Wearable-Derived Maternal Heart Rate Variability As A Novel Digital Biomarker of Preterm Birth

Abstract

Despite considerable health consequences from preterm births, their incidence remains unchanged over recent decades, due partially to limited screening methods and limited use of extant methods. Wearable technology offers a novel, noninvasive, and acceptable way to track vital signs, such as maternal heart rate variability (mHRV). Previous research observed that mHRV declines throughout the first 33 weeks of gestation in term, singleton pregnancies, after which it improves. The aim of this study was to explore whether mHRV inflection is a feature of gestational age or an indication of time to delivery. This retrospective case-control study considered term and preterm deliveries. Remote data collection via non-invasive wearable technology enabled diverse participation with subjects representing 42 US states and 16 countries. Participants (N=241) were recruited from the WHOOP (Whoop, Inc.) userbase and wore WHOOP straps during singleton pregnancies between March 2021 and October 2022. Mixed effect spline models by gestational age and time until birth were fit for within-person mHRV, grouped into preterm and term births. For term pregnancies, gestational age (AIC = 26627.6, R2m = 0.0109 , R2c= 0.8571) and weeks until birth (AIC =26616.3, R2m = 0.0112 , R2c = 0.8576) were representative of mHRV trends, with significantly stronger fit for weeks until birth (relative log-likelihood ratio = 279.5). For preterm pregnancies, gestational age (AIC =1861.9, R2m = 0.0016, R2c = 0.8582) and time until birth ( AIC = 1848.0, R2m = 0.0100, R2c = 0.8676) were representative of mHRV trends, with significantly stronger fit for weeks until birth (relative log-likelihood ratio= 859.4). This study suggests that wearable technology, such as the WHOOP strap, may provide a digital biomarker for preterm delivery by screening for changes in nighttime mHRV throughout pregnancy that could in turn alert to the need for further evaluation and intervention.

Competing Interest Statement

ERC, SRJ, and DMP are all employees of WHOOP Inc.

Funding Statement

This study did not receive any funding.

Author Declarations

I confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained.

Yes

The details of the IRB/oversight body that provided approval or exemption for the research described are given below:

The Institutional Review Board of Advarra (Columbia, MD) waived ethical approval for this work.

I confirm that all necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived, and that any patient/participant/sample identifiers included were not known to anyone (e.g., hospital staff, patients or participants themselves) outside the research group so cannot be used to identify individuals.

Yes

I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance).

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I have followed all appropriate research reporting guidelines and uploaded the relevant EQUATOR Network research reporting checklist(s) and other pertinent material as supplementary files, if applicable.

Yes

Data Availability

Add data produced in the present study are protected intellectual property of WHOOP, Inc., however may be made available upon request for researchers who meet the criteria for access to confidential information.

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