Effect of High Intensity Focused Electromagnetic Field on Postnatal Diastasis Recti

NCT07442487 | Not Yet Recruiting

• 1 other identifier: P.T.REC/012/005282
• Study Type: interventional
• Target: 42
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study will be conducted to investigate the effect of high-intensity focused electromagnetic field on postnatal diastasis recti.

Conditions

Diastasis Recti

Outcome Measures

Primary Outcomes (7)

• 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.

  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.

  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.

  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.

  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.

  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.

  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.

  8 weeks

Secondary Outcomes (2)

• one-minute sit-up test

  8 weeks

• Inventory of Functional Status After Childbirth (IFSAC) questionnaire

  8 weeks

Study Arms (2)

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.

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.

Other: A program of abdominal exercises; Device: High-intensity focused electromagnetic field

Interventions

A program of abdominal exercises OTHER

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.

A program of abdominal exercises; High-intensity focused electromagnetic field + A program of abdominal exercises

High-intensity focused electromagnetic field DEVICE

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.

High-intensity focused electromagnetic field + A program of abdominal exercises

Eligibility Criteria

• Age: 25 Years - 35 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cairo University: lead

Study Officials

• Soheir Mahmoud El-Kosery, PhD

  Professor, Cairo University

  STUDY CHAIR

• Manal Ahmed El-Shafei Mohamed, PhD

  Ass. Professor, Cairo University

  STUDY DIRECTOR

• Mohammed Fathi Abo Hashim, PhD

  Assis. Professor, Zagazig University

  STUDY DIRECTOR

Central Study Contacts

Salsabil Ahmed Hassan, B.Sc

CONTACT

+20 10 68030335; salsabiloraby5@gmail.com

Manal Ahmed El-Shafei Mohamed, PhD

CONTACT

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 24, 2026
• First Posted: March 2, 2026
• Study Start: March 1, 2026
• Primary Completion: May 1, 2026
• Study Completion: May 15, 2026
• Last Updated: March 2, 2026

Record last verified: 2026-02