Separated Recti AbdominisNCT06492603
Examination of Biomechanical Characteristics of Linea Alba in Diastasis Recti Patients
An observational study of Separated Recti Abdominis, run by South Valley University.
Trial summary
Diastasis recti is an increased distance between the rectus abdominis muscles at the midline caused by weakness in the anterior abdominal wall. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Separated Recti Abdominis
- What is being tested?
- Ultrasonography and The MyotonPRO Device
- Type of treatment
- Medical device
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 20 Jul 2025to 30 Dec 2025
- Phase
- Observational
- 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 40 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: 40 post-Cesarean women who are diagnosed with or without diastasis rectus abdominis. They will be selected from the teaching Hospitals of South Valley University.
Who may be able to join
- Postpartum Mothers who delivered by a cesarean section.
- Postpartum Mothers with a BMI below 30 or a Waist-hip ratio below 1.
- Postpartum Mothers above 18 years old and those below 40 years old.
Who cannot join
- Postpartum Mothers who delivered by a vaginal delivery.
- Postpartum Mothers who had hernias in the abdominal region or laparotomy.
- Postpartum Mothers with a BMI over 30 or a Waist-hip ratio over 1.
- Postpartum Mothers below 18 years old and those above 40 years old.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Examination of Linea Alba Biomechanical and Viscoelastic Characteristics in Patients Diagnosed With Diastasis Recti Using Ultrasound
Diastasis recti is an increased distance between the rectus abdominis muscles at the midline caused by weakness in the anterior abdominal wall.
Read the detailed description
Most healthcare providers agree that in diastasis rectus abdominis there is a weakness, thinning, and widening of the linea alba and weakness of the associated abdominal musculature.
Ultrasonography is regarded as the most accurate method for measuring the IRD and its results are consistent with the data derived from palpation, calipers, and intraoperative measurements.
The MyotonPRO Device is used for the non-invasive measurement of Device is for the non-invasive measurement of biomechanical and viscoelastic properties of superficial soft biological tissues. Skeletal muscles or tendons can be measured at different regions, at full rest or in contraction.
This study aims to assess the biomechanical and viscoelastic properties of the Linea Alba in patients who are diagnosed with diastasis rectus abdominis by ultrasonography.
- Conditions
- Separated Recti Abdominis
- Being tested
- Ultrasonography, The MyotonPRO Device
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UltrasonographyDevice
Ultrasound is an assessment device that uses high-energy sound waves to look at either superficial tissues like linea alba and/or organs inside the body. The sound waves make echoes that form pictures of the tissues and organs on a computer screen (sonogram).
The MyotonPRO DeviceDevice
The MyotonPro is a portable device for measuring biomechanical and viscoelastic properties in superficial soft tissues
| Study group | Role | What they receive |
|---|---|---|
| 20 Women in the Postpartum Diastasis Recti Group | Not described Receives: Device: Ultrasonography; Device: The MyotonPRO Device | |
| 20 Women in the Control Group (Postpartum Without Diastasis Recti) | Not described Receives: Device: Ultrasonography; Device: The MyotonPRO Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Linea Alba Stiffness
It is a Biomechanical Characteristic of the Linea Alba
Measured: Assessment will be done at the 7th day postpartum and at the end of the 6th week postpartum
Linea Alba Elasticity
It is a Biomechanical Characteristic of the Linea Alba
Measured: Assessment will be done at the 7th day postpartum and at the end of the 6th week postpartum
Linea Alba Creep
It is a Viscoelastic Characteristic of the Linea Alba
Measured: Assessment will be done at the 7th day postpartum and at the end of the 6th week postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2024
- Study start20 Jul 2025 (estimated)
- Primary completion20 Nov 2025 (estimated)
- Study completion30 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Separated Recti AbdominisStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- South Valley University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Gamal Abouelyazeed Ali, South Valley University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06492603
- Sponsor's protocol ID
- Diastasis Recti
- Status last verified
- Jul 2024
- First submitted
- 1 Jul 2024
- Last updated
- 3 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- 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 3 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Examination of Linea Alba Biomechanical and Viscoelastic Characteristics in Patients Diagnosed With Diastasis Recti Using Ultrasound
- ClinicalTrials.gov ID
- NCT06492603
- Acronym / sponsor ID
- Diastasis Recti
- Conditions
- Separated Recti Abdominis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- South Valley UniversityUniversity, hospital or other
- Study start
- 20 Jul 2025 (estimated)
- Primary completion
- 20 Nov 2025 (estimated)
- Study completion
- 30 Dec 2025 (estimated)
- First posted
- 9 Jul 2024 (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.
Diastasis recti is an increased distance between the rectus abdominis muscles at the midline caused by weakness in the anterior abdominal wall.
Detailed description
Most healthcare providers agree that in diastasis rectus abdominis there is a weakness, thinning, and widening of the linea alba and weakness of the associated abdominal musculature.
Ultrasonography is regarded as the most accurate method for measuring the IRD and its results are consistent with the data derived from palpation, calipers, and intraoperative measurements.
The MyotonPRO Device is used for the non-invasive measurement of Device is for the non-invasive measurement of biomechanical and viscoelastic properties of superficial soft biological tissues. Skeletal muscles or tendons can be measured at different regions, at full rest or in contraction.
This study aims to assess the biomechanical and viscoelastic properties of the Linea Alba in patients who are diagnosed with diastasis rectus abdominis by ultrasonography.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 20 Women in the Postpartum Diastasis Recti Group | – | Device: Ultrasonography, Device: The MyotonPRO Device |
| 20 Women in the Control Group (Postpartum Without Diastasis Recti) | – | Device: Ultrasonography, Device: The MyotonPRO Device |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- 40 post-Cesarean women who are diagnosed with or without diastasis rectus abdominis. They will be selected from the teaching Hospitals of South Valley University.
Key inclusion criteria (3 listed)
- Postpartum Mothers who delivered by a cesarean section.
- Postpartum Mothers with a BMI below 30 or a Waist-hip ratio below 1.
- Postpartum Mothers above 18 years old and those below 40 years old.
Key exclusion criteria (4 listed)
- Postpartum Mothers who delivered by a vaginal delivery.
- Postpartum Mothers who had hernias in the abdominal region or laparotomy.
- Postpartum Mothers with a BMI over 30 or a Waist-hip ratio over 1.
- Postpartum Mothers below 18 years old and those above 40 years old.
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 |
|---|---|---|
| UltrasonographyUltrasound is an assessment device that uses high-energy sound waves to look at either superficial tissues like linea alba and/or organs inside the body. The sound waves make echoes that form pictures of the tissues and organs on a computer screen (sonogram). | Device | 20 Women in the Control Group (Postpartum Without Diastasis Recti), 20 Women in the Postpartum Diastasis Recti Group |
| The MyotonPRO DeviceThe MyotonPro is a portable device for measuring biomechanical and viscoelastic properties in superficial soft tissues | Device | 20 Women in the Control Group (Postpartum Without Diastasis Recti), 20 Women in the Postpartum Diastasis Recti Group |
Primary outcome
Linea Alba Stiffness
Time frame: Assessment will be done at the 7th day postpartum and at the end of the 6th week postpartum
It is a Biomechanical Characteristic of the Linea Alba
Linea Alba Elasticity
Time frame: Assessment will be done at the 7th day postpartum and at the end of the 6th week postpartum
It is a Biomechanical Characteristic of the Linea Alba
Linea Alba Creep
Time frame: Assessment will be done at the 7th day postpartum and at the end of the 6th week postpartum
It is a Viscoelastic Characteristic of the Linea Alba
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2025.
- Individual participant dataSharing planned: No
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.
Questions about this trial
What is this clinical trial studying?
An observational study of Separated Recti Abdominis, run by South Valley University.
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: status not confirmed, as of the sponsor's last update on 3 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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?
Contact Mohamed G Shehata, Lecturer (01014397608, dr_m.gamal1987@svu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Linea Alba Stiffness (time frame: Assessment will be done at the 7th day postpartum and at the end of the 6th week postpartum). 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 3 Jul 2025.