Cesarean Section ComplicationsS-CARENCT04125498
The S-CARE Trial: Manual Treatment for C-sections Scars, a Pilot Study.
A study testing Osteopathic treatment and Self-massage in people with Cesarean Section Complications and Cesarean Section; Complications, Wound, Infection (Following Delivery), run by Studio Osteopatico Busto Arsizio at 1 site in Italy.
Trial summary
This study aims to examine the effects of an osteopathic treatment on adhesions related to c-sections scars. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Cesarean Section Complications, Cesarean Section; Complications, Wound, Infection (Following Delivery)
- What is being tested?
- Osteopathic treatment and Self-massage
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteItaly
- Study dates
- 1 Dec 2019to 1 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
This study aims to examine the effects of an osteopathic treatment on adhesions related to c-sections scars.
Read the 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).
- Conditions
- Cesarean Section Complications, Cesarean Section; Complications, Wound, Infection (Following Delivery)
- Being tested
- Osteopathic treatment, Placebo treatment, Self-massage
- Keywords
- adhesions, cicatrix, c-section, scar, manual treatment
- Medical subject headings
- Wounds and Injuries, Infections, Tissue Adhesions, Cicatrix
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Osteopathic treatmentOther
Manual treatment that aims to release myofascial tensions
Placebo treatmentOther
Similar to OMT without pressure
Self-massageOther
Women will be instructed to perform self-massage at home once a day for 5 minutes.
| Study group | Role | What they receive |
|---|---|---|
| OMT | Active comparator | Osteopathic manual treatment Receives: Other: Osteopathic treatment |
| OMT plus self-massage | Active comparator | Patients will be submitted to OMT and then they will be invited to practice a self-massage at home. Receives: Other: Osteopathic treatment; Other: Self-massage |
| Placebo | Sham comparator | Similar to OMT without pressure. Receives: Other: Placebo treatment |
| Placebo plus self-massage | Active comparator | Patients will be submitted to placebo manual treatment and then they will be invited to practice a self-massage at home. Receives: Other: Placebo treatment; Other: Self-massage |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adhesions' number, size and vascularization
Evaluate through superb microvascular imaging. Correlation between adhesions and type/number of c-section
Measured: Changes from Baseline Adhesions' number, size and vascularization at 2 weeks and one month
Adverse event
Number and type of adverse events
Measured: Number of adverse event occurred at one month
Uterine niches
Evaluation of the presence and dimensions of uterine niches
Measured: Changes in dimension of uterine niches at one month
Secondary outcomes (4)
Reliability of osteopathic palpation through a questionnaire
Comparison between osteopathic palpation and ultrasound results in the detection of adhesions
Measured: At one week, two week and one month
Inter-reliability of ultrasound evaluation
Ultrasound results comparison between gynecologist and radiologist using a vascularization scale (grade from 0 to 4)
Measured: At one week, two week and one month
Self-massage compliance
Questionnaire
Measured: At one month
Symptoms related to scar
Measured: At one week, two week and one month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2019
- Study start1 Dec 2019
- Primary completion1 Sep 2025 (estimated)
- Study completion1 Dec 2025 (estimated)
Why it stopped: Recruitment during pandemic was impossible to achieve
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cesarean Section ComplicationsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- randomized triple-blinded
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Studio Osteopatico Busto Arsizio
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Carolina Lavazza, MSc, Principal investigator, Studio Osteopatico Busto Arsizio
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04125498
- Sponsor's protocol ID
- S-Care pilot
- Acronym
- S-CARE
- Status last verified
- Mar 2021
- First submitted
- 10 Oct 2019
- Last updated
- 1 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The S-CARE Trial: Manual Treatment for C-sections Scars, a Pilot Study.
- ClinicalTrials.gov ID
- NCT04125498
- Acronym / sponsor ID
- S-CARE / S-Care pilot
- Conditions
- Cesarean Section Complications, Cesarean Section; Complications, Wound, Infection (Following Delivery)
- Keywords
- adhesions, cicatrix, c-section, scar, manual treatment
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: Recruitment during pandemic was impossible to achieve
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Studio Osteopatico Busto ArsizioUniversity, hospital or other
- Study start
- 1 Dec 2019 (actual)
- Primary completion
- 1 Sep 2025 (estimated)
- Study completion
- 1 Dec 2025 (estimated)
- First posted
- 14 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
- Model description
- randomized triple-blinded
| Arm | Type | Receives |
|---|---|---|
| OMT | Active comparator | Other: Osteopathic treatmentOsteopathic manual treatment |
| OMT plus self-massage | Active comparator | Other: Osteopathic treatment, Other: Self-massagePatients will be submitted to OMT and then they will be invited to practice a self-massage at home. |
| Placebo | Sham comparator | Other: Placebo treatmentSimilar to OMT without pressure. |
| Placebo plus self-massage | Active comparator | Other: Placebo treatment, Other: Self-massagePatients will be submitted to placebo manual treatment and then they will be invited to practice a self-massage at home. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Osteopathic treatmentManual treatment that aims to release myofascial tensions | Other | OMT, OMT plus self-massage |
| Placebo treatmentSimilar to OMT without pressure | Other | Placebo, Placebo plus self-massage |
| Self-massageWomen will be instructed to perform self-massage at home once a day for 5 minutes. | Other | OMT plus self-massage, Placebo plus self-massage |
Primary outcome
Adhesions' number, size and vascularization
Time frame: 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
Time frame: Number of adverse event occurred at one month
Number and type of adverse events
Uterine niches
Time frame: Changes in dimension of uterine niches at one month
Evaluation of the presence and dimensions of uterine niches
4 secondary outcomes
Reliability of osteopathic palpation through a questionnaire
Time frame: At one week, two week and one month
Inter-reliability of ultrasound evaluation
Time frame: At one week, two week and one month
Self-massage compliance
Time frame: At one month
Symptoms related to scar
Time frame: At one week, two week and one month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2022.
- Individual participant dataSharing planned: No
Related trials for Cesarean Section Complications
Not yet recruiting
Comparison of Effect of Two Different Doses of Intravenous Oxytocin on Patients Undergoing Elective Cesarean Section
Postpartum Hemorrhage, Uterine Atony
Not yet recruitingObservational study
Ultrasound Assessment Of Gastric Volume In Pregnant Women Undergoing Elective Cesarean Section
Gestational Diabetes Mellitus (GDM), Obstetric Anesthesia
RecruitingPhase 1
Ketamine Pharmacokinetics and Pharmacodynamics for Postpartum Depression and Pain After Cesarean Delivery
Pain, Postpartum Depression
Recruiting
Clinical Impact of Uterine Repair During Cesarean Section With Barbed Suture on the Incidence of Isthmocele
Isthmocele, Cesarean Scar Defect
Not yet recruiting
The Mepilex Cesarean Delivery Trial / MEPIDEL
Surgical Site Infection
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Carolina Lavazza, MSc principal investigator
Studio Osteopatico Busto Arsizio
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Osteopathic treatment and Self-massage in people with Cesarean Section Complications and Cesarean Section; Complications, Wound, Infection (Following Delivery), run by Studio Osteopatico Busto Arsizio at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: paused, as of the sponsor's last update on 1 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adhesions' number, size and vascularization (time frame: Changes from Baseline Adhesions' number, size and vascularization at 2 weeks and one month). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2022.