Clinical trial NCT04125498: The S-CARE Trial: Manual Treatment for C-sections Scars, a Pilot Study.
Official title: The S-CARE Trial: Manual Treatment for C-sections Scars, a Pilot Study.
Study type: INTERVENTIONAL
Overall status: SUSPENDED
Phase: NA
Conditions: Cesarean Section Complications
Cesarean Section; Complications, Wound, Infection (Following Delivery)
Keywords: adhesions
cicatrix
c-section
scar
manual treatment
Lead sponsor: Studio Osteopatico Busto Arsizio
Sponsor class: OTHER
First posted: 2019-10-14
Enrollment: 50
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: randomized triple-blinded
Primary purpose: 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).

Eligibility criteria: 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

Primary outcomes:
measure: Adhesions' number, size and vascularization
timeFrame: Changes from Baseline Adhesions' number, size and vascularization at 2 weeks and one month
measure: Adverse event
timeFrame: Number of adverse event occurred at one month
measure: Uterine niches
timeFrame: Changes in dimension of uterine niches at one month
Secondary outcomes:
measure: Reliability of osteopathic palpation through a questionnaire
timeFrame: At one week, two week and one month
measure: Inter-reliability of ultrasound evaluation
timeFrame: At one week, two week and one month
measure: Self-massage compliance
timeFrame: At one month
measure: Symptoms related to scar
timeFrame: At one week, two week and one month
Other outcomes:
Locations:
city: Busto Arsizio
country: Italy
facility: Studio Osteopatico Busto Arsizio
state: Varese
Study officials:
affiliation: Studio Osteopatico Busto Arsizio
name: Carolina Lavazza, MSc
role: PRINCIPAL_INVESTIGATOR
References: