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Active, Not Recruiting

NCT Number: NCT05782660

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Maternal Care Patterns Abortion, Spontaneous Female Urogenital Diseases and Pregnancy Complications Miscarriage Pregnancy Complications Pregnancy Related Urogenital Diseases

Age range

15 year–44 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Harvard Medical School

Boston, Massachusetts, 02115, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cash Benefit

Other

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

No Cash Benefit

Other

No monthly cash benefit.

Primary outcomes

  1. Pregnancy

    Time frame: 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 outcomes

  1. Miscarriage

    Time frame: 20 months

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

  2. Abortion

    Time frame: 20 months

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

  3. Prenatal vitamin prescriptions prior to pregnancy

    Time frame: 10 months

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

  4. Contraception

    Time frame: 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

    Time frame: 20 months

    Prenatal visits before delivery and initiation during first trimester

  6. Composite of birth outcomes

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Harvard Medical School (HMS and HSDM)

Other

Collaborators

  • Brigham and Women's Hospital

Registry information

Important dates

Study start
2020
Primary completion
2021
Study completion
2025
First posted
Mar 23, 2023
Registry last updated
Jul 12, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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