Maternal Care PatternsNCT05782660
Cash Benefits and Reproductive/Perinatal Health
A study testing Cash Benefit and No Cash Benefit in people with Maternal Care Patterns and Pregnancy Related, run by Harvard Medical School (HMS and HSDM) at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 15 to 44 years, women only
- Conditions the study is for
- Maternal Care Patterns, Pregnancy Related, Miscarriage
- What is being tested?
- Cash Benefit and No Cash Benefit
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3,615 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Jul 2020to 31 Aug 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 44 years
- Women only
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- See inclusion criteria
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Maternal Care Patterns, Pregnancy Related, Miscarriage
- Being tested
- Cash Benefit, No Cash Benefit
- Medical subject headings
- Abortion, Spontaneous
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cash BenefitOther
Also called Basic Income, Debit Card
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 BenefitOther
No monthly cash benefit.
| Study group | Role | What they receive |
|---|---|---|
| Treatment Group | Experimental | Participants in the treatment group received up to $400 per month. Receives: Other: Cash Benefit |
| Control Group | Active comparator | Participants in the control group did not receive monthly cash benefits. Receives: Other: No Cash Benefit |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 20 months
Secondary outcomes (6)
Miscarriage
Miscarriages presenting to the health care setting identified using diagnosis codes and documentation within clinical notes
Measured: 20 months
Abortion
Procedural abortions and prescriptions for medical abortions, focusing specifically on induced abortions
Measured: 20 months
Prenatal vitamin prescriptions prior to pregnancy
New use of prenatal vitamins, including multivitamins, as prescribed or documented in the electronic health record
Measured: 10 months
Contraception
Utilization of long-acting reversible contraceptive methods (intrauterine devices or implants) and prescriptions for hormonal birth control methods (pill, patch, ring)
Measured: 10 months
Number and timing of prenatal visits before delivery
Prenatal visits before delivery and initiation during first trimester
Measured: 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
Measured: 20 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2023
- Study start27 Jul 2020
- Primary completion31 Dec 2021
- Study completion31 Aug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Maternal Care PatternsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 3,615 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Harvard Medical School (HMS and HSDM)
- Sponsor type
- University, hospital or other
- Collaborators
- Brigham and Women's Hospital
- Responsible party
- Principal investigator, Sumit Agarwal, Harvard Medical School (HMS and HSDM)
- Investigators
- Sumit D Agarwal, MD, MPH, Principal investigator, Brigham and Women's Hospital and Harvard Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05782660
- Sponsor's protocol ID
- 2022P000093-2
- Status last verified
- Jul 2024
- First submitted
- 11 Mar 2023
- Last updated
- 12 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cash Benefits and Reproductive/Perinatal Health
- ClinicalTrials.gov ID
- NCT05782660
- Acronym / sponsor ID
- 2022P000093-2
- Conditions
- Maternal Care Patterns, Pregnancy Related, Miscarriage
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 3,615 participants (estimated)
- Lead sponsor
- Harvard Medical School (HMS and HSDM)University, hospital or other
- Collaborators
- Brigham and Women's Hospital
- Study start
- 27 Jul 2020 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 31 Aug 2025 (estimated)
- First posted
- 23 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment Group | Experimental | Other: Cash BenefitParticipants in the treatment group received up to $400 per month. |
| Control Group | Active comparator | Other: No Cash BenefitParticipants in the control group did not receive monthly cash benefits. |
Who may qualify
- Ages
- 15 to 44 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- See inclusion criteria
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cash BenefitAlso: Basic Income, Debit CardSpending 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 | Treatment Group |
| No Cash BenefitNo monthly cash benefit. | Other | Control Group |
Primary outcome
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
6 secondary outcomes
Miscarriage
Time frame: 20 months
Abortion
Time frame: 20 months
Prenatal vitamin prescriptions prior to pregnancy
Time frame: 10 months
Contraception
Time frame: 10 months
Number and timing of prenatal visits before delivery
Time frame: 20 months
Composite of birth outcomes
Time frame: 20 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jul 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sumit D Agarwal, MD, MPH principal investigator
Brigham and Women's Hospital and Harvard Medical School
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cash Benefit and No Cash Benefit in people with Maternal Care Patterns and Pregnancy Related, run by Harvard Medical School (HMS and HSDM) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pregnancy (time frame: 20 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jul 2024.