Trials / Suspended
SuspendedNCT04125498
The S-CARE Trial: Manual Treatment for C-sections Scars, a Pilot Study.
- Status
- Suspended
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 50 (estimated)
- Sponsor
- Studio Osteopatico Busto Arsizio · Academic / Other
- Sex
- Female
- Age
- 18 Years – 45 Years
- Healthy volunteers
- Accepted
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).
Conditions
- Cesarean Section Complications
- Cesarean Section; Complications, Wound, Infection (Following Delivery)
Interventions
| Type | Name | Description |
|---|---|---|
| OTHER | Osteopathic treatment | Manual treatment that aims to release myofascial tensions |
| 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. |
Timeline
- Start date
- 2019-12-01
- Primary completion
- 2025-09-01
- Completion
- 2025-12-01
- First posted
- 2019-10-14
- Last updated
- 2022-04-01
Locations
1 site across 1 country: Italy
Source: ClinicalTrials.gov record NCT04125498. Inclusion in this directory is not an endorsement.