Ignite Creation Date:
2025-12-24 @ 7:56 PM
Ignite Modification Date:
2026-01-02 @ 2:03 AM
Study NCT ID:
NCT05709704
Status:
UNKNOWN
Last Update Posted:
2023-02-02
First Post:
2022-07-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of Overall Function Between Postpartum Women With and Without Diastasis Rectus Abdominis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 150}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-07-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-01', 'completionDateStruct': {'date': '2023-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-01-23', 'studyFirstSubmitDate': '2022-07-07', 'studyFirstSubmitQcDate': '2023-01-23', 'lastUpdatePostDateStruct': {'date': '2023-02-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-02-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Inventory of Functional Status after Childbirth', 'timeFrame': 'one time between 6-10 weeks postpartum', 'description': "Questionnaire used to measure a postpartum woman's ability to function within 5 different domains."}], 'secondaryOutcomes': [{'measure': 'Numeric Pain Scale', 'timeFrame': 'one time between 6-10 weeks postpartum', 'description': '0-10 scale for the participant to identify any areas of pain in various regions of the body'}, {'measure': 'Oswestry Low Back Pain Disability Index', 'timeFrame': 'one time between 6-10 weeks postpartum', 'description': 'A questionnaire to determine if the participant has any disability in the presence of low back pain'}, {'measure': 'Pelvic Floor Distress Index', 'timeFrame': 'one time between 6-10 weeks postpartum', 'description': 'Questionnaire to determine if the participant has pelvic floor dysfunction'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Overall Function'], 'conditions': ['Diastasis Recti']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': "Step 1: Recruitment\n\n* 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.\n* The recruitment fliers will ask interested women to email a student investigator to enroll in the research project.\n\nStep 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.\n\nStep 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).\n\nStep 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).\n\nStep 5: The data will be entered into SPSS and analyzed with appropriate statistical analyses."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '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.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Women ages 18-40 years\n* Postpartum (within 6-10 weeks of vaginal delivery)\n\nExclusion Criteria:\n\n* Women who are currently being treated by a physical therapist for their diastasis rectus abdominis\n* Women who had high-risk pregnancies (bedrest, gestational diabetes, pregnancy-induced hypertension)\n* Women with a history of abdominal or back surgery\n* Women with history of connective tissue disease such as Ehlers-Danlos Syndrome'}, 'identificationModule': {'nctId': 'NCT05709704', 'acronym': 'DRA', 'briefTitle': 'Comparison of Overall Function Between Postpartum Women With and Without Diastasis Rectus Abdominis', 'organization': {'class': 'OTHER', 'fullName': "Texas Woman's University"}, 'officialTitle': 'Comparison of Overall Function Between Postpartum Women With and Without Diastasis Rectus Abdominis', 'orgStudyIdInfo': {'id': 'IRB-FY2021-405'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Postpartum Women WITH DRA', 'description': 'Participants who have the diagnosis of diastasis rectus abdominis', 'interventionNames': ['Diagnostic Test: Self-palpation via telehealth', 'Diagnostic Test: Real-time Ultrasound']}, {'label': 'Postpartum Women WITHOUT DRA', 'description': 'Participants who do not have a diagnosis of diastasis rectus abdominis', 'interventionNames': ['Diagnostic Test: Self-palpation via telehealth', 'Diagnostic Test: Real-time Ultrasound']}], 'interventions': [{'name': 'Self-palpation via telehealth', 'type': 'DIAGNOSTIC_TEST', 'description': 'This will be used to determine if the participant has the diagnosis', 'armGroupLabels': ['Postpartum Women WITH DRA', 'Postpartum Women WITHOUT DRA']}, {'name': 'Real-time Ultrasound', 'type': 'DIAGNOSTIC_TEST', 'description': 'This will be used in a subgroup of participants to confirm/rule out a diagnosis', 'armGroupLabels': ['Postpartum Women WITH DRA', 'Postpartum Women WITHOUT DRA']}]}, 'contactsLocationsModule': {'locations': [{'zip': '67260', 'city': 'Wichita', 'state': 'Kansas', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Jennifer Celso, DPT', 'role': 'CONTACT', 'email': 'jennifer.celso@wichita.edu', 'phone': '316-978-5648'}, {'name': 'Jennifer Celso, DPT', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Brooke Schutte', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Amanda Goebel', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Shayna Karmann', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Sterling Pray', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Samantha Reif', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Shelby Davis', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Michaela Gerhard', 'role': 'SUB_INVESTIGATOR'}, {'name': "B'Aylana Morgan", 'role': 'SUB_INVESTIGATOR'}, {'name': 'Alexandria Rausch', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Haylie Schmidt', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Madelyn Hayes', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Madisyn Keller', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Peyton Price', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Ashley Zane', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Lauren Zwiesler', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Sharon Wang-Price, PhD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Wichita State University', 'geoPoint': {'lat': 37.69224, 'lon': -97.33754}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Texas Woman's University", 'class': 'OTHER'}, 'collaborators': [{'name': 'Wichita State University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}