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Cash Benefits and Reproductive/Perinatal Health

Primary Purpose

Maternal Care Patterns, Pregnancy Related, Miscarriage

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Cash Benefit
No Cash Benefit
Sponsored by
Harvard Medical School (HMS and HSDM)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Maternal Care Patterns

Eligibility Criteria

15 Years - 44 Years (Child, Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Harvard Medical School

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Treatment Group

Control Group

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
March 11, 2023
Last Updated
March 23, 2023
Sponsor
Harvard Medical School (HMS and HSDM)
Collaborators
Brigham and Women's Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05782660
Brief Title
Cash Benefits and Reproductive/Perinatal Health
Official Title
Cash Benefits and Reproductive/Perinatal Health
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
July 27, 2020 (Actual)
Primary Completion Date
December 31, 2021 (Actual)
Study Completion Date
August 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Harvard Medical School (HMS and HSDM)
Collaborators
Brigham and Women's Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Maternal Care Patterns, Pregnancy Related, Miscarriage

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
3615 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Treatment Group
Arm Type
Experimental
Arm Description
Participants in the treatment group received up to $400 per month.
Arm Title
Control Group
Arm Type
Active Comparator
Arm Description
Participants in the control group did not receive monthly cash benefits.
Intervention Type
Other
Intervention Name(s)
Cash Benefit
Other Intervention Name(s)
Basic Income, Debit Card
Intervention 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.
Intervention Type
Other
Intervention Name(s)
No Cash Benefit
Intervention Description
No monthly cash benefit.
Primary Outcome Measure Information:
Title
Pregnancy
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
Time Frame
20 months
Secondary Outcome Measure Information:
Title
Miscarriage
Description
Miscarriages presenting to the health care setting identified using diagnosis codes and documentation within clinical notes
Time Frame
20 months
Title
Abortion
Description
Procedural abortions and prescriptions for medical abortions, focusing specifically on induced abortions
Time Frame
20 months
Title
Prenatal vitamin prescriptions prior to pregnancy
Description
New use of prenatal vitamins, including multivitamins, as prescribed or documented in the electronic health record
Time Frame
10 months
Title
Contraception
Description
Utilization of long-acting reversible contraceptive methods (intrauterine devices or implants) and prescriptions for hormonal birth control methods (pill, patch, ring)
Time Frame
10 months
Title
Number and timing of prenatal visits before delivery
Description
Prenatal visits before delivery and initiation during first trimester
Time Frame
20 months
Title
Composite of birth outcomes
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
Time Frame
20 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
44 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sumit D Agarwal, MD, MPH
Organizational Affiliation
Brigham and Women's Hospital and Harvard Medical School
Official's Role
Principal Investigator
Facility Information:
Facility Name
Harvard Medical School
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Cash Benefits and Reproductive/Perinatal Health

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