Pregnancy RelatedBUMPNCT04714905
Better Understanding the Metamorphosis of Pregnancy (BUMP)
An observational study of Pregnancy Related and Pregnancy Early, run by 4YouandMe at 1 site in United States.
Trial summary
Pregnancy is a commonly occurring medical event. Women who are pregnant may experience pregnancy-related symptoms and complications. However, there is a relative lack of multi-dimensional data on large populations of pregnant patients. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pregnancy Related, Pregnancy Early, Wearables
- How many people
- 712 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Feb 2021to 3 Jul 2023
- How long will I take part?
- 12 Months
- Phase
- Observational
- 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 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: The pre-pregnancy cohort involves tracking symptoms in women anticipating to become pregnant. The pregnancy cohort involves tracking symptoms during pregnancy
Who may be able to join
- Pregnant (up to and including 15 weeks) (Pregnancy cohort)
- Anticipating to be pregnant (Pre-pregnancy cohort)
- 18+ years (Pregnancy cohort)
- 18-40 years (Pre-pregnancy cohort)
- Has a personal cell phone that is an iPhone SE or newer or an Android device, version 6.0 or newer, and is willing to upgrade to the most recent operating system and use their phone for study (This includes a willingness to download and use the study applications and sync their phone with the necessary study devices)
- Has an unshared email address
- Proficient in English language
Who cannot join
- Prisoner
- Unable to read or understand the study materials
- Does not have a permanent address
- Intention to terminate pregnancy at the time of enrolment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Better Understanding the Metamorphosis of Pregnancy
Pregnancy is a commonly occurring medical event. Women who are pregnant may experience pregnancy-related symptoms and complications. However, there is a relative lack of multi-dimensional data on large populations of pregnant patients.
The Study Investigators aim to derive novel insights and deeper understanding of maternal physiology and pathology through the analysis of an unprecedented breadth and depth of data collected from connected devices (i.e., wearables, smart home scale, mobile apps, etc.), additional virtual study assessments and support calls, and information derived from standard of care clinical visits. They will share these insights to empower patients to better care for themselves.
The Investigators hope to know how leveraging the data collected from connected devices in addition to information obtained from routine clinical care helps researchers and clinicians better understand pregnancy related symptoms, conditions, and complications.
Read the detailed description
During pregnancy a woman may experience symptoms that are specific to being pregnant, including nausea, fatigue, shortness of breath, insomnia etc. to much more complicated and serious symptoms. While pregnancy is a commonly occurring medical event that poses health risks to the pregnant woman and fetus, there is limited research on how to prevent and treat symptoms before they become higher risk complications. Utilizing mHealth technology for the collection of objective and subjective measurements and the integration of passive data (from connected devices) will increase understanding of pregnancy and subsequent complications and symptoms as indicative or predictive of particular outcomes.
In order to mitigate the risks of pregnancy, pregnant women are monitored closely and frequently through periodic in-clinic visits with their clinician. However, little is known about the progression of symptoms and measurements between clinic visits as continuous data is not collected as part of clinical practice.
Symptom trajectories have been historically characterized by sporadic visible data, insufficient to identify transition points. Visible data points are episodic and may (or may not) be captured by monthly clinical assessments during pregnancy, but invisible data points can be captured and more clearly defined through the use of longitudinal, passive data collection by wearing and connecting devices.
The Study Investigators aim to detect individual symptom transitions and shift trajectories of health to those which cannot be confined to the standard office clinical visit. They have selected devices which may help track the symptoms including The Oura Ring, the Garmin Venu Sq and the Bodyport scale. The study will follow women anticipating becoming pregnant and those pregnant up to and including 15 weeks.
- Conditions
- Pregnancy Related, Pregnancy Early, Wearables
- Keywords
- Pregnancy, Wearables
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Pregnant Cohort | Pregnant (up to and including 15 weeks), 18+ years of age. | |
| Pre-pregnancy Cohort | Anticipating to be pregnant, 18-40 years of age. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Study retention
Proportion of participants completing the study Completion of 70% of data collection points (active tasks, surveys) per study participant.
Correlations between objective sensor data with active measurements of pregnancy symptoms
Measured: 3-22 months
Wearable device adherence
Average wearable device usage over study follow-up
Measured: 3-22 months
App-based active task/survey adherence
Average daily active task and survey completion over study follow-up
Measured: 3-22 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2021
- Study start23 Feb 2021
- Primary completion3 Jul 2023
- Study completion3 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pregnancy RelatedStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 712 participants (actual)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- 4YouandMe
- Sponsor type
- University, hospital or other
- Collaborators
- Sema4, Evidation Health, Vector Institute of Artificial Intelligence, Cambridge Cognition Ltd, Bodyport Inc., Community Health Center, Inc.
- Responsible party
- Sponsor
- Investigators
- Stephen Friend, PhD, MD, Principal investigator, 4YouandMe
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04714905
- Sponsor's protocol ID
- 4UBUMP01
- Acronym
- BUMP
- Status last verified
- Aug 2023
- First submitted
- 8 Jan 2021
- Last updated
- 7 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Under the 4YouandMe open source model, we will make all data, findings, digital health applications and algorithms available in the public domain. Accordingly, de-identified data produced from this project will be shared broadly with qualified researchers through Sage Bionetworks Synapse Only data from consenting participants will be shared through Sage Bionetworks Synapse and this will not include video diary data, relative location data or social media data. Additionally, source code for the developed app will be made available as open source software on GitHub so it can be evolved for future work by others. Our coalition partners that will have access to all coded data include Vector, 4YouandMe, Evidation Health and Sema4, while our collaboration partners (Bodyport and Cambridge Cognition) will have access to subsets of the coded study data not including video diary data, relative location data, or social media data.
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Better Understanding the Metamorphosis of Pregnancy
- ClinicalTrials.gov ID
- NCT04714905
- Acronym / sponsor ID
- BUMP / 4UBUMP01
- Conditions
- Pregnancy Related, Pregnancy Early, Wearables
- Keywords
- Pregnancy, Wearables
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 712 participants (actual)
- Lead sponsor
- 4YouandMeUniversity, hospital or other
- Collaborators
- Sema4, Evidation Health, Vector Institute of Artificial Intelligence, Cambridge Cognition Ltd, Bodyport Inc., Community Health Center, Inc.
- Study start
- 23 Feb 2021 (actual)
- Primary completion
- 3 Jul 2023 (actual)
- Study completion
- 3 Jul 2023 (actual)
- First posted
- 20 Jan 2021 (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.
Pregnancy is a commonly occurring medical event. Women who are pregnant may experience pregnancy-related symptoms and complications. However, there is a relative lack of multi-dimensional data on large populations of pregnant patients.
The Study Investigators aim to derive novel insights and deeper understanding of maternal physiology and pathology through the analysis of an unprecedented breadth and depth of data collected from connected devices (i.e., wearables, smart home scale, mobile apps, etc.), additional virtual study assessments and support calls, and information derived from standard of care clinical visits. They will share these insights to empower patients to better care for themselves.
The Investigators hope to know how leveraging the data collected from connected devices in addition to information obtained from routine clinical care helps researchers and clinicians better understand pregnancy related symptoms, conditions, and complications.
Detailed description
During pregnancy a woman may experience symptoms that are specific to being pregnant, including nausea, fatigue, shortness of breath, insomnia etc. to much more complicated and serious symptoms. While pregnancy is a commonly occurring medical event that poses health risks to the pregnant woman and fetus, there is limited research on how to prevent and treat symptoms before they become higher risk complications. Utilizing mHealth technology for the collection of objective and subjective measurements and the integration of passive data (from connected devices) will increase understanding of pregnancy and subsequent complications and symptoms as indicative or predictive of particular outcomes.
In order to mitigate the risks of pregnancy, pregnant women are monitored closely and frequently through periodic in-clinic visits with their clinician. However, little is known about the progression of symptoms and measurements between clinic visits as continuous data is not collected as part of clinical practice.
Symptom trajectories have been historically characterized by sporadic visible data, insufficient to identify transition points. Visible data points are episodic and may (or may not) be captured by monthly clinical assessments during pregnancy, but invisible data points can be captured and more clearly defined through the use of longitudinal, passive data collection by wearing and connecting devices.
The Study Investigators aim to detect individual symptom transitions and shift trajectories of health to those which cannot be confined to the standard office clinical visit. They have selected devices which may help track the symptoms including The Oura Ring, the Garmin Venu Sq and the Bodyport scale. The study will follow women anticipating becoming pregnant and those pregnant up to and including 15 weeks.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 12 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pregnant Cohort | – | –Pregnant (up to and including 15 weeks), 18+ years of age. |
| Pre-pregnancy Cohort | – | –Anticipating to be pregnant, 18-40 years of age. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The pre-pregnancy cohort involves tracking symptoms in women anticipating to become pregnant. The pregnancy cohort involves tracking symptoms during pregnancy
Key inclusion criteria (7 listed)
- Pregnant (up to and including 15 weeks) (Pregnancy cohort)
- Anticipating to be pregnant (Pre-pregnancy cohort)
- 18+ years (Pregnancy cohort)
- 18-40 years (Pre-pregnancy cohort)
- Has a personal cell phone that is an iPhone SE or newer or an Android device, version 6.0 or newer, and is willing to upgrade to the most recent operating system and use their phone for study (This includes a willingness to download and use the study applications and sync their phone with the necessary study devices)
Key exclusion criteria (4 listed)
- Prisoner
- Unable to read or understand the study materials
- Does not have a permanent address
- Intention to terminate pregnancy at the time of enrolment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Study retention
Time frame: 3-22 months
Proportion of participants completing the study Completion of 70% of data collection points (active tasks, surveys) per study participant. Correlations between objective sensor data with active measurements of pregnancy symptoms
Wearable device adherence
Time frame: 3-22 months
Average wearable device usage over study follow-up
App-based active task/survey adherence
Time frame: 3-22 months
Average daily active task and survey completion over study follow-up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2023.
- Individual participant dataSharing planned: Yes. Under the 4YouandMe open source model, we will make all data, findings, digital health applications and algorithms available in the public domain. Accordingly, de-identified data produced from this project will be shared broadly with qualified researchers through Sage Bionetworks Synapse Only data from consenting participants will be shared through Sage Bionetworks Synapse and this will not include video diary data, relative location data or social media data. Additionally, source code for the developed app will be made available as open source software on GitHub so it can be evolved for future work by others. Our coalition partners that will have access to all coded data include Vector, 4YouandMe, Evidation Health and Sema4, while our collaboration partners (Bodyport and Cambridge Cognition) will have access to subsets of the coded study data not including video diary data, relative location data, or social media data.
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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.
Stephen Friend, PhD, MD principal investigator
4YouandMe
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pregnancy Related and Pregnancy Early, run by 4YouandMe 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 7 inclusion and 4 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: finished, as of the sponsor's last update on 7 Aug 2023. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Study retention (time frame: 3-22 months). The study lists 3 primary outcomes in all. 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 7 Aug 2023.