Cash Benefits and Reproductive/Perinatal Health

Pregnancy Related Clinical Trial

Official title:

Cash Benefits and Reproductive/Perinatal Health

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05782660
• Other study ID #: 2022P000093-2
• Status: Active, not recruiting
• Phase: N/A
• Start date: July 27, 2020
• Est. completion date: August 31, 2023

Study information

• Verified date: March 2023
• Source: Harvard Medical School (HMS and HSDM)
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 3615
• Est. completion date: August 31, 2023
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 15 Years to 44 Years

Eligibility

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

Related Conditions & MeSH terms

• Abortion, Spontaneous
• Maternal Care Patterns
• Miscarriage
• Pregnancy Related

Intervention

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.
• No Cash Benefit
No monthly cash benefit.

Locations

Country	Name	City	State
United States	Harvard Medical School	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Harvard Medical School (HMS and HSDM)	Brigham and Women's Hospital

Country where clinical trial is conducted

United States, 

Outcome

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