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Cash Benefits and Reproductive/Perinatal Health

Sponsor
Harvard Medical School (HMS and HSDM) (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT05782660
Collaborator
Brigham and Women's Hospital (Other)
3,615
Enrollment
1
Location
2
Arms
37.1
Anticipated Duration (Months)
97.4
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Cash Benefit
  • Other: No Cash Benefit
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
3615 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Cash Benefits and Reproductive/Perinatal Health
Actual Study Start Date :
Jul 27, 2020
Actual Primary Completion Date :
Dec 31, 2021
Anticipated Study Completion Date :
Aug 31, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Treatment Group

Participants in the treatment group received up to $400 per month.

Other: Cash Benefit
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.
Other Names:
  • Basic Income
  • Debit Card

    		•
    Active Comparator: Control Group

    Participants in the control group did not receive monthly cash benefits.

    Other: No Cash Benefit
    No monthly cash benefit.

    Outcome Measures

    Primary Outcome Measures

    1. Pregnancy [20 months]

      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

    Secondary Outcome Measures

    1. Miscarriage [20 months]

      Miscarriages presenting to the health care setting identified using diagnosis codes and documentation within clinical notes

    2. Abortion [20 months]

      Procedural abortions and prescriptions for medical abortions, focusing specifically on induced abortions

    3. Prenatal vitamin prescriptions prior to pregnancy [10 months]

      New use of prenatal vitamins, including multivitamins, as prescribed or documented in the electronic health record

    4. Contraception [10 months]

      Utilization of long-acting reversible contraceptive methods (intrauterine devices or implants) and prescriptions for hormonal birth control methods (pill, patch, ring)

    5. Number and timing of prenatal visits before delivery [20 months]

      Prenatal visits before delivery and initiation during first trimester

    6. Composite of birth outcomes [20 months]

      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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    15 Years to 44 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Resident of Chelsea, Massachusetts

    • Household income at or below 30% of the U.S. Department of Housing and Urban Development's Area Median Income

    • Childbearing age

    Exclusion Criteria:
    • See inclusion criteria

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Harvard Medical School Boston Massachusetts United States 02115

    Sponsors and Collaborators

    • Harvard Medical School (HMS and HSDM)
    • Brigham and Women's Hospital

    Investigators

    • Principal Investigator: Sumit D Agarwal, MD, MPH, Brigham and Women's Hospital and Harvard Medical School

    Study Documents (Full-Text)

    More Information

    Publications

    None provided.
    Responsible Party:
    Sumit Agarwal, Instructor, Harvard Medical School (HMS and HSDM)
    ClinicalTrials.gov Identifier:
    NCT05782660
    Other Study ID Numbers:
    • 2022P000093-2
    First Posted:
    Mar 23, 2023
    Last Update Posted:
    Mar 27, 2023
    Last Verified:
    Mar 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Abortion, Spontaneous

    Study Results

    No Results Posted as of Mar 27, 2023