Cesarean Section Complications, Cesarean Section; Complications, Wound, Infection (Following Delivery)
Conditions
Keywords
adhesions, cicatrix, c-section, scar, manual treatment
Brief summary
This study aims to examine the effects of an osteopathic treatment on adhesions related to c-sections scars.
Detailed description
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).
Interventions
Manual treatment that aims to release myofascial tensions
OTHERPlacebo treatment
Similar to OMT without pressure
OTHERSelf-massage
Women will be instructed to perform self-massage at home once a day for 5 minutes.
Sponsors
Studio Osteopatico Busto Arsizio
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Masking description
The gynecologist, the radiologist and the statistician will be blinded to group allocation. Participants will have similar manual treatments.
Intervention model description
randomized triple-blinded
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adhesions' number, size and vascularization | 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 | Number of adverse event occurred at one month | Number and type of adverse events |
| Uterine niches | Changes in dimension of uterine niches at one month | Evaluation of the presence and dimensions of uterine niches |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Symptoms related to scar | At one week, two week and one month | — |
| Self-massage compliance | At one month | Questionnaire |
| Reliability of osteopathic palpation through a questionnaire | At one week, two week and one month | Comparison between osteopathic palpation and ultrasound results in the detection of adhesions |
| Inter-reliability of ultrasound evaluation | At one week, two week and one month | Ultrasound results comparison between gynecologist and radiologist using a vascularization scale (grade from 0 to 4) |
Countries
Italy
Outcome results
None listed