Ignite Creation Date:
2025-12-24 @ 2:33 PM
Ignite Modification Date:
2025-12-25 @ 7:16 PM
Study NCT ID:
NCT05537259
Status:
COMPLETED
Last Update Posted:
2025-01-13
First Post:
2022-07-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
BUMPP: A Study to Better Understand Mood During the Perinatal Period
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000092862', 'term': 'Psychological Well-Being'}], 'ancestors': [{'id': 'D010549', 'term': 'Personal Satisfaction'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 168}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-06-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2024-02-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-01-09', 'studyFirstSubmitDate': '2022-07-06', 'studyFirstSubmitQcDate': '2022-09-11', 'lastUpdatePostDateStruct': {'date': '2025-01-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-09-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-11-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Self-report questionnaire measure of depressive symptoms (Edinburgh Postnatal Depression Scale)', 'timeFrame': '35 weeks of pregnancy through 2 months postpartum', 'description': 'Assessed at each of 4 sessions'}, {'measure': 'Self-report questionnaire measure of anxiety symptoms (Generalized Anxiety Disorder-7)', 'timeFrame': '35 weeks of pregnancy through 2 months postpartum', 'description': 'Assessed at each of 4 sessions'}, {'measure': 'Self-report questionnaire measure of manic symptoms (Highs Scale)', 'timeFrame': '35 weeks of pregnancy through 2 months postpartum', 'description': 'Assessed at each of 4 sessions'}, {'measure': 'Self-report questionnaire measure of symptoms of psychosis (subscales of Symptom Checklist-90)', 'timeFrame': '35 weeks of pregnancy through 2 months postpartum', 'description': 'Assessed at each of 4 sessions'}, {'measure': 'Mother-infant behavior during 5 min play episode coded using Global Rating Scales', 'timeFrame': '2 months postpartum', 'description': 'Assessed at in-person laboratory session (session 4)'}, {'measure': 'Bayley Scales of Infant Development, 4th edition, to assess infant cognitive development', 'timeFrame': '2 months postpartum', 'description': 'Assessed at in-person laboratory session (session 4)'}], 'secondaryOutcomes': [{'measure': 'Monthly cortisol levels determined from hair sample', 'timeFrame': '35 weeks of pregnancy through 2 months postpartum', 'description': '1 sample at session 4'}, {'measure': 'Cytokine levels determined from finger prick blood spot', 'timeFrame': '35 weeks of pregnancy through 2 months postpartum', 'description': '3 samples (sessions 1, 2, and 4)'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Pregnancy', 'Postpartum', 'Mental Health'], 'conditions': ['Pregnancy', 'Postpartum', 'Mental Health Issue']}, 'descriptionModule': {'briefSummary': 'The overall goal of the BUMPP study is to improve our understanding of a range of moods, feelings, and thoughts that women can experience during pregnancy and soon after they give birth. This study will examine how these moods, feelings, and thoughts are related to changes in hormonal and immune health that women experience during and after pregnancy, and to mother-baby relationships and infant development in the early postpartum months.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Pregnant women and their infants', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18 years or older\n* 35 weeks pregnant or less\n* carrying only one baby (not twins or triplets)\n* first time giving birth\n* can speak/read/write in English\n\nExclusion Criteria:\n\n* major medical health condition like a heart, kidney, or liver disease or HIV\n* currently taking corticosteroids, progesterone, or immunosuppressive medications that might impact the samples we are taking in this research study\n* have regularly used alcohol, tobacco, or recreational drugs (such as marijuana or prescription drugs for non-medical reasons) during pregnancy (regularly means more than a few times total, such as on a monthly, weekly, or daily basis)'}, 'identificationModule': {'nctId': 'NCT05537259', 'acronym': 'BUMPP', 'briefTitle': 'BUMPP: A Study to Better Understand Mood During the Perinatal Period', 'organization': {'class': 'OTHER', 'fullName': 'University of Minnesota'}, 'officialTitle': 'BUMPP: A Study to Better Understand Mood During the Perinatal Period', 'orgStudyIdInfo': {'id': 'CEHD-2023-31101'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Observation Group', 'description': 'Researchers will collect data on maternal mental health symptoms, as well as health and psychosocial factors, via short interviews (sessions 1 and 4) and via self-report questionnaires completed through REDCap at each session. Participating women will also provide one small hair sample (session 4) for measurement of the stress hormone cortisol and several finger stick blood spot samples (sessions 1,2, and 4) for measurement of immune markers.', 'interventionNames': ['Other: Observation Group']}], 'interventions': [{'name': 'Observation Group', 'type': 'OTHER', 'description': 'No intervention; this is an observational study.', 'armGroupLabels': ['Observation Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '55455', 'city': 'Minneapolis', 'state': 'Minnesota', 'country': 'United States', 'facility': 'University of Minnesota', 'geoPoint': {'lat': 44.97997, 'lon': -93.26384}}], 'overallOfficials': [{'name': 'Megan Gunnar, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Minnesota'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Minnesota', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}