Biosensor for Detecting Fetal Growth Restriction in a Low-Resource Setting

Anders Jacobsen,Omari A Msemo,Bjarke Sørensen,Birgitte Bruun Nielsen,John P A Lusingu,Sofie Lykke Møller,Karsten Nielsen,Morten Hedegaard,Daniel T R Minja,Christentze Schmiegelow,Diana Riknagel

doi:10.3390/reprodmed2010007

Abstract

One strategy for improving detection of fetal growth restriction (FGR) is developing biosensors identifying placental dysfunction as a leading pathogenesis for FGR. The aim of this pilot study was to investigate the performance of a biosensor specified to detect placental dysfunction by means of maternal arterial turbulence acoustics in a low-resource setting. A cohort of 147 singleton pregnant women were prospectively followed with double-blinded biosensor tests, sonographic estimation of fetal weight (EFW) and Doppler flow at 26–28, 32–34 and 37–39 weeks of pregnancy. Full term live births with recorded birth weights (BWs) and without major congenital malformations were included. Outcomes were defined as (A) a solitary biometric measure (BW < 3rd centile) and as (B) a biometric measure and contributory functional measure (BW < 10th centile and antenatally detected umbilical artery pulsatility index > 95th centile). Data from 118 women and 262 antenatal examinations were included. Mean length of pregnancy was 40 weeks (SD ± 8 days), mean BW was 3008 g (SD ± 410 g). Outcome (A) was identified in seven (6%) pregnancies, whereas outcome (B) was identified in one (0.8%) pregnancy. The biosensor tested positive in five (4%) pregnancies. The predictive performance for outcome (A) was sensitivity = 0.29, specificity = 0.97, p = 0.02, positive predictive value (PPV) was 0.40 and negative predictive value (NPV) was 0.96. The predictive performance was higher for outcome (B) with sensitivity = 1.00, specificity = 0.97, p = 0.04, PPV = 0.20 and NPV = 1.00. Conclusively, these pilot-study results show future potential for biosensors as screening modality for FGR in a low-resource setting.

Highlights

The clinical effort of identifying fetal growth restriction (FGR) is substantial [1] and crucial as FGR is associated with more than half of all still-births as well as long-term health with increased risk of cardiovascular disease for survivors [1,2,3]
The FOETALforNCD study was an interdisciplinary study of 1415 preconception women and 538 pregnant women to investigate the role of anemia in early life for non-communicable diseases (NCDs) in later life [15]
Among the 118 women included for investigation of the predictive performance of the biosensor, a total of 262 antenatal examinations were conducted

Summary

Introduction

The clinical effort of identifying fetal growth restriction (FGR) is substantial [1] and crucial as FGR is associated with more than half of all still-births as well as long-term health with increased risk of cardiovascular disease for survivors [1,2,3]. Empirical studies on partly occluded arteries, as in cases of coronary artery stenosis, show that acoustic turbulent blood flow appears in a distinct frequency spectrum > 200 Hz [9]. Laminar flow in arteries is silent whereas turbulent blood flow creates pulse-sounds clinically known as arterial murmurs [9,10]. Findings on the physiological properties of blood flow in relation to abnormal placentation show that the inflow of maternal blood into the intervillous space (IVS) is turbulent [11], and velocity is increased by a factor 10–20 compared to that of normal placentation [12]

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Discussion

Conclusion