- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04714905
Better Understanding the Metamorphosis of Pregnancy (BUMP) (BUMP)
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.
Study Overview
Status
Conditions
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 Type
Enrollment (Actual)
Contacts and Locations
Study Contact
- Name: Stephen Friend, PhD, MD
- Phone Number: 215-421-3073
- Email: friend@4youandme.org
Study Contact Backup
- Name: Diane Mackenzie
- Email: diane@4youandme.org
Study Locations
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Washington
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Seattle, Washington, United States, 98121
- 4YouandMe
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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
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 enrolment
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
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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 the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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 |
3-22 months
|
Wearable device adherence
Time Frame: 3-22 months
|
Average wearable device usage over study follow-up
|
3-22 months
|
App-based active task/survey adherence
Time Frame: 3-22 months
|
Average daily active task and survey completion over study follow-up
|
3-22 months
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Stephen Friend, PhD, MD, 4YouandMe
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
- ANALYTIC_CODE
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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