The S-CARE Trial: Manual Treatment for C-sections Scars, a Pilot Study.

Study Overview
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Brief Summary
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This study aims to examine the effects of an osteopathic treatment on adhesions related to c-sections scars.

Detailed Description
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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. The identification of non-surgical treatments that aim to reduce cicatricial adhesions' formation is essential to decrease hospitalization times and associated complications. The purpose of this study is to evaluate the effects of osteopathic treatment and self-massage on scars in women who underwent to a cesarean section. The main aim is to assess whether there is a change in the number, size and vascularization of of cesarean section adhesionsthrough Superb Microvascular Imaging (SMI).

Official Title
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The S-CARE Trial: Manual Treatment for C-sections Scars, a Pilot Study.

Conditions
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Cesarean Section Complications, Cesarean Section; Complications, Wound, Infection (Following Delivery)

Intervention / Treatment
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* Other: Osteopathic treatment
* Other: Placebo treatment
* Other: Self-massage


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: randomized triple-blinded
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: OMT<br>Osteopathic manual treatment | Other: Osteopathic treatment<br>* Manual treatment that aims to release myofascial tensions<br>|
| Active Comparator: OMT plus self-massage<br>Patients will be submitted to OMT and then they will be invited to practice a self-massage at home. | Other: Osteopathic treatment<br>* Manual treatment that aims to release myofascial tensions<br>Other: Self-massage<br>* Women will be instructed to perform self-massage at home once a day for 5 minutes.<br>|
| Sham Comparator: Placebo<br>Similar to OMT without pressure. | Other: Placebo treatment<br>* Similar to OMT without pressure<br>|
| Active Comparator: Placebo plus self-massage<br>Patients will be submitted to placebo manual treatment and then they will be invited to practice a self-massage at home. | Other: Placebo treatment<br>* Similar to OMT without pressure<br>Other: Self-massage<br>* Women will be instructed to perform self-massage at home once a day for 5 minutes.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adhesions' number, size and vascularization | Evaluate through superb microvascular imaging. Correlation between adhesions and type/number of c-section | Changes from Baseline Adhesions' number, size and vascularization at 2 weeks and one month | 
| Adverse event | Number and type of adverse events | Number of adverse event occurred at one month | 
| Uterine niches | Evaluation of the presence and dimensions of uterine niches | Changes in dimension of uterine niches at one month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reliability of osteopathic palpation through a questionnaire | Comparison between osteopathic palpation and ultrasound results in the detection of adhesions | At one week, two week and one month | 
| Inter-reliability of ultrasound evaluation | Ultrasound results comparison between gynecologist and radiologist using a vascularization scale (grade from 0 to 4) | At one week, two week and one month | 
| Self-massage compliance | Questionnaire | At one month | 
| Symptoms related to scar |  | At one week, two week and one month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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adhesions, cicatrix, c-section, scar, manual treatment