NCT06492603

Brief Summary

Diastasis recti is an increased distance between the rectus abdominis muscles at the midline caused by weakness in the anterior abdominal wall.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jul 2025

Shorter than P25 for all trials

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 1, 2024

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 9, 2024

Completed
1 year until next milestone

Study Start

First participant enrolled

July 20, 2025

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 20, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2025

Completed
Last Updated

July 3, 2025

Status Verified

July 1, 2024

Enrollment Period

4 months

First QC Date

July 1, 2024

Last Update Submit

June 30, 2025

Conditions

Outcome Measures

Primary Outcomes (3)

  • Linea Alba Stiffness

    It is a Biomechanical Characteristic of the Linea Alba

    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

    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

    Assessment will be done at the 7th day postpartum and at the end of the 6th week postpartum

Study Arms (2)

20 Women in the Postpartum Diastasis Recti Group

Device: UltrasonographyDevice: The MyotonPRO Device

20 Women in the Control Group (Postpartum Without Diastasis Recti)

Device: UltrasonographyDevice: The MyotonPRO Device

Interventions

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).

20 Women in the Control Group (Postpartum Without Diastasis Recti)20 Women in the Postpartum Diastasis Recti Group

The MyotonPro is a portable device for measuring biomechanical and viscoelastic properties in superficial soft tissues

20 Women in the Control Group (Postpartum Without Diastasis Recti)20 Women in the Postpartum Diastasis Recti Group

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsThis study examines the Biomechanical and Viscoelastic Characteristics of Diastasis Rectus Abdominis in Postpartum Women
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
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.

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

Ultrasonography

Intervention Hierarchy (Ancestors)

Diagnostic ImagingDiagnostic Techniques and ProceduresDiagnosis

Central Study Contacts

Mohamed G Shehata, Lecturer

CONTACT

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer of Physical Therapy for Women's Health

Study Record Dates

First Submitted

July 1, 2024

First Posted

July 9, 2024

Study Start

July 20, 2025

Primary Completion

November 20, 2025

Study Completion

December 30, 2025

Last Updated

July 3, 2025

Record last verified: 2024-07

Data Sharing

IPD Sharing
Will not share