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Trial record 1 of 2 for:    wearables | Pregnancy
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Better Understanding the Metamorphosis of Pregnancy (BUMP) (BUMP)

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ClinicalTrials.gov Identifier: NCT04714905
Recruitment Status : Recruiting
First Posted : January 20, 2021
Last Update Posted : March 11, 2021
Sponsor:
Collaborators:
Sema4
Evidation Health
Vector Institute of Artificial Intelligence
Cambridge Cognition Ltd
Bodyport Inc.
Information provided by (Responsible Party):
4YouandMe

Brief 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.

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.


Condition or disease
Pregnancy Related Pregnancy Early Wearables

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 2, the Garmin Venu Sq and the Bodyport scale. The study will follow women anticipating becoming pregnant and those pregnant up to and including 13 weeks.

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 1000 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 12 Months
Official Title: Better Understanding the Metamorphosis of Pregnancy
Actual Study Start Date : February 23, 2021
Estimated Primary Completion Date : March 2023
Estimated Study Completion Date : March 2023

Group/Cohort
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.



Primary Outcome Measures :
  1. 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


  2. Wearable device adherence [ Time Frame: 3-22 months ]
    Average wearable device usage over study follow-up

  3. App-based active task/survey adherence [ Time Frame: 3-22 months ]
    Average daily active task and survey completion over study follow-up



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Pregnant woman or anticipating to be pregnant.
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
The pre-pregnancy cohort involves tracking symptoms in women anticipating to become pregnant. The pregnancy cohort involves tracking symptoms during pregnancy
Criteria

Inclusion Criteria:

  • 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
  • Has consented to participate in the Sema4 Research Repository (e.g., agreed to have their EMR data accessed by Sema4)

Exclusion Criteria:

  • Prisoner
  • Unable to read or understand the study materials
  • Does not have a permanent address
  • Intention to terminate pregnancy at the time of enrollment

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04714905


Contacts
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Contact: Stephen Friend, PhD, MD 215-421-3073 friend@4youandme.org
Contact: Diane Mackenzie diane@4youandme.org

Locations
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United States, Washington
4YouandMe Recruiting
Seattle, Washington, United States, 98121
Contact: Stephen Friend, MD, PhD       friend@4youandme.org   
Contact: Diane Mackenzie       diane@4youandme.org   
Sponsors and Collaborators
4YouandMe
Sema4
Evidation Health
Vector Institute of Artificial Intelligence
Cambridge Cognition Ltd
Bodyport Inc.
Investigators
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Principal Investigator: Stephen Friend, PhD, MD 4YouandMe
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Responsible Party: 4YouandMe
ClinicalTrials.gov Identifier: NCT04714905    
Other Study ID Numbers: 4UBUMP01
First Posted: January 20, 2021    Key Record Dates
Last Update Posted: March 11, 2021
Last Verified: March 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: 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.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Analytic Code
Time Frame: Internal researchers will have access to all coded data during the full duration of the study. Consented participants' coded data will be available in the Synapse at Sage Bionetworks for selected researchers to access indefinitely, one year after study completion.
Access Criteria: We will combine the coded study data from all the study participants. Subsets of the coded study data will be made accessible to researchers according to a tiered permission: Internal Researchers (Vector Institute, Evidation Health, and Sema4) will have access to all coded data during the full duration of the study. Collaboration Partners (CamCog and Bodyport) may be given access to a subset of coded data streams, with the exclusion of the video diary, any location data, and any social network data, quarterly during the data collection period. Each partner will additionally have the data collected by their respective system (e.g. Garmin will access data collected off the Garmin device). The research queries being conducted on the coded data is limited to the study of emesis, gait, cognition, preeclampsia, depression/anxiety, edema, sleep/stress and social wellbeing.
URL: https://www.synapse.org/

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by 4YouandMe:
Pregnancy
Wearables