Ignite Creation Date:
2025-12-25 @ 4:08 AM
Ignite Modification Date:
2025-12-26 @ 3:05 AM
Study NCT ID:
NCT04632420
Status:
COMPLETED
Last Update Posted:
2023-04-11
First Post:
2020-10-30
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Evaluation of Headache and Childbirth in a Chronic Pain Population
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006261', 'term': 'Headache'}], 'ancestors': [{'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1112}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-09-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-04', 'completionDateStruct': {'date': '2020-02-26', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-04-10', 'studyFirstSubmitDate': '2020-10-30', 'studyFirstSubmitQcDate': '2020-11-11', 'lastUpdatePostDateStruct': {'date': '2023-04-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-11-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-02-26', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Prevalence of chronic headache', 'timeFrame': '10 minute questionnaire', 'description': 'Percentage of patients with chronic headache in women who have given birth and who have not given birth'}], 'secondaryOutcomes': [{'measure': 'Severity of headache', 'timeFrame': '10 minute questionnaire', 'description': '1 to 10 scale. 1 is almost no pain, 10 is worst pain imaginable'}, {'measure': 'Frequency of worst headache', 'timeFrame': '10 minute questionnaire', 'description': 'How many days per month did patients have worst headaches'}, {'measure': 'Age of onset of headache', 'timeFrame': '10 minute questionnaire', 'description': 'Age of onset of headache'}, {'measure': 'Postpartum headache', 'timeFrame': '10 minute questionnaire', 'description': 'Percentage of headache in the postpartum period in women who have given birth'}, {'measure': 'Predictors for postpartum headache', 'timeFrame': '10 minute questionnaire', 'description': 'Association between demographics/headache characteristics/predisposing risk factors and postpartum headache'}, {'measure': 'Risk factors for developing acute or acutely worsened headache within 5 days of delivery', 'timeFrame': '10 minute questionnaire', 'description': 'Association between demographic, obstetric or anesthesia related factors and acute or acutely worsened headache within 5 days of delivery'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Headache']}, 'descriptionModule': {'briefSummary': 'Headache and backache are common symptoms following childbirth. The incidence of these symptoms have been shown to increase during the postpartum period between 5 to 12 months following delivery. By 12 months postpartum up to 45% and 65% of women experience headache and backache, respectively. While studies have reported headache and backache as frequently persistent symptoms beyond the first year postpartum, few studies have specifically interrogated women seeking specialist pain physician input or identified predisposing risk factors. Finally there is little known about typically described pain characteristics of women who suffer with chronic postpartum headache and backache. We aim to compare the prevalence of chronic headache in women that have versus have not experienced childbirth.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Women who went to the pain clinic and fulfill the inclusion and exclusion criteria.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Women greater than 18 years old\n* Agreeing to be contacted for research purposes.\n* Able to read and understand English who have had agreed to be contacted with a valid email address\n\nExclusion Criteria:\n\n* Self identified as non-female\n* Age \\<18 years old.\n* Women without computer or electronic device access or valid email address and women who did not respond'}, 'identificationModule': {'nctId': 'NCT04632420', 'briefTitle': 'Evaluation of Headache and Childbirth in a Chronic Pain Population', 'organization': {'class': 'OTHER', 'fullName': 'Stanford University'}, 'officialTitle': 'Evaluation of Headache and Childbirth in a Chronic Pain Population', 'orgStudyIdInfo': {'id': '52732b'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Women with child birth', 'description': 'Women attending chronic pain clinic who have previously experienced childbirth'}, {'label': 'Women without childbirth', 'description': 'Women attending chronic pain clinic who have not previously experienced childbirth'}]}, 'contactsLocationsModule': {'locations': [{'zip': '94305', 'city': 'Stanford', 'state': 'California', 'country': 'United States', 'facility': 'Stanford University', 'geoPoint': {'lat': 37.42411, 'lon': -122.16608}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Stanford University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Pamela Flood', 'investigatorAffiliation': 'Stanford University'}}}}