Better Understanding the Metamorphosis of Pregnancy (BUMP)

NCT04714905 | Completed

• 1 other identifier: 4UBUMP01
• Study Type: observational
• Target: 712
• Locations: 1 country
• Sites: 1

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.

Conditions

Pregnancy Related; Pregnancy Early; Wearables

Keywords

Pregnancy; Wearables

Outcome Measures

Primary Outcomes (3)

• 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

  3-22 months

• Wearable device adherence

  Average wearable device usage over study follow-up

  3-22 months

• App-based active task/survey adherence

  Average daily active task and survey completion over study follow-up

  3-22 months

Study Arms (2)

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.

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Pregnant woman or anticipating to be pregnant.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• Pregnant (up to and including 15 weeks) (Pregnancy cohort)
• Anticipating to be pregnant (Pre-pregnancy cohort)
• + years (Pregnancy cohort)
• 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

You may not qualify if:

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

Sponsors & Collaborators

• 4YouandMe: lead
• Sema4: collaborator
• Evidation Health: collaborator
• Vector Institute of Artificial Intelligence: collaborator
• Cambridge Cognition Ltd: collaborator
• Bodyport Inc.: collaborator
• Community Health Center, Inc.: collaborator

Study Sites (1)

4YouandMe

Seattle, Washington, 98121, United States

Location

Study Officials

• Stephen Friend, PhD, MD

  4YouandMe

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 8, 2021
• First Posted: January 20, 2021
• Study Start: February 23, 2021
• Primary Completion: July 3, 2023
• Study Completion: July 3, 2023
• Last Updated: August 7, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, 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.

Locations

US (1)