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

NCT05709704 | Unknown

• 1 other identifier: IRB-FY2021-405
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Diastasis Recti

Keywords

Overall Function

Outcome Measures

Primary Outcomes (1)

• Inventory of Functional Status after Childbirth

  Questionnaire used to measure a postpartum woman's ability to function within 5 different domains.

  one time between 6-10 weeks postpartum

Secondary Outcomes (3)

• Numeric Pain Scale

  one time between 6-10 weeks postpartum

• Oswestry Low Back Pain Disability Index

  one time between 6-10 weeks postpartum

• Pelvic Floor Distress Index

  one time between 6-10 weeks postpartum

Study Arms (2)

Postpartum Women WITH DRA

Participants who have the diagnosis of diastasis rectus abdominis

Diagnostic Test: Self-palpation via telehealth; Diagnostic Test: Real-time Ultrasound

Postpartum Women WITHOUT DRA

Participants who do not have a diagnosis of diastasis rectus abdominis

Diagnostic Test: Self-palpation via telehealth; Diagnostic Test: Real-time Ultrasound

Interventions

Self-palpation via telehealth DIAGNOSTIC_TEST

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

Postpartum Women WITH DRA; Postpartum Women WITHOUT DRA

Real-time Ultrasound DIAGNOSTIC_TEST

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

Postpartum Women WITH DRA; Postpartum Women WITHOUT DRA

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

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. An announcement will also be included in the Wichita State University Shocker Blast and Strategic Communications. The recruitment fliers will ask interested women to email a research assistant to enroll in the research project.

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Texas Woman's University: lead
• Wichita State University: collaborator

Study Sites (1)

Wichita State University

Wichita, Kansas, 67260, United States

RECRUITING

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 7, 2022
• First Posted: February 2, 2023
• Study Start: July 2, 2021
• Primary Completion: May 1, 2023
• Study Completion: May 1, 2023
• Last Updated: February 2, 2023

Record last verified: 2023-01

Locations

US (1)