Ignite Creation Date:
2025-12-24 @ 4:58 PM
Ignite Modification Date:
2025-12-25 @ 2:39 PM
Study NCT ID:
NCT03835650
Status:
COMPLETED
Last Update Posted:
2021-05-14
First Post:
2019-02-04
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Pelvic Girdle Pain Early Postpartum: Underlying Condition and Associated Factors
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D059388', 'term': 'Pelvic Girdle Pain'}, {'id': 'D046548', 'term': 'Pubic Symphysis Diastasis'}], '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'}, {'id': 'D000070631', 'term': 'Diastasis, Bone'}, {'id': 'D004204', 'term': 'Joint Dislocations'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D011644', 'term': 'Puerperal Disorders'}, {'id': 'D011248', 'term': 'Pregnancy Complications'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 105}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-05', 'completionDateStruct': {'date': '2021-02-25', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-05-11', 'studyFirstSubmitDate': '2019-02-04', 'studyFirstSubmitQcDate': '2019-02-07', 'lastUpdatePostDateStruct': {'date': '2021-05-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-02-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-02-25', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Diastasis Recti: ultrasound measurement of inter-recti distance', 'timeFrame': 'one time assessment, during the hospital stay, within 1st week postpartum', 'description': 'measurement of inter-recti distance (ultrasound assessment at the level of umbilicus, 2cm over the umbilicus and 2 cm below)'}, {'measure': 'Pubic symphysis distance', 'timeFrame': 'one time assessment, during the hospital stay, within 1st week postpartum', 'description': 'assesment of pubic symphysis distance - presence of diastasis pubic symphysis, distance measured by ultrasound'}], 'secondaryOutcomes': [{'measure': 'Pain Catastrophizing Scale', 'timeFrame': 'one time assessment, during the hospital stay, within 1st week postpartum', 'description': 'Assesment of Catastrophizing'}, {'measure': 'Epidural anaesthesia', 'timeFrame': 'during labour (Time form injection to full cervical dilatation)', 'description': 'Time form injection to full cervical dilatation'}, {'measure': 'Epidural anaesthaesia2', 'timeFrame': 'during labour (Time form injection to labour)', 'description': 'Time form injection to labour'}, {'measure': 'Diastasis Recti: inter-recti distance', 'timeFrame': 'one time assessment, during the hospital stay, within 1st week postpartum', 'description': 'measurement of inter-recti distance by palpation examination at the level of umbilicus, 2cm over the umbilicus and 2 cm below'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Pelvic Girdle Pain', 'Pubic Symphysis Diastasis', 'Diastasis Recti']}, 'descriptionModule': {'briefSummary': "Background: Pregnancy-related pelvic girdle pain (PGP) can appear during pregnancy, directly after labour or can be delayed to 3 weeks postpartum. Pain is experienced between the posterior iliac crest and the gluteal fold, particularly in the vicinity of the Sacroiliac joints (SIJ). The pain may radiate in the posterior thigh and can also occur in conjunction with/or separately in the symphysis. The endurance capacity for standing, walking, and sitting is diminished. The diagnosis of PGP can be reached after exclusion of lumbar causes. The pain or functional disturbances in relation to PGP must be reproducible by specific clinical tests. Lack of accurate and early diagnosis of the PGP reasons postpartum may contribute to development of chronic condition, lowering quality of life years after delivery.\n\nObjectives: The aim of the project is to evaluate the underlying cause of the severe pelvic girdle pain postpartum (whether it is real PGP or diastasis pubic symphysis) and to assess the differences between females with severe postpartum PGP, mild and moderate PGP and with no PGP in terms of: presence of diastasis pubic symphysis, presence of diastasis recti and linea alba dysfunction, factors associated with labour and maladaptive mental processing (catastrophizing).\n\nMaterials and methods: Because of low incidence of researched conditions, a case control study will be the study design of choice. The subjects with PGP will be matched with those with no PGP. Subjects' assessment will consist of palpation and ultrasonography evaluation of diastasis recti(inter-recti distance), ultrasonography assesment of pubic symphysis (inter-pubic width) and mental processing (catastrophizing assessed with Pain Catastrophizing Scale) analysis. Factors connected with labour (time from epidural anaesthesia injection to full dilatation and delivery) will be also investigated.\n\nExpected results: To the investigators' knowledge, postpartum pelvic girdle pain has not been extensively studied so far. The study will bring information about the possible underlying cause of postpartum PGP: whether it is PGP or diastasis pubic symphysis."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Women in early postpartum period (during hospital stay)', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Natural labour or vacuum extractor or forceps\n* for the study group - pain due to PGP confirmed with dedicated functional tests\n* for control group with no pain - no pain due to PGP\n* agreement to participate\n\nExclusion Criteria:\n\n* diseases that can mimic PGP f.ex. Scheuermann disease, rheumatoid arthritis, Ehler's-Danlos Syndrome, hip dysplasia\n* major peri-partum events like internal haemorrhage, pelvic fracture"}, 'identificationModule': {'nctId': 'NCT03835650', 'briefTitle': 'Pelvic Girdle Pain Early Postpartum: Underlying Condition and Associated Factors', 'organization': {'class': 'OTHER', 'fullName': 'Żelazna Medical Centre, LLC'}, 'officialTitle': 'Pelvic Girdle Pain Early Postpartum: Underlying Condition and Associated Factors', 'orgStudyIdInfo': {'id': 'PN/19/2019'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'PGP', 'description': 'Patients in early postpartum period experiencing PGP, confirmed with dedicated functional tests'}, {'label': 'no PGP', 'description': 'Patients in early postpartum period, with no symptoms and signs of PGP'}]}, 'contactsLocationsModule': {'locations': [{'zip': '01-004', 'city': 'Warsaw', 'state': 'Masovian Voivodeship', 'country': 'Poland', 'facility': 'Centre of Postgraduate Medical Education', 'geoPoint': {'lat': 52.22977, 'lon': 21.01178}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Żelazna Medical Centre, LLC', 'class': 'OTHER'}, 'collaborators': [{'name': 'Centre of Postgraduate Medical Education', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}