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

Diastasis Recti Clinical Trial

— DRA  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05709704
• Other study ID #: IRB-FY2021-405
• Status: Recruiting
• Start date: July 2, 2021
• Est. completion date: May 2023

Study information

• Verified date: January 2023
• Source: Texas Woman's University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: May 2023
• Est. primary completion date: May 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Diastasis Recti
• Diastasis, Muscle

Intervention

Diagnostic Test:
• Self-palpation via telehealth
This will be used to determine if the participant has the diagnosis
• Real-time Ultrasound
This will be used in a subgroup of participants to confirm/rule out a diagnosis

Locations

Country	Name	City	State
United States	Wichita State University	Wichita	Kansas

Sponsors (2)

Lead Sponsor	Collaborator
Texas Woman's University	Wichita State University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Numeric Pain Scale	0-10 scale for the participant to identify any areas of pain in various regions of the body	one time between 6-10 weeks postpartum
Secondary	Oswestry Low Back Pain Disability Index	A questionnaire to determine if the participant has any disability in the presence of low back pain	one time between 6-10 weeks postpartum
Secondary	Pelvic Floor Distress Index	Questionnaire to determine if the participant has pelvic floor dysfunction	one time between 6-10 weeks postpartum