Moms and Babies Health and Well-being (NCT06923371) | Clinical Trial Compass
RecruitingNot Applicable
Moms and Babies Health and Well-being
United States1,250 participantsStarted 2025-02-28
Plain-language summary
The goal of this clinical trial is to see how giving direct cash support affects the health of pregnant women and their babies in the U.S. Many families, especially those with low incomes, face challenges during pregnancy and after childbirth. This study will explore whether financial help during these times leads to better health.
The main questions this research aims to answer are:
* Does extra money during pregnancy and a baby's first months improve the baby's growth and overall health?
* How does financial support affect a mother's physical and mental health before and after birth?
* Does having extra money help moms get better healthcare and make healthier food choices for themselves and their babies?
Participants in this study will be randomly assigned to either a high cash or low cash group. They will be enrolled in the study and asked to complete:
* A baseline survey
* A follow-up survey 12 months after enrollment
* A final survey 18 months after enrollment
In addition, participants' medical records will be reviewed, and some may be selected for a qualitative interview to share more about their experiences.
This research is being done in partnership with The Bridge Project, a program that helps moms in need. The goal is to find better ways to support the health of moms and babies facing financial hardship.
Who can participate
Age range
18 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria for treatment and control
* Living in any of the study sites: Appalachian regions (West Virginia, Ohio, Kentucky, Tennessee)
* Being in the first or second trimester
* Being 18 years or older
Exclusion criteria
* Mothers with severe conditions such as terminal cancer.
* Mothers with identified addiction disorders. This includes any current or past addiction to legal (pain medication, alcohol) or illegal substance that has known risk for self-harm death (suicide, overdose) and/or consequences for maternal and/or fetal health.
* Mothers younger than 18 years old.
* Not living in the study site range
* Mothers incarcerated during the course of the study
* Mothers institutionalized during the course of the study.
Additional Notes:
* Participants who are not eligible for this study are also excluded from enrolling in the Bridge Project and receiving the direct cash transfer.
* Per protocol, participation in the study will be determined based on the inclusion and exclusion criteria. Final eligibility and study participation decisions will be made at the discretion of the Principal Investigator.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Number of Preterm Babies
Timeframe: Immediately after birth
2
Number of babies with low birth weight
Timeframe: Immediately after birth
3
Score on Edinburgh Postnatal Depression Scale (EPDS) - Mothers Mental Health