What is the goal of this study?

This study, called the BUMP study (Better Understanding the Metamorphosis of Pregnancy), hopes to detect and track pregnancy and conception symptoms. There are many things we still do not know about these experiences that can affect the health of mothers and babies.

The BUMP study plans to utilize smartphones and wearable devices to address those gaps in knowledge. This approach allows for more frequent data collection than what is captured at your traditional clinic visits.

The goal is to develop ways to follow symptoms such as fatigue, shortness of breath, or mood so, in the future, expecting mothers are able to act on these changes directly - by themselves and for themselves. This approach has the potential to eventually benefit women and families globally, including those from diverse backgrounds who lack access to care.

Your contributions to this study may have a valuable impact on future families. To learn more about the study, please visit 4YouandMe.org/bump2info or the study description at clinicaltrials.gov.

What will I be required to do if I choose to participate?

If you choose to participate you will be asked to complete the following tasks:

  • Use the Bodyport smart scale once per day
  • Wear your Oura Ring and Garmin Smart Watch every day
  • Complete in-app surveys daily (approximately 5 minutes per day)
  • Have a phone check-in with your study coordinator every 2-4 weeks

How long is study participation?

We will follow you until 3 months after delivery.

What compensation will I receive for participating?

You will obtain points for completing tasks. The points are then exchanged for compensation.You have an opportunity to earn up to $25 for each month of participation. If you complete the study you will also be able to keep your Oura Ring and Garmin Watch.

Are any in-person study visits required?

No! This study has no in-person visits so that you can make a difference right where you are. You will have phone check-ins with your study coordinator every 2-4 weeks for the duration of your participation in the study.

What is a phone check-in?

Every participant has a study coordinator to help you throughout the study. A check-in is a phone call with your study coordinator, every 2-4 weeks, to answer any questions you may have and complete a few study surveys. Your study coordinator will be your point of contact for the study and is there to support you on this journey.

What if I am over 16 weeks?

The study is only open to those who are less than 16 weeks pregnant. This includes women who are currently in their 15th week of pregnancy and below.

Is there any medical or pregnancy-specific history that makes me not eligible to participate?

No! Your medical history does not impact your eligibility for the study in any way unless you have a medical condition that impacts your ability to read and understand the study materials.

Do I have to share my health information to participate?

Yes, you must share your pregnancy-related medical record information to participate in the study. Sharing your records is done online and usually takes only a few minutes. There are instructions for how to do so in the participant guide. The information you share has the potential to make a significant impact on building knowledge in this area. To learn more about the information collected visit BUMP EMR data explained.

Why do I have to share my medical record data?

Relevant sections of your electronic medical chart information will be used to better understand your pregnancy experience, and interpret the objectively measured information that you share from the study wearable devices.

How do I know my data is secure?

We take several steps to ensure your data is kept confidential and secure. All data stored on your phone is encrypted and sent to our study server in a secure manner using Transport Layer Security. Your study data is associated with a unique identifier, while any personally identifiable information we collect from you is stored in a separate location from your study data. All of your data is securely stored in accordance with all local state laws, regulations, and IRB policies.

Am I able to use either an iPhone or an Android?

Yes! You must use a smartphone to participate in the study, and either an iPhone or an Android phone is acceptable. You must have an iPhone SE or newer or an Android version 6.0 or newer, and you must be willing to upgrade to the most recent operating system for your phone. The study’s coordinators can help you upgrade if you need assistance.

What is the Oura ring and what does it measure?

The Oura ring is a smart ring that uses sensors to help track your health and measure specific vital signs.
Specifically, the Oura ring measures:

  • Heart Rate: Your heart rate
  • Resting Heart Rate: Your heart rate when you are at rest
  • Heart rate variability: The measure of variations in time (milliseconds) between your heartbeats
  • Respiration rate: How frequently you breathe while you sleep
  • Breathing variance: Any variation or changes in your respiration rate
  • Sleep stages: (Light, deep, REM) and quality of your sleep
  • Body temperature: including any fluctuations in temperature
  • Activity levels: The duration, intensity, and timing of when you are active (for
    example, taking a long walk)
  • Inactivity levels: The duration, intensity, and timing of when you are sedentary (for
    example, sitting on the couch)

Learn more about the Oura ring on their website: https://ouraring.com/

What type of Garmin smartwatch will I receive and what does it measure?

The Garmin watch used in the study is the Garmin Venu Sq. Like the Oura ring, the Garmin Venu Sq uses sensors to track health indicators and vital signs.
This watch measures the following:

  • Heart Rate: Your heart rate throughout the day
  • Resting Heart Rate: Your heart rate when you are at rest
  • Heart rate variability: The measure of variations in time (milliseconds) between your
  • Respiration rate: How frequently you breathe
  • Sleep stages: Light, deep, and REM
  • Blood Oxygen Saturation: How well your body absorbs oxygen

Learn more about the Garmin Venu Sq on Garmin’s website: https://buy.garmin.com/en-US/U...

Note: The study only uses the Garmin Venu Sq for participants who are currently pregnant.

If I already use an Apple watch, can I continue to wear that instead of the Garmin?

Yes! If you own an Apple watch you are able to use that device instead of the Garmin watch provided by 4YouandMe.

What is the Bodyport scale and what does it measure?

The Bodyport scale is a smart scale that measures body weight as well as cardiac activity through your feet. You will be asked to weigh yourself with the Bodyport scale once a day for the duration of the study.

Is the Bodyport scale safe to use during pregnancy?

Yes! There are no known risks associated with the use of the Bodyport Scale while pregnant and the device is FDA approved for electrical safety. For more information on the Bodyport scale, visit their website:https://bodyport.com/ .

What benefits come to participants?

While the information learned from participants in this study will only impact women in the future, there are many ways we believe expecting mothers can benefit from participating in this study.
Some examples include:

  • The ability to track your pregnancy-related symptoms
  • A smartwatch and smart ring to monitor your health
  • Opportunity to earn up to $25 for every month of participation
  • A study coordinator who will check in via phone to support you throughout your
    participation in the study

What if I want to end my participation in the study early?

This study is completely voluntary so you can end participation at any time for any reason.

I am potentially interested but would like to speak to someone before signing up.

No problem! We want you to make an informed decision that is right for you. If you have any questions, email bumpstudy@4youandme.org and a study coordinator will reach out to answer them.

I have a friend who is interested in BUMP - can she participate too?

Yes! You are welcome to discuss this study with friends and can give our contact information to anyone who is interested!

To participate, your interested friend must also be over 18 years old and less than 16 weeks pregnant!

You can share this link with your friends so they and learn more and sign up!

I am actively trying to conceive, can I participate in the BUMP Study?

At this time we are only recruiting women who are already pregnant. However, once you get a positive pregnancy test result we would love to have you join!

Please read more about our strategy to protect participants in light of the SCOTUS ruling.