BUMP

Goal/Objective:

The Better Understanding the Metamorphosis of Pregnancy (BUMP) study was designed to derive novel insights and deeper understanding of maternal experience with an aim to follow eight core symptoms of pregnancy (emesis, fatigue, edema, mood, cognition, dyspnea, gait, and hypertension) through the use of connected devices such as wearable devices, smart home scales and smartphone apps. Our goal is to learn how best to provide knowledge and support to women during this major period of change. Despite pregnancy being a commonly occurring medical event that poses health risks to the pregnant woman and fetus, there is limited understanding of individual level experiences and on how to prevent and treat symptoms before they become higher risk complications.

Description of the study:

This BUMP study will collect passive and active measures of physiological, psychological, cognitive, sleep and physical symptoms from women who are either pregnant, or anticipate to become pregnant. This wide array of objective and subjective measures of health will be collected from a central study app, a smart wristwatch, a smart scale, and a smart ring. These digital data will be complimented by information derived from standard of care clinical visits, while participants will be provided with knowledge (insights about their own symptoms), and support by phone check-ins with engagement specialists during participation. We are recruiting women through Sema4’s patient provider platform in the US.

Size and Timing:
The main BUMP study launched in February 2021. We plan to digitally enroll and follow a target of 1000 women. Participants will be enrolled over a 10 month period, and followed for 6 up to 18 months depending on starting time and pregnancy status.

Sponsor:
4YouandMe

Clinical Partner(s):
Virtual study not associated with a particular institution.

Coalition and Collaboration Partners:
This study is a collaboration between the 4Youandme, Sema4, Evidation, Cambridge Cognition, Bodyport, and Vector Institute.

clinicaltrials.gov