Comparison of Overall Function Between Postpartum Women With and Without Diastasis Rectus Abdominis

NCT ID: NCT05709704

Last Updated: 2023-02-02

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 150 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-07-02
• Study Completion Date: 2023-05-31

Brief Summary

The purpose of this research is to examine the effects of diastasis rectus abdominis on the overall function of postpartum women and to determine test-retest reliability and construct validity of a self-assessment palpation of inter-rectus distance for DRA using telehealth.

Detailed Description

Step 1: Recruitment

• The investigators will place recruitment fliers in local obstetrician offices, labor and delivery units in local hospitals, retail and daycare establishments, and on social media outlets such as Facebook, Instagram and Twitter.
• The recruitment fliers will ask interested women to email a student investigator to enroll in the research project.

Step 2: Collection of functional outcome data using a Qualtrics version of the Inventory of Functional Status After Childbirth (IFSAC), a demographic survey, a numeric pain reporting scale, Oswestry Low Back Pain Disability Questionnaire, and the Pelvic Floor Distress Index.

Step 3: A meeting time will be set up with every participant to conduct a telehealth visit with a research assistant. During this virtual visit on a private, password protected Zoom call the participant will be instructed on self-assessment palpation of the abdominal wall in order to determine the presence or absence of diastasis rectus abdominis (DRA) along the inter-rectus distance (IRD).

Step 4: The first 18 participants with self-assessed DRA and the first 18 participants without self-assessed DRA, who live in Wichita or surrounding areas, will be scheduled for a one-time in-person confirmation appointment. The appointment will last a maximum of 15 minutes and occur at the WSU Old Town campus room A106. During this confirmation appointment research assistants will screen the participant with the COVID Pre-screening Questions Tool, obtain written informed consent, check the participant in, collect height and weight, and the principal investigator will measure the participants abdominal wall using real-time ultrasound, measure the IRD using the PI's palpation method, and ask the participant to demonstrate and measure IRD using the same palpation method used on the telehealth visit. See the virus protection plan for details of which all participants and investigators will follow in order to minimize risks related to COVID-19).

Step 5: The data will be entered into SPSS and analyzed with appropriate statistical analyses.

Conditions

Diastasis Recti

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

Postpartum Women WITH DRA

Participants who have the diagnosis of diastasis rectus abdominis

Self-palpation via telehealth

Intervention Type: DIAGNOSTIC_TEST

This will be used to determine if the participant has the diagnosis

Real-time Ultrasound

Intervention Type: DIAGNOSTIC_TEST

This will be used in a subgroup of participants to confirm/rule out a diagnosis

Postpartum Women WITHOUT DRA

Participants who do not have a diagnosis of diastasis rectus abdominis

Self-palpation via telehealth

Intervention Type: DIAGNOSTIC_TEST

This will be used to determine if the participant has the diagnosis

Real-time Ultrasound

Intervention Type: DIAGNOSTIC_TEST

This will be used in a subgroup of participants to confirm/rule out a diagnosis

Interventions

Self-palpation via telehealth

This will be used to determine if the participant has the diagnosis

Intervention Type: DIAGNOSTIC_TEST

Real-time Ultrasound

This will be used in a subgroup of participants to confirm/rule out a diagnosis

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

Inclusion Criteria

• Women ages 18-40 years
• Postpartum (within 6-10 weeks of vaginal delivery)

Exclusion Criteria

• Women who are currently being treated by a physical therapist for their diastasis rectus abdominis
• Women who had high-risk pregnancies (bedrest, gestational diabetes, pregnancy-induced hypertension)
• Women with a history of abdominal or back surgery
• Women with history of connective tissue disease such as Ehlers-Danlos Syndrome

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Wichita State University

OTHER

Sponsor Role: collaborator

Texas Woman's University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Wichita State University

Wichita, Kansas, United States

Site Status: RECRUITING

Countries

United States

Facility Contacts

Jennifer Celso, DPT

Role: primary

jennifer.celso@wichita.edu

316-978-5648

Other Identifiers

IRB-FY2021-405

Identifier Type: -

Identifier Source: org_study_id