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

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05709704
Acronym
DRA
Enrollment
150
Registered
2023-02-02
Start date
2021-07-02
Completion date
2023-05-31
Last updated
2023-02-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diastasis Recti

Keywords

Overall Function

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.

Interventions

DIAGNOSTIC_TESTSelf-palpation via telehealth

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

DIAGNOSTIC_TESTReal-time Ultrasound

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

Sponsors

Wichita State University
CollaboratorOTHER
Texas Woman's University
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 40 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Inventory of Functional Status after Childbirthone time between 6-10 weeks postpartumQuestionnaire used to measure a postpartum woman's ability to function within 5 different domains.

Secondary

MeasureTime frameDescription
Numeric Pain Scaleone time between 6-10 weeks postpartum0-10 scale for the participant to identify any areas of pain in various regions of the body
Oswestry Low Back Pain Disability Indexone time between 6-10 weeks postpartumA questionnaire to determine if the participant has any disability in the presence of low back pain
Pelvic Floor Distress Indexone time between 6-10 weeks postpartumQuestionnaire to determine if the participant has pelvic floor dysfunction

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026