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Completed

NCT Number: NCT04714905

Better Understanding the Metamorphosis of Pregnancy (BUMP)

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.

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Key information

Conditions

Pregnancy Related Pregnancy Early Wearables

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

4YouandMe

Seattle, Washington, 98121, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  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

Sponsors and collaborators

Lead sponsor

4YouandMe

Other

Collaborators

  • Bodyport Inc.
  • Cambridge Cognition Ltd
  • Community Health Center, Inc.
  • Evidation Health
  • Sema4
  • Vector Institute of Artificial Intelligence

Registry information

Official study title

Better Understanding the Metamorphosis of Pregnancy

Acronym: BUMP

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Jan 20, 2021
Registry last updated
Aug 7, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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