Better Understanding the Metamorphosis of Pregnancy (BUMP)

Completed

• Conditions: Pregnancy Early; Wearables; Pregnancy Related

• Registration Number: NCT04714905
• Lead Sponsor: 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.

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 Timeline

• Study First Submitted: 2021-01-08
• Study First Submitted QC: 2021-01-14
• Study First Posted: 2021-01-20
• Study Start: 2021-02-23
• Primary Completion: 2023-07-03
• Study Completion: 2023-07-03
• Status Verified: 2023-08
• Last Update Submitted: 2023-08-03
• Last Update Posted: 2023-08-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 712

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Study retention	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	3-22 months	Average wearable device usage over study follow-up
App-based active task/survey adherence	3-22 months	Average daily active task and survey completion over study follow-up

Trial Locations

Locations (1)

4YouandMe; 🇺🇸 Seattle, Washington, United States