Ignite Creation Date:
2025-12-24 @ 5:43 PM
Ignite Modification Date:
2025-12-25 @ 8:55 PM
Study NCT ID:
NCT07037368
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-06-25
First Post:
2025-06-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Impact of Delivery Mode on Coccydynia, Pelvic Girdle Pain and Rectus Diastasis in Postpartum Females
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D059388', 'term': 'Pelvic Girdle Pain'}], 'ancestors': [{'id': 'D059352', 'term': 'Musculoskeletal Pain'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D017699', 'term': 'Pelvic Pain'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 73}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2025-03-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2025-09-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-06-17', 'studyFirstSubmitDate': '2025-06-17', 'studyFirstSubmitQcDate': '2025-06-17', 'lastUpdatePostDateStruct': {'date': '2025-06-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-06-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-06-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Visual Analog Scale', 'timeFrame': '6 Month', 'description': 'A 10 cm horizontal line marked from 0 (no pain) to 10 (worst imaginable pain). Scoring: The participant marks a point on the line that best represents their pain intensity. The score is measured in centimeters from the "no pain" end. Higher scores indicate more severe pain.'}, {'measure': 'Pelvic Girdle Questionnaire (PGQ)', 'timeFrame': '6 Months', 'description': 'Contains 25 items divided into two domains: activity limitations (20 items) and symptoms (5 items).\n\nScoring: Each item is rated on a 4-point scale (0 = not at all, 1 = to a small extent, 2 = to some extent, 3 = to a great extent). Scores are summed, converted into a percentage of the maximum possible score. Higher percentages reflect greater pelvic girdle pain and disability.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Pelvic Girdle Pain', 'Rectus Diastasis']}, 'descriptionModule': {'briefSummary': 'This comparative observational study investigates the impact of delivery mode vaginal delivery versus cesarean section on the prevalence and severity of three postpartum musculoskeletal complications: coccydynia, pelvic girdle pain (PGP), and rectus diastasis (RD). Conducted on postpartum females aged 20-40 years within 6 weeks to 6 months after childbirth, the study aims to highlight musculoskeletal outcomes often overlooked in standard postpartum care.', 'detailedDescription': 'A total of 73 participants were selected through non-probability sampling from rehabilitation centers and home-based postpartum populations in Lahore. Pain intensity and musculoskeletal impairments were assessed using validated tools: the Visual Analog Scale (VAS) for coccydynia, Pelvic Girdle Questionnaire (PGQ) for PGP, and finger-width palpation technique for RD. The data collection involved both self-reported questionnaires and clinical assessments by trained professionals. The goal is to identify how delivery mode influences musculoskeletal health and to support the development of more tailored physiotherapy interventions and postpartum care strategies.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '20 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'This comparative observational study investigates the impact of delivery mode vaginal delivery versus cesarean section on the prevalence and severity of three postpartum musculoskeletal complications: coccydynia, pelvic girdle pain (PGP), and rectus diastasis (RD).', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Postpartum females aged 20-40 years\n* Females who delivered via vaginal delivery or cesarean section\n* 6 weeks to 6 months postpartum period\n* Willingness to participate and provide informed consent\n\nExclusion Criteria:\n\n* Females with a history of pelvic or spinal surgery prior to pregnancy\n* Known cases of pre-existing musculoskeletal disorders (e.g., scoliosis, chronic back pain)\n* Multiple pregnancies (twins or more) in the current or previous delivery\n* Postpartum complications unrelated to delivery mode (e.g., sepsis, trauma)'}, 'identificationModule': {'nctId': 'NCT07037368', 'briefTitle': 'Impact of Delivery Mode on Coccydynia, Pelvic Girdle Pain and Rectus Diastasis in Postpartum Females', 'organization': {'class': 'OTHER', 'fullName': 'Superior University'}, 'officialTitle': 'Impact of Delivery Mode on Coccydynia, Pelvic Girdle Pain and Rectus Diastasis in Postpartum Females: a Comparative Study', 'orgStudyIdInfo': {'id': 'DPT/Batch-Fall20/1015'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Impact of Delivery Mode', 'interventionNames': ['Behavioral: Impact of Delivery Mode']}], 'interventions': [{'name': 'Impact of Delivery Mode', 'type': 'BEHAVIORAL', 'description': 'investigates the impact of delivery mode vaginal delivery versus cesarean section on the prevalence and severity of three postpartum musculoskeletal complications: coccydynia, pelvic girdle pain (PGP), and rectus diastasis (RD). Conducted on postpartum females', 'armGroupLabels': ['Impact of Delivery Mode']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Lahore', 'state': 'Punjab Province', 'country': 'Pakistan', 'facility': 'Superior University CRC', 'geoPoint': {'lat': 31.558, 'lon': 74.35071}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Superior University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Muhammad Naveed Babur', 'investigatorAffiliation': 'Superior University'}}}}