The S-CARE Trial: Manual Treatment for C-sections Scars, a Pilot Study.
试验速览
- 阶段
- 不适用
- 状态
- 暂停
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Adhesions' number, size and vascularization
研究概览
简要总结
This study aims to examine the effects of an osteopathic treatment on adhesions related to c-sections scars.
详细描述
The rates of caesarean sections are growing throughout the world, with recent rates (in 2016) in Europe of 25%, in North America of 32.3% and in South America of 40.5%.
The incidence of intra-abdominal adhesions in women undergoing to repeated caesarean sections is constantly increasing.
Labor and surgical time are significantly longer in patients with adhesions compared to patients without adhesions.
Furthermore, it has been estimated that about 10% of patients undergoing cesarean section experience chronic pain.
Despite of the big impact on the quality of life of patients and high cost for public health, treatments for adhesions are mostly surgical.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
The gynecologist, the radiologist and the statistician will be blinded to group allocation.
Participants will have similar manual treatments.
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •primiparous or multipara who have undergone a cesarean section with a completely healed scar will be included.
- •women who had first menstruation after childbirth
- •Women with or without pain or symptoms related to scarring or the presence of isthmocele will be included.
排除标准
- •caesarean section performed in a period less than 6 months and over 3 years
- •uterine prolapse
- •scar treatments already performed (both manual and medical)
- •absence of scar adhesions
研究组 & 干预措施
Placebo
Similar to OMT without pressure.
干预措施: Placebo treatment (Other)
OMT plus self-massage
Patients will be submitted to OMT and then they will be invited to practice a self-massage at home.
干预措施: Osteopathic treatment (Other)
OMT plus self-massage
Patients will be submitted to OMT and then they will be invited to practice a self-massage at home.
干预措施: Self-massage (Other)
OMT
Osteopathic manual treatment
干预措施: Osteopathic treatment (Other)
Placebo plus self-massage
Patients will be submitted to placebo manual treatment and then they will be invited to practice a self-massage at home.
干预措施: Placebo treatment (Other)
Placebo plus self-massage
Patients will be submitted to placebo manual treatment and then they will be invited to practice a self-massage at home.
干预措施: Self-massage (Other)
结局指标
主要结局
Adhesions' number, size and vascularization
时间窗: Changes from Baseline Adhesions' number, size and vascularization at 2 weeks and one month
Evaluate through superb microvascular imaging. Correlation between adhesions and type/number of c-section
Adverse event
时间窗: Number of adverse event occurred at one month
Number and type of adverse events
Uterine niches
时间窗: Changes in dimension of uterine niches at one month
Evaluation of the presence and dimensions of uterine niches
次要结局
- Inter-reliability of ultrasound evaluation(At one week, two week and one month)
- Self-massage compliance(At one month)
- Symptoms related to scar(At one week, two week and one month)
- Reliability of osteopathic palpation through a questionnaire(At one week, two week and one month)