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

Sponsor

Studio Osteopatico Busto Arsizio (Other)

Overall Status

Suspended

CT.gov ID

NCT04125498

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

0.7

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Cesarean Section Complications Cesarean Section; Complications, Wound, Infection (Following Delivery)	Other: Osteopathic treatment Other: Placebo treatment Other: Self-massage	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

50 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

randomized triple-blindedrandomized triple-blinded

Masking:

Triple (Participant, Investigator, Outcomes Assessor)

Masking Description:

The gynecologist, the radiologist and the statistician will be blinded to group allocation. Participants will have similar manual treatments.

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Dec 1, 2019

Anticipated Primary Completion Date :

Sep 1, 2025

Anticipated Study Completion Date :

Dec 1, 2025

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: OMT Osteopathic manual treatment	Other: Osteopathic treatment Manual treatment that aims to release myofascial tensions
Active Comparator: OMT plus self-massage Patients will be submitted to OMT and then they will be invited to practice a self-massage at home.	Other: Osteopathic treatment Manual treatment that aims to release myofascial tensions Other: Self-massage Women will be instructed to perform self-massage at home once a day for 5 minutes.
Sham Comparator: Placebo Similar to OMT without pressure.	Other: Placebo treatment Similar to OMT without pressure
Active Comparator: Placebo plus self-massage Patients will be submitted to placebo manual treatment and then they will be invited to practice a self-massage at home.	Other: Placebo treatment Similar to OMT without pressure Other: Self-massage Women will be instructed to perform self-massage at home once a day for 5 minutes.

Outcome Measures

Primary Outcome Measures

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

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 45 Years

Sexes Eligible for Study:

Female

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Studio Osteopatico Busto Arsizio	Busto Arsizio	Varese	Italy

Sponsors and Collaborators

Studio Osteopatico Busto Arsizio

Investigators

Principal Investigator: Carolina Lavazza, MSc, Studio Osteopatico Busto Arsizio

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Studio Osteopatico Busto Arsizio

ClinicalTrials.gov Identifier:

NCT04125498

Other Study ID Numbers:

S-Care pilot

First Posted:

Oct 14, 2019

Last Update Posted:

Apr 1, 2022

Last Verified:

Mar 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Studio Osteopatico Busto Arsizio

Study Results

No Results Posted as of Apr 1, 2022