Diastasis RectiDRANCT05709704
Comparison of Overall Function Between Postpartum Women With and Without Diastasis Rectus Abdominis
An observational study of Diastasis Recti, run by Texas Woman's University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Diastasis Recti
- What is being tested?
- Self-palpation via telehealth and Real-time Ultrasound
- How many people
- 150 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Jul 2021to May 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
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.
Who may be able to join
- Women ages 18-40 years
- Postpartum (within 6-10 weeks of vaginal delivery)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Wichita State University
Wichita, Kansas, 67260
Jennifer Celso, DPT, 316-978-5648, jennifer.celso@wichita.edu
Jennifer Celso, DPT
About this study
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.
Read the 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
- Being tested
- Self-palpation via telehealth, Real-time Ultrasound
- Keywords
- Overall Function
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Self-palpation via telehealthDiagnostic test
This will be used to determine if the participant has the diagnosis
Real-time UltrasoundDiagnostic test
This will be used in a subgroup of participants to confirm/rule out a diagnosis
| Study group | Role | What they receive |
|---|---|---|
| Postpartum Women WITH DRA | Participants who have the diagnosis of diastasis rectus abdominis Receives: 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 Receives: Diagnostic Test: Self-palpation via telehealth; Diagnostic Test: Real-time Ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
Inventory of Functional Status after Childbirth
Questionnaire used to measure a postpartum woman's ability to function within 5 different domains.
Measured: one time between 6-10 weeks postpartum
Secondary outcomes (3)
Numeric Pain Scale
0-10 scale for the participant to identify any areas of pain in various regions of the body
Measured: one time between 6-10 weeks postpartum
Oswestry Low Back Pain Disability Index
A questionnaire to determine if the participant has any disability in the presence of low back pain
Measured: one time between 6-10 weeks postpartum
Pelvic Floor Distress Index
Questionnaire to determine if the participant has pelvic floor dysfunction
Measured: one time between 6-10 weeks postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2023
- Study start2 Jul 2021
- Primary completionMay 2023 (estimated)
- Study completionMay 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diastasis RectiStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Texas Woman's University
- Sponsor type
- University, hospital or other
- Collaborators
- Wichita State University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05709704
- Sponsor's protocol ID
- IRB-FY2021-405
- Acronym
- DRA
- Status last verified
- Jan 2023
- First submitted
- 7 Jul 2022
- Last updated
- 2 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Overall Function Between Postpartum Women With and Without Diastasis Rectus Abdominis
- ClinicalTrials.gov ID
- NCT05709704
- Acronym / sponsor ID
- DRA / IRB-FY2021-405
- Conditions
- Diastasis Recti
- Keywords
- Overall Function
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Texas Woman's UniversityUniversity, hospital or other
- Collaborators
- Wichita State University
- Study start
- 2 Jul 2021 (actual)
- Primary completion
- May 2023 (estimated)
- Study completion
- May 2023 (estimated)
- First posted
- 2 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Postpartum Women WITH DRA | – | Diagnostic Test: Self-palpation via telehealth, Diagnostic Test: Real-time UltrasoundParticipants who have the diagnosis of diastasis rectus abdominis |
| Postpartum Women WITHOUT DRA | – | Diagnostic Test: Self-palpation via telehealth, Diagnostic Test: Real-time UltrasoundParticipants who do not have a diagnosis of diastasis rectus abdominis |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (2 listed)
- Women ages 18-40 years
- Postpartum (within 6-10 weeks of vaginal delivery)
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Self-palpation via telehealthThis will be used to determine if the participant has the diagnosis | Diagnostic test | Postpartum Women WITH DRA, Postpartum Women WITHOUT DRA |
| Real-time UltrasoundThis will be used in a subgroup of participants to confirm/rule out a diagnosis | Diagnostic test | Postpartum Women WITH DRA, Postpartum Women WITHOUT DRA |
Primary outcome
Inventory of Functional Status after Childbirth
Time frame: one time between 6-10 weeks postpartum
Questionnaire used to measure a postpartum woman's ability to function within 5 different domains.
3 secondary outcomes
Numeric Pain Scale
Time frame: one time between 6-10 weeks postpartum
Oswestry Low Back Pain Disability Index
Time frame: one time between 6-10 weeks postpartum
Pelvic Floor Distress Index
Time frame: one time between 6-10 weeks postpartum
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2023.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diastasis Recti, run by Texas Woman's University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Inventory of Functional Status after Childbirth (time frame: one time between 6-10 weeks postpartum). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Feb 2023.