Ignite Creation Date:
2025-12-25 @ 2:16 AM
Ignite Modification Date:
2025-12-27 @ 1:46 PM
Study NCT ID:
NCT05782660
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-07-12
First Post:
2023-03-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Cash Benefits and Reproductive/Perinatal Health
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000022', 'term': 'Abortion, Spontaneous'}], 'ancestors': [{'id': 'D011248', 'term': 'Pregnancy Complications'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2023-03-23', 'size': 144523, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2023-03-23T05:50', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 3615}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2020-07-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-07', 'completionDateStruct': {'date': '2025-08-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-07-11', 'studyFirstSubmitDate': '2023-03-11', 'studyFirstSubmitQcDate': '2023-03-11', 'lastUpdatePostDateStruct': {'date': '2024-07-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-03-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pregnancy', 'timeFrame': '20 months', 'description': 'Pregnancies will be identified using the electronic health record, documented with a positive urine or blood pregnancy test, ultrasound, and/or diagnosis codes over the 10 months of the trial; because pregnancy without delivery is the primary outcome for our main analysis, the investigators will then determine whether each pregnancy did or did not result in a live childbirth delivered vaginally or via Cesarean section, which can occur after the 10 months of the trial'}], 'secondaryOutcomes': [{'measure': 'Miscarriage', 'timeFrame': '20 months', 'description': 'Miscarriages presenting to the health care setting identified using diagnosis codes and documentation within clinical notes'}, {'measure': 'Abortion', 'timeFrame': '20 months', 'description': 'Procedural abortions and prescriptions for medical abortions, focusing specifically on induced abortions'}, {'measure': 'Prenatal vitamin prescriptions prior to pregnancy', 'timeFrame': '10 months', 'description': 'New use of prenatal vitamins, including multivitamins, as prescribed or documented in the electronic health record'}, {'measure': 'Contraception', 'timeFrame': '10 months', 'description': 'Utilization of long-acting reversible contraceptive methods (intrauterine devices or implants) and prescriptions for hormonal birth control methods (pill, patch, ring)'}, {'measure': 'Number and timing of prenatal visits before delivery', 'timeFrame': '20 months', 'description': 'Prenatal visits before delivery and initiation during first trimester'}, {'measure': 'Composite of birth outcomes', 'timeFrame': '20 months', 'description': 'Following McConnell et al., this outcome is a composite of at least one of: low birth weight, preterm birth, small for gestational age, or perinatal mortality'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Maternal Care Patterns', 'Pregnancy Related', 'Miscarriage']}, 'descriptionModule': {'briefSummary': 'During the first two years of the COVID-19 pandemic, the City of Chelsea, Massachusetts held a lottery to allocate cash benefits to its residents for ten months. Using data from the Chelsea Eats program, the investigators propose to study the impact of the cash benefit on reproductive and perinatal health.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '44 Years', 'minimumAge': '15 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Resident of Chelsea, Massachusetts\n* Household income at or below 30% of the U.S. Department of Housing and Urban Development's Area Median Income\n* Childbearing age\n\nExclusion Criteria:\n\n* See inclusion criteria"}, 'identificationModule': {'nctId': 'NCT05782660', 'briefTitle': 'Cash Benefits and Reproductive/Perinatal Health', 'organization': {'class': 'OTHER', 'fullName': 'Harvard Medical School (HMS and HSDM)'}, 'officialTitle': 'Cash Benefits and Reproductive/Perinatal Health', 'orgStudyIdInfo': {'id': '2022P000093-2'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treatment Group', 'description': 'Participants in the treatment group received up to $400 per month.', 'interventionNames': ['Other: Cash Benefit']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control Group', 'description': 'Participants in the control group did not receive monthly cash benefits.', 'interventionNames': ['Other: No Cash Benefit']}], 'interventions': [{'name': 'Cash Benefit', 'type': 'OTHER', 'otherNames': ['Basic Income', 'Debit Card'], 'description': 'Spending from the cards was not restricted to food but could be spent on anything and anywhere Visa was accepted. The debit cards were credited with the first payment on November 18th, 2020 and the second payment on December 18th, 2020. The program continued with monthly credits through August 2021.', 'armGroupLabels': ['Treatment Group']}, {'name': 'No Cash Benefit', 'type': 'OTHER', 'description': 'No monthly cash benefit.', 'armGroupLabels': ['Control Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02115', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Harvard Medical School', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}], 'overallOfficials': [{'name': 'Sumit D Agarwal, MD, MPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Brigham and Women's Hospital and Harvard Medical School"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Harvard Medical School (HMS and HSDM)', 'class': 'OTHER'}, 'collaborators': [{'name': "Brigham and Women's Hospital", 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Instructor', 'investigatorFullName': 'Sumit Agarwal', 'investigatorAffiliation': 'Harvard Medical School (HMS and HSDM)'}}}}