Research study · now enrolling
Help us build the future of fetal monitoring
We are looking for people in their second or third trimester of pregnancy to take part in a voluntary, IRB-reviewed feasibility study of a new investigational wearable fetal monitoring device.
This is a research study, not a clinical service
The device is investigational and has not been approved by the US Food and Drug Administration. All data it collects is for research only and will not be used to make decisions about your clinical care. Taking part does not replace your regular prenatal care – please continue all scheduled appointments with your provider.
Take part
Register your interest
Registering is not consent and does not enrol you. The risks, eligibility and your rights are set out below, and in full in the consent form (which will be emailed to you prior to enrolment). You can stop at any point.
Changed your mind before enrolling? Email privacy@project-stardust.org and we will delete your address. You do not need to give a reason. If we do not hear from you, we delete it within 90 days.
About the study
What are we studying?
Project Stardust is collecting research data during pregnancy to train and validate machine learning models for fetal monitoring. Participants wear a new investigational wearable fetal monitoring device containing microphones, motion sensors and other passive sensors that record signals related to fetal development and wellbeing. During each session a separate ultrasound device is used by research staff to capture images of the fetus and provide ground-truth reference data.
The goal is to build high-quality paired datasets that let us develop algorithms capable of extracting meaningful signals from the non-ultrasound sensors alone. The long-term aim is an affordable, easy-to-use device for continuous fetal monitoring at home, for the many families who currently receive little or no monitoring between clinical visits.
As well as data from the device, the study collects information from your electronic medical records to understand your medical history and your clinicians’ assessments, and information about your newborn after delivery, which may require signing a medical release form. During sessions staff also record your own heart rate and blood pressure. This study does not provide clinical diagnoses or medical advice to participants.
Eligibility
Who can take part?
- You are 18 years of age or older
- You are 14 or more weeks pregnant – second or third trimester
- You are carrying a singleton pregnancy, that is one baby
- You do not have an implanted electronic device such as a pacemaker
- You can read and understand English
Both low-risk and high-risk pregnancies are eligible. The study team will confirm your eligibility before enrollment – there is nothing to work out on your own.
Study type
Non-therapeutic feasibility
Time commitment
Up to two hours a week, for 90–180 days
Location
In person in the Bay Area, New York or Boston – at our office or your home
Compensation
Up to $20 per session
Taking part
What does it involve?
Registering, consent, then eligibility
You give us an email address. The study team creates your record in the study system, which emails you the consent form to read and sign. Only after that are you asked the eligibility questions. Nothing below begins until all of it is done.
Weekly session, at home or in-office
Each week a study team member comes to your home, or you can come to our office, for a session of up to 2 hours where the device is worn to collect data. Sessions run in the Bay Area, New York and Boston.
Ultrasound data collection
During each session research staff use an ultrasound device to collect fetal signal data, as well as your own heart rate and blood pressure. These are research-only sessions: staff do not provide clinical readings, diagnoses or medical feedback.
Weekly questionnaire and diary
Around five minutes a week of questions about pregnancy-related concerns, plus a simple diary recording any symptoms, interruptions to wearing the device, contacts with your obstetric provider, and your baby’s movements.
What we ask of you. Continue all your regular prenatal care throughout the study – the device does not replace your standard prenatal visits. Tell study staff about any skin irritation or discomfort, and about any changes in your pregnancy, new medications or hospital stays. Return the device and all study materials at the end of your participation.
Any questions about your baby’s health should go to your own healthcare provider. Study staff do not give readings, diagnoses or medical feedback, so nothing from these sessions is provided to you or your provider as clinical information. Full details of all study activities will be explained before you decide, and you will have the opportunity to ask questions and give formal informed consent before anything begins.
Risks & benefits
What are the risks and benefits?
Ultrasound exposure. During each session research staff use a reference ultrasound device. Short-term ultrasound as used in standard prenatal care has a well-established safety record, but repeated use over an extended period during pregnancy has not been fully studied, and the long-term safety of this exposure pattern is not yet known. We do not believe it poses a significant risk based on current knowledge, but we cannot completely exclude the possibility of unforeseen effects. You should discuss any concerns with your obstetric provider before deciding to take part. The wearable device itself uses only microphones and motion sensors – no X-rays or other forms of radiation.
Risks that are not yet known. This study involves a new device and a new pattern of use. As with any investigational technology, there may be risks to you, your pregnancy or your baby that are not currently known.
The other known risks are expected to be mild. They include:
- Skin irritation, redness, itching or pressure-related discomfort where the device touches your skin. Expected to be mild and to resolve when the device is removed; staff check your skin at every visit.
- Discomfort from wearing the belt, particularly as your abdomen grows. The belt is adjustable and can be removed.
- A small risk of a data breach, as with any electronic health information.
- Some questionnaires may be upsetting. You do not have to answer any question you are not comfortable with.
Inconveniences. Study visits are separate from your regularly scheduled prenatal appointments, so they mean additional trips. Each weekly visit takes up to two hours, and keeping the diary adds a little time between visits.
Direct medical benefit. You are not expected to receive any direct medical benefit from this study. Your participation may contribute to fetal monitoring technology that helps future pregnancies.
Compensation. You will be compensated up to $20 per session. Taking part is entirely voluntary.
Privacy
How is your data protected?
- The email address you register with is held separately from all research data, in Google Workspace under a Business Associate Agreement, and is used only to create your record in the study system. If you are not enrolled it is deleted within 90 days – see our Consumer Health Data Privacy Policy
- Your name and contact information are stored separately from research data using a coded identifier
- Research data is stored on secure, encrypted servers, with access limited to authorized study personnel
- Published results will not include any information that could identify you
- If you withdraw, no new information will be collected from you. Information already collected stays part of the study database and cannot be removed, as required by the Food and Drug Administration
- Records may be shared with the research team, your health care team for treatment purposes, regulators such as the FDA and the Office for Human Research Protections, the sponsor Project Stardust, and collaborating hospitals or academic centres
- Every effort is made to protect your information, but absolute confidentiality cannot be guaranteed
Your rights
Taking part is completely voluntary
You may choose not to take part, and you may withdraw at any time, for any reason, with no penalty and no effect on your healthcare. You do not have to explain your decision.
The study investigator or sponsor may also withdraw you from the study without your consent – for example if continuing would be harmful to you, if you need treatment the study does not allow, or if the study is stopped. You will be told of any important new information learned during the study that might affect your health or your willingness to continue.
Details of who to contact about your rights as a research participant – including the independent review board that reviewed this study – are set out in the consent form you will go through before taking part. You do not have to decide anything before then.
The US Department of Health and Human Services publishes independent guidance for volunteers, including questions worth asking any research team: About Research Participation . It is offered for information only and does not imply any endorsement of this study or of Project Stardust.
Contact
Questions?
Privacy and data requests
To access, correct or delete the email address you registered with.
Already taking part?
If you have a medical problem, a research-related injury, or a question or complaint about the study, contact the study investigator using the telephone number on the first page of your consent form. If you need emergency care, tell the treating clinician you are taking part in a research study.