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

Cesarean Section Complications Clinical Trial

— S-CARE  

Official title:

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

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT04125498
• Other study ID #: S-Care pilot
• Status: Suspended
• Phase: N/A
• Start date: December 1, 2019
• Est. completion date: December 1, 2025

Study information

• Verified date: March 2021
• Source: Studio Osteopatico Busto Arsizio
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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).

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 50
• Est. completion date: December 1, 2025
• Est. primary completion date: September 1, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Other:
• Osteopathic treatment
Manual treatment that aims to release myofascial tensions
• Placebo treatment
Similar to OMT without pressure
• Self-massage
Women will be instructed to perform self-massage at home once a day for 5 minutes.

Locations

Country	Name	City	State
Italy	Studio Osteopatico Busto Arsizio	Busto Arsizio	Varese

Sponsors (1)

Lead Sponsor	Collaborator
Studio Osteopatico Busto Arsizio

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Adverse event	Number and type of adverse events	Number of adverse event occurred at one month
Primary	Uterine niches	Evaluation of the presence and dimensions of uterine niches	Changes in dimension of uterine niches at one month
Secondary	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
Secondary	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
Secondary	Self-massage compliance	Questionnaire	At one month
Secondary	Symptoms related to scar		At one week, two week and one month