Ignite Creation Date:
2025-12-25 @ 12:45 AM
Ignite Modification Date:
2025-12-25 @ 10:58 PM
Study NCT ID:
NCT04810767
Status:
UNKNOWN
Last Update Posted:
2021-09-21
First Post:
2021-03-21
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Chronic Pain After CS in Egypt
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D059350', 'term': 'Chronic Pain'}], 'ancestors': [{'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D011795', 'term': 'Surveys and Questionnaires'}], 'ancestors': [{'id': 'D003625', 'term': 'Data Collection'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D017531', 'term': 'Health Care Evaluation Mechanisms'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2023-05', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-09', 'completionDateStruct': {'date': '2024-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-09-20', 'studyFirstSubmitDate': '2021-03-21', 'studyFirstSubmitQcDate': '2021-03-22', 'lastUpdatePostDateStruct': {'date': '2021-09-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-03-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Chronic pain', 'timeFrame': 'Three months after the last ceserean section', 'description': 'Pain experienced assessed by questionnaire described by Nikolajsen et al, 2004'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Chronic Pain']}, 'descriptionModule': {'briefSummary': "This retrospective study will include Women who will attending to Azhar assuit, Sohag and South valley universities hospitals for any reason in the duration from 1 May to 31 October 2021, and who underwent elective CD under spinal anesthesia with horizontal lower abdominal surgical incision within last two years.\n\nExclusion criteria will be refusal to participate, age less than 18 years, recent CD (within 3 months), if the infant had died, and history of chronic pain medications or psychiatric disorder.\n\nData collection\n\nParticipants will be contacted personally by one of study authors. Data collected are consisted of:\n\n* Participants' characteristics as Age, parity and ways of delivery, weight, height, residency, husband smoking status, work, previous abdominal surgery, history of diabetes mellitus and hypertension.\n* Last CD related data which include presence of multiple pregnancies, if CD was in private/public facility, presence surgical wound infection.\n* Pain experienced will be assessed by questionnaire described by Nikolajsen et al, 2004"}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '20 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': '20-40 years old Women attending to Al Azhar assuit, Sohag and South valley universities hospitals for any reason in the duration from 1 May to 31 October 2021, and who underwent elective ceserean section under spinal anesthesia with horizontal lower abdominal surgical incision within last two years', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Women attending to Azhar assuit, Sohag and South valley universities hospitals for any reason in the duration from 1 May to 31 October 2021, and who underwent elective ceserean section under spinal anesthesia with horizontal lower abdominal surgical incision within last two years\n\nExclusion Criteria:\n\n* refusal to participate, age less than 18 years, recent ceserean section (within 3 months), if the infant had died, and history of chronic pain medications or psychiatric disorder'}, 'identificationModule': {'nctId': 'NCT04810767', 'briefTitle': 'Chronic Pain After CS in Egypt', 'organization': {'class': 'OTHER', 'fullName': 'Sohag University'}, 'officialTitle': 'Prevalence and Risk Factors for Chronic Pain After Cesarean Delivery in Upper Egypt: Retrospective Study', 'orgStudyIdInfo': {'id': '2020'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Questionnaire', 'type': 'OTHER', 'description': 'Pain experienced assessed by questionnaire described by Nikolajsen et al, 2004'}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Bahaa M Refaie, Lecturer', 'role': 'CONTACT', 'email': 'bahaarefaay@med.sohag.edu.eg', 'phone': '00201026887257'}, {'name': 'Mohammed A Soliman', 'role': 'CONTACT', 'email': 'Mohammedsoliman@med.svu.edu.eg'}], 'overallOfficials': [{'name': 'Kareem ElGebaly, Lecturer', 'role': 'STUDY_CHAIR', 'affiliation': 'Lecturer of anesthesia and ICU'}, {'name': 'Hossam Eldin Mostafa, Consultant', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Consultant of anesthesia and ICU Elhelal insurance hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bahaa Mohammed Refaie', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Lecturer of anesthesia and ICU', 'investigatorFullName': 'Bahaa Mohammed Refaie', 'investigatorAffiliation': 'Sohag University'}}}}