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

Not Applicable

Suspended

• Conditions: Cesarean Section Complications; Cesarean Section; Complications, Wound, Infection (Following Delivery)
• Interventions: Other: Osteopathic treatment; Other: Placebo treatment; Other: Self-massage

• Registration Number: NCT04125498
• Lead Sponsor: Studio Osteopatico Busto Arsizio

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).

Study Timeline

• Study First Submitted: 2019-10-10
• Study First Submitted QC: 2019-10-11
• Study First Posted: 2019-10-14
• Study Start: 2019-12-01
• Status Verified: 2021-03
• Last Update Submitted: 2022-03-21
• Last Update Posted: 2022-04-01
• Primary Completion: 2025-09-01
• Study Completion: 2025-12-01

Recruitment & Eligibility

• Status: SUSPENDED
• Sex: Female
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo plus self-massage	Self-massage	Patients will be submitted to placebo manual treatment and then they will be invited to practice a self-massage at home.
OMT plus self-massage	Osteopathic treatment	Patients will be submitted to OMT and then they will be invited to practice a self-massage at home.
OMT	Osteopathic treatment	Osteopathic manual treatment
OMT plus self-massage	Self-massage	Patients will be submitted to OMT and then they will be invited to practice a self-massage at home.
Placebo	Placebo treatment	Similar to OMT without pressure.
Placebo plus self-massage	Placebo treatment	Patients will be submitted to placebo manual treatment and then they will be invited to practice a self-massage at home.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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)
Self-massage compliance	At one month	Questionnaire
Symptoms related to scar	At one week, two week and one month

Trial Locations

Locations (1)

Studio Osteopatico Busto Arsizio; 🇮🇹 Busto Arsizio, Varese, Italy