The Effect of a Postpartum Training Program on Women Who Have Suffered a Levator Ani Injury. A Pilot Randomized Controlled Trial Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 78
- 试验地点
- 1
- 主要终点
- Morphometry with ultrasound Area
研究概览
简要总结
The goal of this pilot randomized pilot controlled trial (RTC)is to collect acceptability and feasibility outcomes of a physiotherapy individualized program in women with levator injury that is intended to be used in a larger scale multicenter randomized controlled trial (RTC) in the future. The main questions it aims to answer are if a physiotherapy program in women with a levator injury:
- Can improve the pelvic floor morphometry (PFM).
- Can improve urogynecological symptoms
- The effect of a physiotherapy program in the sexual function
- The effect of a physiotherapy program in the patient's fear avoidance beliefs about physical activity and work Type of study: randomized pilot controlled trial (RTC) The design of this trial will be a pilot randomized controlled trial with 3 arms. Participants will be randomized in 2 arm of women with levator ani injury to either physiotherapy or standard care and an arm of woman without levator injury Researchers will compare the 3 groups to see if a physiotherapy program have benefits in morphometry of the pelvic floor, urogynecological symptoms, sexual function and to avoid fear avoidance beliefs about physical activity and work.
详细描述
The levator ani is a broad, thin muscle group, situated on either side of the pelvis. It supports the viscera in the pelvic cavity, and surrounds the various structures that pass through it. The levator ani muscles are of central importance in pelvic organ support and the maintenance of urinary and fecal continence. Vaginal delivery was associated with a higher number of pelvic floors injury at different levels (10% to 30% of women with vaginal deliveries). One of these specific types of pelvic floor injury include levator avulsion muscle (LAM) and levator ballooning. International clinical guidelines in agreement with meta-analysis recommend pelvic floor muscle (PFM) physiotherapy as a first line treatment for symptoms related to postpartum injuries. However, it is unclear whether women with levator ani injury lesions could respond to physiotherapy. There have been no randomized studies on this matter and the pilot studies have focused on anatomy rather than symptoms.
Trial Design A randomized pilot-controlled trial is designed to collect acceptability and feasibility outcomes of a physiotherapy individualized program in women with levator ani injury that is intended to be used in a larger scale multicenter randomized controlled trial in the future.
Methods The design of this trial will be a pilot randomized controlled trial with 3 arms:2 randomized arm of women with levator ani injury to either physiotherapy or standard care and an arm of woman without levator injury Participants Assessed for eligibility will be primiparous with a simplex vaginal delivery, aged ≥18 years, that understands the Swedish language, who approve vaginal examinations and with known risk factors for avulsion (instrumental delivery, maternal age >35 years, prolonged or precipitous second stage, and fetal occipito-posterior position).
10-12 weeks after the delivery a clinical 3 D ultrasound of pelvic floor will be perform.
Women with an injury in the levator ani will be randomized into two groups, one for intervention and the other for control.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •simplex vaginal first delivery with a elevator ani injury
- •aged ≥18 years
- •understands the Swedish language in speech and writing
- •approves vaginal examination
排除标准
- •diagnosed sphincter injury grade 3-4
- •serious postpartum disease (heart failure, thrombophlebitis, recent pulmonary embolism, acute infectious disease, genital haemorrhage, severe hypertension, dyspnoea, severe anemia or severe mental illness)
结局指标
主要结局
Morphometry with ultrasound Area
时间窗: 12 months after delivery
3-D Ultrasound examination., Levator hiatus area at rest (cm2),during Valsalva (cm2) and at maximum contraction (cm2)
Feasibility of the trial.
时间窗: 12 months after delivery
The number of those referred to the trial over the study period, who meet the eligibility criteria, the number of eligible patients who consent to participate in the trial over the study period, and the number of patients who decline to participate, the number of participants who consent to participate that remain in the trial by 4-month follow-up, the number/proportion of participants with complete baseline data over the study period, the number/proportion of participants with complete follow-up data at 4 months follow-up, the number/proportion of participants retained at the end of each module of treatment.
Morphometry with ultrasound Levator urethra GAP (LUG)
时间窗: 12 months after delivery
The distance between the center of the urethra and the levator insertion (LUG) in cm
Morphometry with ultrasound muscle thickness
时间窗: 12 months after delivery
Right and left puborectal muscle thickness (mm) .
Physics activity level.
时间窗: 12 months after delivery
Open questions on Physics activity level.
Fear Avoidance Beliefs Questionnaire (Physical Activity/PA)
时间窗: 12 months after delivery
Fear-Avoidance Beliefs Questionnaire
Sexual Function.
时间窗: 12 months after delivery
Female Sexual Function Index FSFI-19 questionnaire
Urogynecological symptoms.
时间窗: 12 months after delivery
Pelvic Floor Impact Questionnaire (PFIQ-7)
次要结局
- Age(10-12 weeks after delivery)
- Body mass index (BMI)(12 months after delivery)
- Weight gain during pregnancy(10-12 weeks after delivery)
- Pelvic Organ Prolapse Quantification Examination (POP-Q)(12 months after delivery)
- Previous abdominal operation(10-12 weeks after delivery)
- Delivery mode(10-12 weeks after delivery)
- Baby's birth weight(10-12 weeks after delivery)
- Gastric bypass(10-12 weeks after delivery)
- Modified Oxford Grading Scale(12 months after delivery)
研究者
Rocio Montejo Rodriguez
PhD
Vastra Gotaland Region