Cash Benefits and Reproductive/Perinatal Health

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Pregnancy Related; Miscarriage; Maternal Care Patterns
• Intervention / Treatment: Other: Cash Benefit; Other: No Cash Benefit

• Study Type: Interventional
• Enrollment (Estimated): 3615
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Harvard Medical School

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 15 years to 44 years (Child, Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pregnancy	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	20 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Miscarriage	Miscarriages presenting to the health care setting identified using diagnosis codes and documentation within clinical notes	20 months
Abortion	Procedural abortions and prescriptions for medical abortions, focusing specifically on induced abortions	20 months
Prenatal vitamin prescriptions prior to pregnancy	New use of prenatal vitamins, including multivitamins, as prescribed or documented in the electronic health record	10 months
Contraception	Utilization of long-acting reversible contraceptive methods (intrauterine devices or implants) and prescriptions for hormonal birth control methods (pill, patch, ring)	10 months
Number and timing of prenatal visits before delivery	Prenatal visits before delivery and initiation during first trimester	20 months
Composite of birth outcomes	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	20 months

Collaborators and Investigators

• Sponsor: Harvard Medical School (HMS and HSDM)
• Collaborators: Brigham and Women's Hospital
• Investigators: Principal Investigator: Sumit D Agarwal, MD, MPH, Brigham and Women's Hospital and Harvard Medical School

Study record dates

Study Major Dates

• Study Start (Actual): July 27, 2020
• Primary Completion (Actual): December 31, 2021
• Study Completion (Estimated): August 31, 2025

Study Registration Dates

• First Submitted: March 11, 2023
• First Submitted That Met QC Criteria: March 11, 2023
• First Posted (Actual): March 23, 2023

Study Record Updates

• Last Update Posted (Actual): July 12, 2024
• Last Update Submitted That Met QC Criteria: July 11, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Abortion, Spontaneous
• Other Study ID Numbers: 2022P000093-2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No