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

Studio Osteopatico Busto Arsizio

Status: Suspended

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

Treatments: Other: Osteopathic treatment; Other: Self-massage; Other: Placebo treatment

Study type: Interventional

Funder types: Other

Identifiers

NCT04125498

S-Care pilot

Details and patient eligibility

About

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

Full 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).

Enrollment: 50 estimated patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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50 participants in 4 patient groups

OMT

Active Comparator group

Description:

Osteopathic manual treatment

Treatment:

Other: Osteopathic treatment

OMT plus self-massage

Active Comparator group

Description:

Patients will be submitted to OMT and then they will be invited to practice a self-massage at home.

Treatment:

Other: Osteopathic treatment

Other: Self-massage

Placebo

Sham Comparator group

Description:

Similar to OMT without pressure.

Treatment:

Other: Placebo treatment

Placebo plus self-massage

Active Comparator group

Description:

Patients will be submitted to placebo manual treatment and then they will be invited to practice a self-massage at home.

Treatment:

Other: Self-massage

Other: Placebo treatment