Diastasis RectiNCT07442487
Effect of High Intensity Focused Electromagnetic Field on Postnatal Diastasis Recti
A study testing A program of abdominal exercises and High-intensity focused electromagnetic field in people with Diastasis Recti, run by Cairo University.
Trial summary
This study will be conducted to investigate the effect of high-intensity focused electromagnetic field on postnatal diastasis recti. Read more about this study
- Who is it for?
- Ages 25 to 35 years, women only
- Conditions the study is for
- Diastasis Recti
- What is being tested?
- A program of abdominal exercises and High-intensity focused electromagnetic field
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2026to 15 May 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 25 to 35 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Postnatal women (6 months after delivery) having diastasis recti (separation between the two recti more than 2.5cm at the level of umbilicus) diagnosed and referred from the obstetrician.
- Multiparous women (2-3) times delivered vaginally with or without episiotomy.
- Their ages will range from 25 -35 years old.
- Their BMI will be less than 30 kg/cm2.
- All women will be of sedentary lifestyle.
- They will be clinically and medically stable when attending the study.
Who cannot join
- Cardiac disorders.
- Active cancer.
- Medical condition contraindicating the application of an electromagnetic field as epilepsy or having metal implants
- Abdominal or back surgery.
- Abdominal hernia.
- History of abnormal pregnancy, uterine fibroid or polyhydramnios during pregnancy.
- Neurological disorders as multiple sclerosis, stroke and spinal lesion.
- Musculoskeletal diseases such as fractures and muscle strains which may affect their physical activity.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Manal Ahmed El-Shafei Mohamed, PhD contact
About this study
This study will be conducted to investigate the effect of high-intensity focused electromagnetic field on postnatal diastasis recti.
Read the detailed description
Rectus diastasis is a prevalent condition that can have adverse health implications for women during both the antenatal and postnatal periods of pregnancy. Diastasis rectus abdominis (DRA) has been found to affect between 30% and 70% of pregnant women, and the increased inter rectus diastasis (IRD) can persist separated in the immediate postpartum period in 35% to 60% of women.
The contraction of all abdominal muscles reduces the abdominal horizontal diameter in such a way that a horizontal force will be generated, producing the approximation of both rectus abdominis muscles, particularly at umbilical level. So, increasing the abdominal muscles strength have proven to bring the left and right sides of the rectus diastasis together, convert the abdomen into a rigid cylinder and minimize the additional stress on the trunk or back.
High-intensity focused electromagnetic technology induces a rapidly changing magnetic field that triggers supramaximal abdominal muscle contractions, not achievable voluntarily. In response, the abdominal muscles grow and strengthen, which lead to a tighter abdomen; thus, increasing the strength and the contour of the abdominal muscles.
To date, few investigations have been conducted to evaluate the effects of high-intensity focused electromagnetic field on changes in the abdominal subcutaneous fat, thickness and separation. But, till now there is no previous study investigated its effect on diastasis recti in postnatal women. Hence, the present study will be conducted to examine the effect of high-intensity focused electromagnetic field on diastasis recti in postnatal women which is anticipated to offer significant benefits to medical service organizations and contribute to the expanding knowledge base of physical therapists in the scientific domain.
- Conditions
- Diastasis Recti
- Being tested
- A program of abdominal exercises, High-intensity focused electromagnetic field
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
A program of abdominal exercisesOther
All women in both groups will be adhered to a program of abdominal strengthening exercise that includes static abdominal, abdominal crunch, and external oblique exercises. Each exercise will be repeated 15 times and will be increased by five repetitions each week throughout the study period, with total time of 20 minutes/ session, 3 times weekly for 8 weeks.
High-intensity focused electromagnetic fieldDevice
High-intensity focused electromagnetic field will be administered only to the experimental group, targeting the abdominal region for 30 minutes per session, twice weekly for 8 weeks. Sessions will be performed in the supine position, with the applicator centered over the umbilicus and secured to prevent movement. Stimulation intensity will start at 0% and be gradually increased to achieve strong yet tolerable muscle contractions, guided by continuous visual monitoring and patient feedback to ensure comfort and uniform abdominal activation.
| Study group | Role | What they receive |
|---|---|---|
| A program of abdominal exercises | Active comparator | It will consist of 21 postpartum women who will only participate into a program of abdominal exercises, 20 minutes, 3 times /week for 8 weeks. Receives: Other: A program of abdominal exercises |
| High-intensity focused electromagnetic field + A program of abdominal exercises | Experimental | It will consist of 21 postpartum women who will receive high-intensity focused electromagnetic field for 30 minutes, 2 times /week for 8 weeks, in addition to a program of abdominal exercises for 20 minutes, 3 times /week for 8 weeks. Receives: Other: A program of abdominal exercises; Device: High-intensity focused electromagnetic field |
What is being measured
The primary outcome is the main question the study is designed to answer.
Inter-recti distance (IRD) 3 cm above the umbilicus
IRD at 3 cm above the umbilicus will be measured using diagnostic ultrasound to assess upper abdominal rectus separation. Assessments will be performed at baseline and after 8 weeks for both groups by the same radiologist. Participants will be positioned in relaxed crook-lying, with the transducer placed perpendicular to the linea alba. Measurements will be taken at the end of normal expiration.
Measured: 8 weeks
Inter-recti distance at the level of the umbilicus
IRD at the umbilical level will be evaluated using real-time ultrasound at baseline and post-intervention for all participants. Examinations will be conducted by the same radiologist under standardized conditions. With participants in a relaxed crook-lying position, the transducer will be positioned over the umbilicus, and IRD will be measured between the medial borders of the rectus muscles at end-expiration.
Measured: 8 weeks
Inter-recti distance 3 cm below the umbilicus
IRD 3 cm below the umbilicus will be assessed by ultrasound to reflect lower abdominal rectus separation. Measurements will be obtained at baseline and after 8 weeks for both groups by the same radiologist. Participants will lie in a supported crook-lying position, with the transducer placed perpendicular to the linea alba, and readings taken at the end of normal expiration.
Measured: 8 weeks
Right rectus abdominis muscle thickness
Thickness of the right rectus abdominis will be measured using ultrasound at baseline and after 8 weeks for all participants. Assessments will be conducted by the same radiologist with participants in a relaxed crook-lying position. The probe will be placed perpendicular at the umbilical-midintercostal intersection, and measurements will be taken at the end of normal expiration.
Measured: 8 weeks
Left rectus abdominis muscle thickness
Ultrasound will be used to assess left rectus abdominis thickness before and after the 8-week intervention in both groups. Measurements will be performed by the same radiologist with participants in a supported crook-lying position. The transducer will be positioned perpendicular at the standardized anatomical landmark, and images will be captured at end-expiration.
Measured: 8 weeks
Right external oblique muscle thickness
Right external oblique muscle thickness will be evaluated using diagnostic ultrasound at baseline and post-intervention. All measurements will be performed by the same radiologist with participants in a relaxed crook-lying position. The probe will be placed perpendicular at the designated site, and readings will be recorded at the end of normal expiration.
Measured: 8 weeks
Left external oblique muscle thickness
Thickness of the left external oblique muscle will be assessed by ultrasound at baseline and after 8 weeks. Examinations will be conducted by the same radiologist with participants in a supported crook-lying position. The transducer will be positioned perpendicularly at the standardized location, and measurements will be obtained at end-expiration.
Measured: 8 weeks
Secondary outcomes (2)
one-minute sit-up test
Abdominal muscle strength and endurance will be evaluated before and after the intervention using the one-minute sit-up test. Participants will lie supine with knees flexed and feet stabilized, then perform as many sit-ups as possible within one minute. Each repetition involves touching the knees with the elbows and returning to the floor. The total number of repetitions will be recorded, with higher scores indicating greater abdominal strength and endurance.
Measured: 8 weeks
Inventory of Functional Status After Childbirth (IFSAC) questionnaire
Functional status will be assessed using the Inventory of Functional Status After Childbirth (IFSAC) questionnaire. All participants in Groups A and B will complete the questionnaire at baseline and after completion of the study program. The IFSAC is a validated and reliable instrument designed to evaluate postpartum functional performance across five domains: infant care, personal care, household activities, social and community participation, and occupational activities. The questionnaire consists of 36 items rated on a four-point scale, with higher mean scores indicating better functional status.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2026
- Study start1 Mar 2026 (estimated)
- Primary completion1 May 2026 (estimated)
- Study completion15 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diastasis RectiStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 42 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Salsabil Ahmed Hassan, Cairo University
- Investigators
- Soheir Mahmoud El-Kosery, PhD, Study chair, Professor, Cairo UniversityManal Ahmed El-Shafei Mohamed, PhD, Study director, Ass. Professor, Cairo UniversityMohammed Fathi Abo Hashim, PhD, Study director, Assis. Professor, Zagazig University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07442487
- Sponsor's protocol ID
- P.T.REC/012/005282
- Status last verified
- Feb 2026
- First submitted
- 24 Feb 2026
- Last updated
- 2 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of High Intensity Focused Electromagnetic Field on Postnatal Diastasis Recti
- ClinicalTrials.gov ID
- NCT07442487
- Acronym / sponsor ID
- P.T.REC/012/005282
- Conditions
- Diastasis Recti
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 42 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Mar 2026 (estimated)
- Primary completion
- 1 May 2026 (estimated)
- Study completion
- 15 May 2026 (estimated)
- First posted
- 2 Mar 2026 (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 will be conducted to investigate the effect of high-intensity focused electromagnetic field on postnatal diastasis recti.
Detailed description
Rectus diastasis is a prevalent condition that can have adverse health implications for women during both the antenatal and postnatal periods of pregnancy. Diastasis rectus abdominis (DRA) has been found to affect between 30% and 70% of pregnant women, and the increased inter rectus diastasis (IRD) can persist separated in the immediate postpartum period in 35% to 60% of women.
The contraction of all abdominal muscles reduces the abdominal horizontal diameter in such a way that a horizontal force will be generated, producing the approximation of both rectus abdominis muscles, particularly at umbilical level. So, increasing the abdominal muscles strength have proven to bring the left and right sides of the rectus diastasis together, convert the abdomen into a rigid cylinder and minimize the additional stress on the trunk or back.
High-intensity focused electromagnetic technology induces a rapidly changing magnetic field that triggers supramaximal abdominal muscle contractions, not achievable voluntarily. In response, the abdominal muscles grow and strengthen, which lead to a tighter abdomen; thus, increasing the strength and the contour of the abdominal muscles.
To date, few investigations have been conducted to evaluate the effects of high-intensity focused electromagnetic field on changes in the abdominal subcutaneous fat, thickness and separation. But, till now there is no previous study investigated its effect on diastasis recti in postnatal women. Hence, the present study will be conducted to examine the effect of high-intensity focused electromagnetic field on diastasis recti in postnatal women which is anticipated to offer significant benefits to medical service organizations and contribute to the expanding knowledge base of physical therapists in the scientific domain.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A program of abdominal exercises | Active comparator | Other: A program of abdominal exercisesIt will consist of 21 postpartum women who will only participate into a program of abdominal exercises, 20 minutes, 3 times /week for 8 weeks. |
| High-intensity focused electromagnetic field + A program of abdominal exercises | Experimental | Other: A program of abdominal exercises, Device: High-intensity focused electromagnetic fieldIt will consist of 21 postpartum women who will receive high-intensity focused electromagnetic field for 30 minutes, 2 times /week for 8 weeks, in addition to a program of abdominal exercises for 20 minutes, 3 times /week for 8 weeks. |
Who may qualify
- Ages
- 25 to 35 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Postnatal women (6 months after delivery) having diastasis recti (separation between the two recti more than 2.5cm at the level of umbilicus) diagnosed and referred from the obstetrician.
- Multiparous women (2-3) times delivered vaginally with or without episiotomy.
- Their ages will range from 25 -35 years old.
- Their BMI will be less than 30 kg/cm2.
- All women will be of sedentary lifestyle.
Key exclusion criteria (8 listed)
- Cardiac disorders.
- Active cancer.
- Medical condition contraindicating the application of an electromagnetic field as epilepsy or having metal implants
- Abdominal or back surgery.
- Abdominal hernia.
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 |
|---|---|---|
| A program of abdominal exercisesAll women in both groups will be adhered to a program of abdominal strengthening exercise that includes static abdominal, abdominal crunch, and external oblique exercises. Each exercise will be repeated 15 times and will be increased by five repetitions each week throughout the study period, with total time of 20 minutes/ session, 3 times weekly for 8 weeks. | Other | A program of abdominal exercises, High-intensity focused electromagnetic field + A program of abdominal exercises |
| High-intensity focused electromagnetic fieldHigh-intensity focused electromagnetic field will be administered only to the experimental group, targeting the abdominal region for 30 minutes per session, twice weekly for 8 weeks. Sessions will be performed in the supine position, with the applicator centered over the umbilicus and secured to prevent movement. Stimulation intensity will start at 0% and be gradually increased to achieve strong yet tolerable muscle contractions, guided by continuous visual monitoring and patient feedback to ensure comfort and uniform abdominal activation. | Device | High-intensity focused electromagnetic field + A program of abdominal exercises |
Primary outcome
Inter-recti distance (IRD) 3 cm above the umbilicus
Time frame: 8 weeks
IRD at 3 cm above the umbilicus will be measured using diagnostic ultrasound to assess upper abdominal rectus separation. Assessments will be performed at baseline and after 8 weeks for both groups by the same radiologist. Participants will be positioned in relaxed crook-lying, with the transducer placed perpendicular to the linea alba. Measurements will be taken at the end of normal expiration.
Inter-recti distance at the level of the umbilicus
Time frame: 8 weeks
IRD at the umbilical level will be evaluated using real-time ultrasound at baseline and post-intervention for all participants. Examinations will be conducted by the same radiologist under standardized conditions. With participants in a relaxed crook-lying position, the transducer will be positioned over the umbilicus, and IRD will be measured between the medial borders of the rectus muscles at end-expiration.
Inter-recti distance 3 cm below the umbilicus
Time frame: 8 weeks
IRD 3 cm below the umbilicus will be assessed by ultrasound to reflect lower abdominal rectus separation. Measurements will be obtained at baseline and after 8 weeks for both groups by the same radiologist. Participants will lie in a supported crook-lying position, with the transducer placed perpendicular to the linea alba, and readings taken at the end of normal expiration.
Right rectus abdominis muscle thickness
Time frame: 8 weeks
Thickness of the right rectus abdominis will be measured using ultrasound at baseline and after 8 weeks for all participants. Assessments will be conducted by the same radiologist with participants in a relaxed crook-lying position. The probe will be placed perpendicular at the umbilical-midintercostal intersection, and measurements will be taken at the end of normal expiration.
Left rectus abdominis muscle thickness
Time frame: 8 weeks
Ultrasound will be used to assess left rectus abdominis thickness before and after the 8-week intervention in both groups. Measurements will be performed by the same radiologist with participants in a supported crook-lying position. The transducer will be positioned perpendicular at the standardized anatomical landmark, and images will be captured at end-expiration.
Right external oblique muscle thickness
Time frame: 8 weeks
Right external oblique muscle thickness will be evaluated using diagnostic ultrasound at baseline and post-intervention. All measurements will be performed by the same radiologist with participants in a relaxed crook-lying position. The probe will be placed perpendicular at the designated site, and readings will be recorded at the end of normal expiration.
Left external oblique muscle thickness
Time frame: 8 weeks
Thickness of the left external oblique muscle will be assessed by ultrasound at baseline and after 8 weeks. Examinations will be conducted by the same radiologist with participants in a supported crook-lying position. The transducer will be positioned perpendicularly at the standardized location, and measurements will be obtained at end-expiration.
2 secondary outcomes
one-minute sit-up test
Time frame: 8 weeks
Inventory of Functional Status After Childbirth (IFSAC) questionnaire
Time frame: 8 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2026.
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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.
Manal Ahmed El-Shafei Mohamed, PhD contact
Soheir Mahmoud El-Kosery, PhD study chair
Professor, Cairo University
Manal Ahmed El-Shafei Mohamed, PhD study director
Ass. Professor, Cairo University
Mohammed Fathi Abo Hashim, PhD study director
Assis. Professor, Zagazig University
Questions about this trial
What is this clinical trial studying?
A study testing A program of abdominal exercises and High-intensity focused electromagnetic field in people with Diastasis Recti, run by Cairo 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 6 inclusion and 8 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: opening soon, as of the sponsor's last update on 2 Mar 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Salsabil Ahmed Hassan, B.Sc (+20 10 68030335, salsabiloraby5@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Inter-recti distance (IRD) 3 cm above the umbilicus (time frame: 8 weeks). The study lists 7 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 2 Mar 2026; AzTrials last refreshed its copy on 6 Nov 2026.