Pelvic Floor Muscle Exercise During PregnancyLower Urinary Tract SymptomsSexual FunctionNCT06279455Istanbul University - Cerrahpasa70
进行中（未招募）
不适用
Manual Physical Therapy During Pregnancy on Post Partum Perineal Trauma and PainPregnancy RelatedPelvic Floor DisordersInjury, Maternal DeliveryNCT04660708University of Wisconsin, Milwaukee105
已完成
不适用
Examination of the Effects of Pelvic Floor Muscle Exercises on Blood Flow in Pregnant WomenPelvic Floor Muscle TrainingPregnancyBlood Flow IndexesNCT06861335Celal Bayar University47
已完成
不适用
Effectiveness of Pelvic Floor Muscles Training in Group for Women With Urinary IncontinenceUrinary IncontinenceNCT03500185Hospital de Clinicas de Porto Alegre56
招募中
不适用
Assessment of Pelvic Floor Muscle Training Using Modern Conservative Methods in the Therapy of Stress Urinary IncontinenceStress Urinary IncontinenceNCT06673875Brno University Hospital90