Clinical trial NCT05709704: Comparison of Overall Function Between Postpartum Women With and Without Diastasis Rectus Abdominis
Official title: Comparison of Overall Function Between Postpartum Women With and Without Diastasis Rectus Abdominis
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Diastasis Recti
Keywords: Overall Function
Lead sponsor: Texas Woman's University
Sponsor class: OTHER
Collaborators: name: Wichita State University
First posted: 2023-02-02
Enrollment: 150
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
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.

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.

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

Primary outcomes:
measure: Inventory of Functional Status after Childbirth
timeFrame: one time between 6-10 weeks postpartum
Secondary outcomes:
measure: Numeric Pain Scale
timeFrame: one time between 6-10 weeks postpartum
measure: Oswestry Low Back Pain Disability Index
timeFrame: one time between 6-10 weeks postpartum
measure: Pelvic Floor Distress Index
timeFrame: one time between 6-10 weeks postpartum
Other outcomes:
Locations:
city: Wichita
country: United States
facility: Wichita State University
state: Kansas
Study officials:
References: