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Is abdominal fetal electrocardiography an alternative to doppler ultrasound for FHR variability evaluation?

Jeżewski, Janusz

Abstract

Great expectations are connected with application of indirect fetal electrocardiography (FECG), especially for home telemonitoring of pregnancy. Evaluation of fetal heart rate (FHR) variability, when determined from FECG, uses the same criteria as for FHR signal acquired classically-through ultrasound Doppler method (US). Therefore, the equivalence of those two methods has to be confirmed, both in terms of recognizing classical FHR patterns: baseline, accelerations/decelerations (A/D), long-term variability (LTV), as well as evaluating the FHR variability with beat-to-beat accuracy-short-term variability (STV). The research material consisted of recordings collected from 60 patients in physiological and complicated pregnancy. The FHR signals of at least 30 min duration were acquired dually, using two systems for fetal and maternal monitoring, based on US and FECG methods. Recordings were retrospectively divided into normal (41) and abnormal (19) fetal outcome. The complex process of data synchronization and validation was performed. Obtained low level of the signal loss (4.5% for US and 1.8% for FECG method) enabled to perform both direct comparison of FHR signals, as well as indirect one-by using clinically relevant parameters. Direct comparison showed that there is no measurement bias between the acquisition methods, whereas the mean absolute difference, important for both visual and computer-aided signal analysis, was equal to 1.2 bpm. Such low differences do not affect the visual assessment of the FHR signal. However, in the indirect comparison the inconsistencies of several percent were noted. This mainly affects the acceleration (7.8%) and particularly deceleration (54%) patterns. In the signals acquired using the electrocardiography the obtained STV and LTV indices have shown significant overestimation by 10 and 50% respectively. It also turned out, that ability of clinical parameters to distinguish between normal and abnormal groups do not depend on the acquisition method. The obtained results prove that the abdominal FECG, considered as an alternative to the ultrasound approach, does not change the interpretation of the FHR signal, which was confirmed during both visual assessment and automated analysis.

Full text

ORIGINAL RESEARCH published: 16 May 2017 doi: 10.3389/ phys.2017.00305 F on ie s in Physiology | www. on ie sin.o g 1May 2017 | Volume 8 | A icle 305 Edi ed by: Ahsan H. Khandoke , Khali a Uni e si y, UAE Re iewed by: Hai ham Alanga i, Khali a Uni e si y, UAE Faezeh Ma zban ad, Monash Uni e si y, Aus alia Yoshi aka Kimu a, Tohoku Uni e si y, Japan *Co espondence: Janusz W obel [email p o ec ed] Special y sec ion: This a icle was submi ed o Compu a ional Physiology and Medicine, a sec ion o he jou nal F on ie s in Physiology Recei ed: 20 Ma ch 2017 Accep ed: 27 Ap il 2017 Published: 16 May 2017 Ci a ion: Jezewski J, W obel J, Ma onia A, Ho oba K, Ma inek R, Kupka T and Jezewski M (2017) Is Abdominal Fe al Elec oca diog aphy an Al e na i e o Dopple Ul asound o FHR Va iabili y E alua ion? F on . Physiol. 8:305. doi: 10.3389/ phys.2017.00305 Is Abdominal Fe al Elec oca diog aphy an Al e na i e o Dopple Ul asound o FHR Va iabili y E alua ion? Janusz Jezewski1, Janusz W obel1*, Adam Ma onia1, K zysz o Ho oba1, Radek Ma inek2, Tomasz Kupka1and Michal Jezewski3 1Ins i u e o Medical Technology and Equipmen ITAM, Zab ze, Poland, 2Depa men o Cybe ne ics and Biomedical Enginee ing, VSB-Technical Uni e si y o Os a a, Os a a, Czechia, 3Ins i u e o Elec onics, Silesian Uni e si y o Technology, Gliwice, Poland G ea expec a ions a e connec ed wi h applica ion o indi ec e al elec oca diog aphy (FECG), especially o home elemoni o ing o p egnancy. E alua ion o e al hea a e (FHR) a iabili y, when de e mined om FECG, uses he same c i e ia as o FHR signal acqui ed classically— h ough ul asound Dopple me hod (US). The e o e, he equi alence o hose wo me hods has o be con i med, bo h in e ms o ecognizing classical FHR pa e ns: baseline, accele a ions/decele a ions (A/D), long- e m a iabili y (LTV), as well as e alua ing he FHR a iabili y wi h bea - o-bea accu acy—sho - e m a iabili y (STV). The esea ch ma e ial consis ed o eco dings collec ed om 60 pa ien s in physiological and complica ed p egnancy. The FHR signals o a leas 30 min du a ion we e acqui ed dually, using wo sys ems o e al and ma e nal moni o ing, based on US and FECG me hods. Reco dings we e e ospec i ely di ided in o no mal (41) and abno mal (19) e al ou come. The complex p ocess o da a synch oniza ion and alida ion was pe o med. Ob ained low le el o he signal loss (4.5% o US and 1.8% o FECG me hod) enabled o pe o m bo h di ec compa ison o FHR signals, as well as indi ec one—by using clinically ele an pa ame e s. Di ec compa ison showed ha he e is no measu emen bias be ween he acquisi ion me hods, whe eas he mean absolu e di e ence, impo an o bo h isual and compu e -aided signal analysis, was equal o 1.2 bpm. Such low di e ences do no a ec he isual assessmen o he FHR signal. Howe e , in he indi ec compa ison he inconsis encies o se e al pe cen we e no ed. This mainly a ec s he accele a ion (7.8%) and pa icula ly decele a ion (54%) pa e ns. In he signals acqui ed using he elec oca diog aphy he ob ained STV and LTV indices ha e shown signi ican o e es ima ion by 10 and 50% espec i ely. I also u ned ou , ha abili y o clinical pa ame e s o dis inguish be ween no mal and abno mal g oups do no depend on he acquisi ion me hod. The ob ained esul s p o e ha he abdominal FECG, conside ed as an al e na i e o he ul asound app oach, does no change he in e p e a ion o he FHR signal, which was con i med du ing bo h isual assessmen and au oma ed analysis. Keywo ds: Dopple ul asound, e al elec oca diog am, e al hea a e analysis, e al s a e assessmen , e al ou come Jezewski e al. FHR om: aFECG s. US INTRODUCTION Fe al hea ac i i y is a p ima y sou ce o in o ma ion which enables assessmen o he e al s a e du ing p egnancy and a labo . This in o ma ion is ob ained mainly h ough analysis o he e al hea a e (FHR) signal being o med om he ins an aneous alues calcula ed acco ding o he o mula: FHR [bpm] =60000/T [ms]. The FHR alues a e exp essed in bea s pe minu e, and T is he ime in e al be ween wo consecu i e e al hea bea s ha comp ises one comple e ca diac cycle. Toge he wi h addi ional signals desc ibing he u e ine con ac ile ac i i y and e al mo emen p o ile, he FHR signal cons i u es he ca dio ocog aphic eco d. Acquisi ion o hese addi ional signals is qui e simple, bu measu emen o he e al hea a e has been always a challenge. Al eady in 1960s he e al elec oca diog am was eco ded o he i s ime by means o elec ode a ached o e al head. The quali y o such eco ded di ec e al elec oca diog am (FECG) is usually e y good, and hus i enables, using a qui e simple p ocessing me hod, de e mina ion o he bea - o-bea in e als wi h e y high accu acy. Howe e , he in asi e app oach and applica ion limi ed o he labo only caused ha di ec me hod did no ound wide applica ion in clinical p ac ice. As a esul o u he esea ch and de elopmen he nonin asi e ul asound (US) me hod has become a s anda d app oach since ea ly 1970s, as i can be used bo h du ing p egnancy and labo . A p esen , all bedside e al moni o s in ended o use in clinical condi ions a e based on he pulsed Dopple ul asound echnique, wi h measu emen ansduce a ached o ma e nal abdomen. P inciple o ope a ion elies on in e nal p ocessing o he en elope o he US beam e lec ed om mo ing pa s o e al hea s— al es o walls, o ind he episodes co esponding o consecu i e hea bea s. Howe e , a complex s uc u e and a ying con en o he US signal, usually caused by eloca ion o he e al hea in ela ion o a ansduce du ing moni o ing session, make a de e mina ion o he bea - o-bea in e al e y di icul (Khandoke e al., 2009; Ma zban ad e al., 2014). The e o e, a co ela ion echniques, conside ing ull shape o he analyzed signal, ha e been applied. The c oss-co ela ion echnique wi h changeable empla e appea ed o be oo sensi i e o US signal changes, which esul ed in conside able signals loss. Thus, an au oco ela ion unc ion wi h adap i e window selec ion has been applied in nex gene a ion e al moni o s. Howe e , he au oco ela ion unc ion does no de ec he consecu i e hea bea s bu only de e mines he ins an aneous pe iodici y o he US signal en elope which co esponds o ca diac cycle being measu ed. This leads o e ec o a e aging o neighbo ing ca diac cycles and hus dec easing o FHR de e mina ion accu acy in ela ion o e al elec oca diog aphy (Lee e al., 2009; Voicu e al., 2010). The ob ained FHR signal is p o ided by he bedside moni o as he ace in a p in ou wi h es ablished ime scale o 1, 2, o 3 cm/min. As long as he FHR ace has been analyzed isually, he lowe accu acy did no a ec signi ican ly he e al s a e assessmen . Mo e impo an was o ensu e he ace con inui y which allowed clinicians o obse e a gene al endency o he e al hea a e changes, and o ecognize he ea u es ep esen ing longi udinal FHR pa e ns ela ing o he e al s a e, like accele a ion o decele a ion. I was ound ha he e alua ion o e al s a e, when based on isual in e p e a ion, has been mainly a ec ed by low in e - and in a- obse e ag eemen (Jezewski e al., 2002; Romano e al., 2016a). Tha was a esul o bo h complexi y o he FHR signal and he ac ha impo an pa o in o ma ion ela ing o ins an aneous changes o FHR alues has been hidden om a naked eye. These changes a e conside ed o be e y impo an FHR cha ac e is ics, e lec ing app op ia e neu ological modula ion o he FHR. Thus, u he de elopmen s age o e al moni o ing was aimed a au oma ed analysis o he FHR signal and i s implemen a ion as buil -in p ocedu e o bedside moni o s as well as in compu e -aided e al moni o ing sys em. Some o he equi emen s impo an o moni o ing he p egnan women in hospi al, like su eillance o many pa ien s, de ec ing and ale ing o symp oms o e al dis ess, o elec onic a chi e wi h he signals and pe ina al da a, ha e made he compu e -aided sys em wi h online au oma ed analysis he s anda d in mode n obs e ics (W obel e al., 2013, 2015a). Au oma ed analysis comp ises de ec ion and desc ip ion o he abo e men ioned FHR ea u es, like accele a ion and o he s, as well as de e mina ion o he ins an aneous FHR changes by p o iding a se o indices o e alua e he long- e m and sho - e m (bea - o-bea le el) a iabili y o he e al hea a e. Au oma ed online analysis p o ides a quan i a i e desc ip ion o he FHR, bu he inal in e p e a ion o he eco d is s ill done by a clinician. The e a e a numbe o pape s ela ing o au oma ed classi ica ion o he FHR eco dings by using di e en me hods o compu a ional in elligence like neu al ne wo k, suppo ec o machines o epsilon-insensi i e lea ning (Czabanski e al., 2008, 2013). Howe e , aking in o accoun ha he inpu da a se comp ised he au oma ically de e mined ea u es o he FHR signals, collec ed om he clinical da abases (Chudacek e al., 2014), he ob ained classi ica ion esul s should be aced o he limi a ions o he ul asound app oach as i is discussed below (Voicu e al., 2014; W obel e al., 2015c). The a iabili y indices we e o iginally de ined using he bea - o-bea in e als de e mined om he di ec elec oca diog am. Thei s aigh applica ion o he FHR signals being p o ided by e al moni o s aised a ques ion how a limi ed accu acy o he ul asound app oach a ec s de e mina ion o he ca diac in e als, and hus he a iabili y indices alues. Se e al esea ch s udies we e aimed a e alua ion o he eliabili y o he ul asound me hod in e e ence o he di ec elec oca diog aphy (Ib ahimy e al., 2003; Reinha d e al., 2010, 2012; Cohen e al., 2012; Kimu a e al., 2012; Desai e al., 2013; Ko ding e al., 2015). Howe e , hey we e aimed a compa ing he signal loss episodes o di ec ly he FHR alues. In ou s udy we showed ha he e o o ca diac cycle de e mina ion (ins an aneous FHR alue) has no been co ela ed wi h he FHR a iabili y indices e o . I means ha he measu emen accu acy esul ing om he e al moni o speci ica ion canno be di ec ly ela ed o he esul s o he compu e -aided analysis o he FHR a iabili y. In gene al, we concluded ha mode n e al moni o s using he Dopple US echnique a e no able o p o ide he signal wi h he accu acy equi ed o eliable quan i a i e e alua ion o ins an aneous FHR a iabili y, pa icula ly he sho - e m F on ie s in Physiology | www. on ie sin.o g 2May 2017 | Volume 8 | A icle 305 Jezewski e al. FHR om: aFECG s. US a iabili y, based on he indices calcula ed au oma ically (Voicu e al., 2014). Fo una ely, he alues o indices de e mined in ha way a e unde es ima ed, which p e en s he e al dis ess signs om being unde ec ed. Se e al a emp s we e ca ied ou o imp o e he eliabili y o he ul asound me hod by using ad anced signal p ocessing o he Dopple en elope (Jezewski e al., 2011), bu none o hem ha e been applied in he bedside moni o s ye . In W obel e al. (2008) he me hod has been p oposed o imp o e he eliabili y o he FHR a iabili y indices, which elies on he e o s ecognized in he ul asound measu emen channel. The ac , ha he FHR signal ob ained om he ul asound app oach has been ecognized as no good enough o ully exploi he po en ial o au oma ed analysis o e ed by compu e - aided e al moni o ing sys em, b ough back an in e es o he e al elec oca diog aphy (Fuchs, 2014). Howe e , aking in o accoun he need o moni o a whole p egnancy pe iod, only a nonin asi e app oach could be conside ed, which elies on indi ec eco ding he FECG om elec odes loca ed on ma e nal abdominal wall (Ungu eanu e al., 2009; Vullings e al., 2010; Kimu a e al., 2012; Khala e al., 2013; Beha e al., 2014; Agos inelli e al., 2015b). Ano he impo an issue o de elopmen o e ec i e abdominal elec oca diog aphy e e s o a g owing in e es in high- isk p egnancy elemoni o ing a home (W obel e al., 2015b). When using he ul asound-based e al moni o he ansduce has o be ca e ully placed o ensu e he ul asound beam is ocused on he e al hea . Wha ’s mo e, du ing moni o ing session he ansduce may equi e eposi ioning due o a change o e us posi ion. O he wise, he signal loss occu s which may cause, in case when a woman pe o ms he moni o ing session alone, he un ounded ea and unp edic able eac ion. When he abdominal elec odes a e ixed on he abdomen, he pa ien can easily e i y he signal loss, which in ha case occu s only when one o he elec odes peels o (Ka ounis e al., 2007; Kolomeye s and Roshche skaya, 2013; Agos inelli e al., 2015b). Imp o emen o he measu emen ins umen a ion, elec ode echnology and he signal p ocessing me hods ha ha e been no iced du ing ecen yea s, enabled o cope wi h he p oblems connec ed wi h de elopmen o he abdominal e al elec oca diog aphy (Ko as, 2008; Vullings e al., 2010). The signal acqui ed om e us head is in ac “pu e” e al elec oca diog am, whe eas he abdominal signal includes also he ma e nal elec oca diog am (MECG) and some noise coming mainly om muscle ac i i y (Ta alunga e al., 2009, 2014; Ma inek e al., 2016). Thus, he c ucial s ep in ex ac ion o he FECG om he abdominal signal is a supp ession o ma e nal elec oca diog am while p ese ing he e al QRS complexes (Melillo e al., 2014; Agos inelli e al., 2015a). The ene gy o MECG is many imes highe han he ene gy o FECG, and wha ’s mo e he equency band o bo h hese componen s pa ly o e laps which makes simple il e ing useless (Ka ounis e al., 2007). A numbe o di e en app oaches o MECG supp ession and de ec ion o e al QRS complexes we e p esen ed in li e a u e (Ungu eanu e al., 2007; Liu and Luan, 2015; Poian Da e al., 2016). The sys em o acquisi ion o abdominal signals and o iginal me hod o FECG ex ac ion we e p oposed by he au ho s, and he indi ec e al elec oca diog aphy was e alua ed in ela ion o he gold s anda d—di ec FECG app oach (Jezewski e al., 2012). Re e ing o he esul s ob ained in ou p e ious s udy, conce ning a compa ison o ul asound app oach wi h he di ec FECG (Jezewski e al., 2006), we concluded ha he abdominal e al elec oca diog aphy p o ides accu acy no wo se han he ul asound me hod does. Howe e , in all s udies whe e he US me hod o abdominal FECG was compa ed wi h di ec FECG, he esul s we e ob ained only o he signals being acqui ed du ing labo . Conside ing ha e al de elopmen , aking place du ing a whole p egnancy pe iod, a ec s he cha ac e is ics o he FHR signals, we decided o ca y ou he compa ison o he abdominal FECG and ul asound me hod based on he signals collec ed du ing p egnancy. I is ob ious ha such app oach excludes he di ec elec oca diog aphy om he s udy, and causes some p oblems o compa ison me hodology due o a lack o e e ence da a (Sa o e al., 2011; Cohen e al., 2012; Kimu a e al., 2012). Since bo h ypes o he signals we e acqui ed by means o wo se s o ins umen a ion, ano he impo an p oblem has been ecognized— he FHR signals synch oniza ion, i.e., inding he co esponding ca diac cycles. I should be no iced ha in case o ul asound-based moni o , he FHR signal is p o ided h ough i s ou pu only as he measu emen alues o ins an aneous hea a e e enly spaced wi h 250 ms. On he o he hand, he sys em o nonin asi e FECG is able o p o ide, along wi h he e enly spaced signal, he ime e en se ies wi h du a ions o consecu i e ca diac cycles. In his wo k he me hodology is p oposed o compa e wo di e en me hods o e al hea a e moni o ing. I s o iginali y ela es o he ac ha compa ison has been ca ied ou no only in ela ion o he co esponding ca diac cycle alues, bu also o he clinically impo an indices desc ibing he ins an aneous FHR a iabili y. METHODS The esea ch ma e ial comp ised he FHR signals acqui ed simul aneously using he Dopple ul asound as well as he elec oca diog aphic me hods in a g oup o 70 p egnan women. F om a numbe o moni o ing sessions pe o med o each pa ien , we selec ed only one eco ding acqui ed a ound 1 week be o e deli e y, wi h a leng h o a leas 30 min (Geo gie a e al., 2014). All he eco dings a e accompanied by in o ma ion on e al ou come: ges a ional age a bi h, blood gas pa ame e s pH and BE, pe cen ile o e al bi h weigh , Apga sco e, in o ma ion abou a possible s ay in he NICU. The pa ien s we e moni o ed by simul aneously using wo popula in ma e ni y wa ds, sys ems o e al and ma e nal moni o ing: MONAKO and KOMPOREL. Un o una ely, hese sys ems we e unable o synch onize eco ded signals du ing he moni o ing session. The ime shi be ween signals beginnings in each session could each up o a ew minu es, whe eas in case o compa a i e s udies he p ecise synch oniza ion is equi ed (e en on he le el o indi idual hea bea s). Hence, he p oblem o signals synch oniza ion has been conside ed as a signi ican challenge. F on ie s in Physiology | www. on ie sin.o g 3May 2017 | Volume 8 | A icle 305 Jezewski e al. FHR om: aFECG s. US As he esul o each simul aneous moni o ing session, wo iles we e ob ained o he na i e o ma , whe e he FHR signal is ep esen ed by he alues measu ed e enly wi h 250 ms pe iod. Files om he MONAKO Sys em comp ise he FHR_U signal cap u ed om he ou pu o e al moni o equipped wi h he ul asound ansduce (Hewle -Packa d M1351). The iles om he KOMPOREL Sys em p o ide he FHR_E signal being de e mined on a basis o e al elec oca diog am eco ded om he abdominal wall o he mo he . The e al elec oca diog am is eco ded by using ou elec odes placed on he ma e nal abdomen. The c ucial s ep in ex ac ion o he FECG om he abdominal signal is a supp ession o ma e nal elec oca diog am while p ese ing he e al QRS complexes (Cas illoa e al., 2013; Ma inek e al., 2015). The p oposed me hod o he MECG supp ession is based on sub ac ing he pa e n o ma e nal P-QRS-T complexes and spa ial il e ing. I ensu es co ec de e mina ion o he iducial poin s as well as he ac o s scaling he pa e n. The algo i hm o de ec ion o he e al QRS complexes is based on a ma ched il e ing app oach in o de o educe he sensi i i y o in e e ences. Addi ionally, he de ec ion is ca ied ou wi h a se o decision ules o p edic he du a ion o he nex bea - o-bea ca diac cycle (Ma onia e al., 2006). As a esul o he FECG analysis, he ime e en se ies is ob ained— as he ime ma ke s when he successi e e al hea bea s we e de ec ed— he QRS complexes, which is hen used o de e mine he FHR_E signal as he alues wi h 250 ms pe iod (Gue e o Ma inez e al., 2006; Almeida e al., 2013, 2014). Signals Synch oniza ion The p ocedu e o synch oniza ion o each pai o he FHR_U and FHR_E signals consis ed o wo s ages. In he i s s age an ini ial isual adjus men was suppo ed by a dedica ed p og am o isualiza ion o he signals. This p og am as well as all he o he s, c ea ed o he pu pose o his wo k, was de eloped in LabView en i onmen (Na ionaI Ins umen s) (Desai e al., 2013). A e coa se synch oniza ion o he signals he common pa o FHR_U and FHR_E signals was sepa a ed. I elied on mo ing he beginning and end o one signal, o indica e he agmen o in e es acco ding o he o he signal. A his s age he signals quali y had o be good enough o allow ecognizing he cha ac e is ic ea u es common o bo h signals, and cons i u ing he so called cen e ing poin s, and he common pa o he signals had o ha e non-ze o leng h. These condi ions we e no me in case o h ee eco dings, hence in u he p ocessing only he se o 67 pa ien s we e included. In he second s age he signal alida ion was conduc ed, as well as p ecise synch oniza ion o bo h signals, a he le el o indi idual FHR alues p o ided e e y 250 ms. The de eloped so wa e enabled semi-au oma ed synch oniza ion. The p og am au oma ically ound he ime shi be ween he signals o ensu e he minimum di e ences be ween he co esponding alues, which mos ly led o p ope synch oniza ion. A e ha , he isual e i ica ion was ca ied ou wi h a possibili y o addi ional ime shi co ec ion, ollowed by he inal accep ance (Figu e 1). The so wa e o de e mina ion o he op imal ime shi be ween he analyzed signals was using he synch oniza ion unc ion based on he mean absolu e di e ences (MAD), de e mined o he co esponding (applying he ime shi ) FHR_U and FHR_E alues. To imp o e he pe o mance o synch oniza ion unc ion i was necessa y o u he educe he in luence o andom in e e ences appea ing in he FHR signals, as well as sudden alue changes esul ing om he measu emen e o s o po en ial accele a ion and decele a ion episodes. Hence, he segmen s wi h sudden changes in he FHR signal we e excluded om he unc ion de e mina ion, i he absolu e di e ence be ween a gi en alue and he p eceding one was highe han 10 bpm (Spilka e al., 2012). I a gi en FHR alue was ejec ed, he nex one was compa ed o he mean calcula ed om he p e ious alues (including he ejec ed) in he 240 alues window. The FHR alues we e also ejec ed om he signal, which we e suspec ed o ep esen he ma e nal hea a e— he de ails o he algo i hm a e p esen ed in W obel e al. (2015b). This ype o e oneous measu emen s occu s in he FHR_U signal, as i is ypical o he ul asound me hod and qui e equen in he US-based e al moni o s. The abo e-men ioned p ep ocessing is only in ended o synch onize he signals and do no change hei in o ma ion con en . The op imum ime shi , co esponding o he ully synch onized signals, was ob ained o he unc ion minimum, when applying addi ional shi in he ange om −25 o +25 FHR alues (measu ed e e y 250 ms), in espec o he signals synch onized a e he i s s age. I a he beginning o end o a gi en signal any in e e ence associa ed wi h he s a o end o he moni o ing session occu ed, hey we e also emo ed in he imming p ocess. T imming o he ull minu es in u n, esul s om he ac ha he analysis o he ins an aneous FHR a iabili y is always ca ied ou wi hin a 1-min signal segmen s. Finally, as a esul o he synch oniza ion p ocedu e some signal pai s could be sho ened by as much as 4 min. A e he second s age o synch oniza ion he common pa o he analyzed signals is immed o he la ges whole numbe o he minu es ( he numbe o FHR alues was a mul iple o 240). We assumed ha he minimum leng h o synch onized signals (cons i u ing he pai ) subjec ed o u he analysis should be 10 min. Acco ding o ha c i e ion only one eco ding was ejec ed, and 66 eco dings we e le . Signal Loss Analysis The nex p ocessing s ep consis ed o e i ying he signal pai s in e ms o hei quali y, measu ed bo h by a size and na u e o he signal loss episodes. Episodes o signal loss a e p elimina ily de ec ed by he moni o ing sys ems used, and ep esen ed by ze o alues in he FHR signal. Fo he pu pose o his wo k also he po en ial e oneous FHR alues, as no mee ing he adop ed c i e ia, we e ma ked as signal loss episodes, using he dedica ed de eloped p og am. Signal segmen s we e conside ed o be signal loss i hey did no mee he an Geijn modi ied c i e ion ( an Geijn, 1980), p oposed in Jezewski e al. (2012). Tha was applied o hese FHR alues, which we e conside ed as e o s by a p ocedu e o sudden changes emo al used in he second s age o synch oniza ion. In his case, he es ablished h esholds a e: he absolu e di e ence be ween a gi en FHR alue and he p eceding one g ea e han 20 bpm, and window wid h equals o 100 alues. The segmen s, suspec ed o con ain F on ie s in Physiology | www. on ie sin.o g 4May 2017 | Volume 8 | A icle 305 Jezewski e al. FHR om: aFECG s. US FIGURE 1 | The sc een illus a ing he ope a ion o he p ocedu e o synch onizing he wo signals, de e mined ia he ul asound ( ed FHR_U) and elec oca diog aphic (blue FHR_E) me hods. (A) P esen s he concep o au oma ed synch oniza ion ia minimizing he mean e o . The cu en alue o he mean absolu e di e ence MAD pa ame e is displayed on he gauge. Au o mode had au oma ically se up he alue o he shi pa ame e o 9 samples o wa d. Howe e , basing on a isual analysis o he signals, ha shi was manually co ec ed using a slide — he FHR_U signal was shi ed by 2 samples backwa d in ela ion o he FHR_E signal. (B) Shows he enla ged signal agmen om pa A, bu a e a p ocedu e o emo ing he sudden FHR changes. I allows o addi ional manual synch oniza ion and inal alida ion o he eco ding o u he in es iga ions. he ma e nal hea a e signal, we e indica ed as he signal loss episodes—simila ly as in he second s age o synch oniza ion. Finally, as a esul o he signal loss analysis, he FHR_U and FHR_E signals we e ob ained wi h addi ional in o ma ion abou de ec ed gaps (FHR alues equal o ze o). The signal loss le el is de ined as a pe cen age o he du a ion o signal loss episodes ( he numbe o FHR alues equal o ze o) in ela ion o he o al du a ion o he signal (all FHR alues). Taking in o accoun he maximum le el o signal loss o 30% in ei he FHR_U o FHR_E signal, i e eco dings we e emo ed. Addi ionally, in e ms o uni o mi y o signal loss dis ibu ion in ime, ou ques ionable eco dings wi h signal loss be ween 20 and 30% we e isually assessed. Only one eco ding was excluded due o he accumula ion o he signal loss (equal o 23%) in he middle pa o he FHR_U signal. The inal esea ch ma e ial consis ed o signal pai s om 60 moni o ing session. The o al leng h o eco dings was equal o 1995 min. The leng h o indi idual eco dings a ied om 11 o 64 min, wi h an a e age o 33.3 min. Di ec Signals Compa ison Fo he inal se o eco dings, consis ing o he FHR_U and FHR_E signal pai s, some desc ip i e s a is ics o signal compa ison we e calcula ed, bo h on a global basis as well as a he le el o pa icula FHR alues. These s a is ics include (calcula ed o indi idual eco dings): he eco ding du a ion, signal loss le el, mean alue o he di e ences be ween he co esponding ins an aneous FHR alues (MD), s anda d de ia ion (SD), mean absolu e di e ence (MAD), as well as he summa y s a is ics o he en i e esea ch ma e ial. The di e ence be ween he pai s o co esponding ins an aneous alues o FHR_U and FHR_E was exp essed dually: as he hea bea s pe minu e (bpm) as well as in milliseconds. The second ep esen a ion is ob ained by con e sion o he FHR alues in o in e als be ween successi e hea bea s, acco ding o he hype bolic ans o ma ion wi h he 60,000 ac o . As equally impo an i is assumed he compa ison o he signals in a o ma commonly used in au oma ed analysis o he low a iabili y FHR signal componen s (Jezewski e al., 2002). In his o ma he successi e alues o he signal a e de e mined by a e aging 10 consecu i e o iginal FHR alues ( ime se ies measu ed e e y 250 ms). Impo an pa in he a e aging p ocess is he emo al o he signal loss episodes, ma ked as ze o alues. I , while a e aging 10 o iginal FHR alues, mo e han ou alues a e ma ked as signal loss, he esul ing alue o 2.5 s pe iod is also conside ed as signal loss and is assigned wi h ze o alue. Indi ec Signal Compa ison ia Clinical Pa ame e s As shown in he li e a u e (Jezewski e al., 2016), he di e ences om he di ec compa ison o signals a e o en no co ela ed F on ie s in Physiology | www. on ie sin.o g 5May 2017 | Volume 8 | A icle 305 Jezewski e al. FHR om: aFECG s. US wi h di e ences in alues o clinically impo an pa ame e s o quan i a i e desc ip ion o FHR signal, de e mined by he e al moni o ing sys ems (Geo gie a e al., 2012). These pa ame e s a e used by clinicians, in e p e ing he FHR signals in o de o assess he e al s a e. The e o e, i was conside ed as impo an o iden i y he impac o he FHR signal acquisi ion me hod on he clinically signi ican pa ame e s. Fo ha pu pose, he synch onized FHR_U and FHR_E signals we e sa ed in o he na i e o ma iles (measu ed wi h 250 ms) and eloaded o he a chi e o MONAKO Sys em. Thanks o an op ion o eanalysis o he a chi al eco ds, o each o 60 eco dings (120 FHR signals), he quan i a i e pa ame e s desc ibing he a iabili y pa e ns de ec ed in he FHR signal we e de e mined au oma ically. As he esul , he lis s o pa ame e s we e ob ained o he FHR_U and FHR_E signals. They included he pa ame e s desc ibing some pa e ns o FHR a iabili y in he ime domain: mean alue o FHR (M_FHR), mean alue o he FHR baseline (M_BL), numbe o de ec ed accele a ion (ACC) and decele a ion (DEC) episodes (Geo gie a e al., 2012; W obel e al., 2013). Addi ionally, an assessmen o he ins an aneous FHR a iabili y was p o ided as: du a ion and alue o he high (HE_D and HE_V) and low (LE_D and LE_V) a iabili y episodes, a e age alue o he long- e m a iabili y (LTV) and sho - e m a iabili y (STV) indices, as well as he FHR oscilla ions (OSC) oge he wi h he pe cen age o di e en oscilla ion ypes (OSC_I÷OSC_IV) (Jezewski e al., 2016). Inconsis encies o he abo e pa ame e s calcula ed o he co esponding FHR_U and FHR_E signals we e es ima ed using he symme ic mean pe cen age di e ence SMPD, whe e he di e ences be ween alues a e ela ed o hei mean. Since he no mali y assump ion was e i ied using he Shapi o-Wilk es , he s a is ical signi icance (using pai ed S uden ’s - es ) o he di e ences be ween he co esponding pa ame e s ob ained in he FHR_U and FHR_E signals was examined. Indi ec Signals Compa ison ia Bea - o-Bea Va iabili y I is gene ally belie ed ha a e y high p edic i e alue in ela ion o he ea ly de ec ion o he e al dis ess is p o ided by he ins an aneous FHR a iabili y pa ame e s (Cesa elli e al., 2009). They a e de e mined om he FHR signal in a o m o he ime e en se ies—a sequence o e en s une enly loca ed in ime, p o iding he successi e ca diac cycles du a ion exp essed in milliseconds. This o ma signi ican ly di e s om ha a ailable a he ou pu o a e al moni o — he FHR alues e enly spaced a e e y 250 ms. This measu emen pe iod has been es ablished o be no longe han he sho es physiologically allowed hea cycle, howe e wi h cha ac e is ic in o ma ion edundancy o low FHR alues (e.g., he FHR alue equal o 50 bpm is ep esen ed by ou duplica ed subsequen alues; Lee e al., 2009; Goncal es e al., 2013). The e o e, he FHR_U and FHR_E signals we e subjec ed o econs uc ion o he abo e men ioned ime e en se ies ep esen a ion. This p ocedu e elied on aking om he e enly dis ibu ed ime se ies, he alues acco ding o he iming signal being cons i u ed by he e al QRS complexes addi ionally ob ained om he KOMPOREL Sys em. The esul ing signal is a sequence o ime-o de ed e en s co esponding o subsequen occu ences o he e al QRS complexes (o mo e p ecisely he R-wa es). C ea ed acco ding o he desc ibed p ocedu e he FHR_U and FHR_E signals in he o m o ime e en se ies, p o ided he basis alues o de e mina ion o he ins an aneous a iabili y indices. These indices, widely acclaimed in he li e a u e (Romano e al., 2016b), quan i a i ely desc ibe he long- and sho - e m FHR a iabili y. In his s udy he ollowing indices we e analyzed: Haan_LTI, Haan_STI, Yeh_II, Yeh_STI, O gan_LTV, O gan_STV, Dal on_LTV, Dal on_STV, Zugaib_LTV, Zugaib_STV. In o de o s anda dize he esul s he indices we e de e mined wi hin 1-min segmen s (Kubo e al., 1987; Jezewski e al., 2006). Each consecu i e segmen comp ised only hose ins an aneous FHR alues which we e de e mined using he hea bea s con ained in he gi en segmen (Cesa elli e al., 2009). While p ocessing a gi en segmen , i pe cen age o alid alues, ele an o a gi en index (acco ding o i s de ini ion), was less han 20%, i was assumed ha he index alue was unde e mined o ha minu e. Such cases a e he esul o he signal loss episodes in he analyzed signals. In a se ies o minu e alues calcula ed o a gi en signal, hey a e de ined as a 1-min loss o he gi en index alue and ma ked wi h he alue o −1. The index a e age alue o a gi en signal is calcula ed om all 1-min alues, excluding hose ma ked as unde e mined. Addi ionally, a non-linea pa ame e o ins an aneous FHR a iabili y was p oposed, in a o m o he egula i y measu e— he sample en opy index (SampEn) (Signo ini and Magenes, 2014). I was de e mined in he windows co e ing 300 hea e en s (FHR alues), and exp essed in milliseconds as a measu e o pe iod. The pa ame e s o SampEn unc ion we e se a : dim =1 and =0.1. Fo he gi en signal, he SampEn index ep esen s he mean alue o sample en opy de e mined in successi e windows. Inconsis encies o indices desc ibing he ins an aneous FHR a iabili y, de e mined o co esponding FHR_U and FHR_E signals we e e alua ed wi h he SMPD, whe e he di e ence be ween alues a e ela ed o hei mean. The s a is ical signi icance (using pai ed S uden ’s - es ) o he di e ences be ween he alues o he indices ob ained o each signal pai was also examined. Indi ec Signals Compa ison ia Fe al Ou come P edic ion Analysis o he FHR signal leads o i s classi ica ion as co esponding o no mal o abno mal e al s a e. Since a he ime o e al moni o ing, he e is no o he diagnos ic me hod which could be able o con i m a co ec ness o he signal classi ica ion, he FHR signals, being acqui ed du ing p egnancy, a e e ospec i ely assigned o ue e al ou come (newbo n s a e) (Chudacek e al., 2014; Romano e al., 2016a). I is jus i ied, as in obs e ics i is assumed ha he no mal e al ou come has o be esul o p ope e al de elopmen du ing he p egnancy pe iod. Excluding he cases when he labo p ocess i sel caused nega i e e ec s o he e al s a e, he same assump ion can be applied F on ie s in Physiology | www. on ie sin.o g 6May 2017 | Volume 8 | A icle 305 Jezewski e al. FHR om: aFECG s. US o abno mal e al ou come. I is gene ally belie ed ha his ela ionship is main ained in case o deli e ies by cesa ean sec ion due o he ma e nal easons. In he collec ed da abase he as majo i y o cases we e o his ype. The 60 pa ien s ( eco dings) we e classi ied as belonging o a no mal o abno mal g oup using he in o ma ion on e al ou come. The abno mal s a e was se i a leas one o he ollowing condi ions was me : Apga sco e (a 5 min) <7, pH <7.2, BE >12, NICU s ay >24 h, o bi h weigh pe cen ile <5%. Finally, he esea ch ma e ial included 19 eco dings wi h abno mal s a e and 41 wi h no mal s a e assigned e ospec i ely. I is impo an ha o he majo i y o pa ien s wi h abno mal e al ou come, he p egnancy was ended by cesa ean sec ion due o he ma e nal indica ions (16 cases). I sugges s ha cou se o deli e y imposed no nega i e e ec on he newbo n. The da abase con ains six eco dings o which he abno mal s a e was se due o h ee o mo e condi ions me . The analysis o abili y o p edic ion o he e al ou come was pe o med sepa a ely o he ul asound and he e al elec oca diog aphy app oaches. Each FHR_U (FHR_E) signal was ep esen ed by he ea u e se comp ising: 15 pa ame e s de e mined by he MONAKO Sys em, 10 indices desc ibing he ins an aneous FHR a iabili y and SampEn en opy measu e. The di e ences be ween he alues o hese ea u es ob ained in wo g oups (no mal and abno mal e al ou come) we e exp essed by he mean pe cen age di e ence (MPD) o bo h g oups— whe e he no mal ou come g oup was aken as e e ence. The s a is ical signi icance o he di e ence be ween he mean alues o each ea u e ob ained o wo g oups was assessed using S uden ’s - es . The indi ec compa ison o FHR_U and FHR_E signals, as o p edic ing he e al ou come, was based on he capabili y o classi y he FHR signals om a gi en acquisi ion me hods in o no mal and abno mal analyzing he de e mined clinical FHR pa ame e s. RESULTS Compa ison analysis conside ing wo di e en me hods o FHR signal acquisi ion has been ca ied ou using 60 pai s o FHR_E and FHR_U signals, which we e ob ained du ing he moni o ing sessions o 60 pa ien s. A e a ull signals synch oniza ion and imming, he o al leng h o eco dings was equal o 1995 min, wi h an a e age leng h o 33.3 min (SD =10.9 min). The eco dings we e cha ac e ized by low signal loss (de ails in Table 1). Fo he US me hod he mean signal loss was equal o 4.5%, whe eas o he FHR signals ob ained ia FECG, he loss le el was mo e han wo imes lowe , which is exp essed by he mean signal loss o only 1.8%. High signal loss was obse ed in ew eco dings, especially o FHR_U. I could be no ed ha o mo e han hal o he eco dings, he signal loss o bo h me hods did no exceed 1%. Such low le el o he signal loss and he su icien leng h o indi idual eco dings enabled u he es ima ion o he inconsis ency be ween bo h acquisi ion me hods, using he mean alues o clinical quan i a i e pa ame e s, de e mined du ing he FHR signal analysis. A di ec compa ison o he FHR_E and FHR_U signals has been based on es ima ion o he di e ences be ween he co esponding ins an aneous FHR alues (p o ided e e y 250 ms). I enabled he me ological assessmen o he inconsis ency be ween he wo acquisi ion me hods. Compa ison a ha s age was pe o med o each indi idual eco ding and he summa y o desc ip i e s a is ics o en i e esea ch ma e ial is p esen ed in Table 1. The mean di e ence alue (MD) ob ained o all eco dings was −0.23 bpm, which in ela ion o an a e age alue o FHR (abou 140 bpm) gi es a ela i e e o o 0.2%. I means ha he measu emen bias be ween he wo me hods does no occu . When analyzing he MD alues calcula ed o pa icula eco dings we no ed ha i did no depend on he measu ed FHR signal alue. I is shown by he Bland-Al man plo o MD alues agains he a e age FHR alues ( om FHR measu ed a 250 ms) ob ained o pa icula eco dings (Figu e 2). F om he poin o iew o bo h isual and au oma ed assessmen o he FHR signal a iabili y, he mo e impo an seems o be he MAD, which was equal o 1.24 bpm o all he conside ed signals. Such alue does no a ec a isual e alua ion o he signal, since i is lowe han he p in ing esolu ion o he FHR wa e o ms, as well as he esolu ion o a human eye. In he compu e -aided sys em, he au oma ed analysis aimed a de e mina ion o clinically impo an FHR pa e ns is ca ied ou using he FHR alues a e aged o e 2.5 s. I makes he compa ison be ween FHR_E and FHR_U signals ep esen ed by such a e aged alues especially impo an . A e aging p ocesses caused a sligh dec ease o he signal loss in bo h ypes o TABLE 1 | Desc ip i e s a is ics o he signal loss and alues o di e ences MD, MAD, de e mined o he inal se o eco dings om he elec oca diog aphy (FECG) and he ul asound me hod (US), whe e he FHR signals we e exp essed as he o iginal 250 ms measu es, and as he alues a e aged o e 2.5 s pe iods. FHR 250 ms FHR 2.5 s Signal loss (%) FECG-US (bpm) FECG-US (ms) Signal loss (%) FECG-US (bpm) FECG US MD MAD MD MAD FECG US MD MAD Mean 1.80 4.53 −0.23 1.24 0.71 3.83 1.35 4.29 −0.09 0.71 SD 3.01 6.52 0.38 0.46 1.25 1.62 2.59 6.42 0.40 0.43 Median 0.60 0.95 −0.19 1.12 0.59 3.36 0.35 0.75 −0.05 0.58 Min 0.00 0.10 −1.29 0.50 −4.52 1.39 0.00 0.00 −1.50 0.23 Max 14.70 26.80 1.54 2.86 5.33 9.91 12.50 26.40 1.49 2.50 F on ie s in Physiology | www. on ie sin.o g 7May 2017 | Volume 8 | A icle 305 Jezewski e al. FHR om: aFECG s. US FIGURE 2 | Bland Al man plo showing he dependence o he mean alue o he di e ences MD (Y axis) be ween co esponding ins an aneous alues o FHR_U and FHR_E, in ela ion o he a e age e al hea a e in he eco ding (X axis), o each o he 60 pai s o signals. The alues a e exp essed in bea s pe minu e—bpm. signals, o he alues: 4.3% in US, and 1.4% in FECG (Table 1). Compa ison a his s age was pe o med o pa icula eco dings and he summa y o desc ip i e s a is ics o en i e esea ch ma e ial is p esen ed in Table 1. In gene al, inconsis ency be ween FHR signals a e a e aging dec eased. In his case, he bias be ween he wo me hods also does no occu . The MAD alue has dec eased signi ican ly, o only 0.7 bpm, which is below he 1 bpm le el— he minimum accu acy o he FHR measu emen . In ela ion o he a e age alue o he FHR signal (140 bpm), he ela i e inconsis ency was equal o 0.5%. Conside ing hese esul s we could assume ha such small inconsis ency should lead o he simila alues o clinical pa ame e s p o ided by bo h me hods. Howe e , we ha e o keep in mind ha some o hese pa ame e s a e pa icula ly sensi i e o he FHR changes, being a esul no only o he mean FHR di e ence, bu a he o he dis ibu ion o FHR di e ences in ime. In con as , some o he pa ame e s o he FHR signal a e sensi i e o empo a y high di e ences in he FHR signals. So, in case o hese pa ame e s he di e ences be ween bo h me hods may occu . Such o mula ed assump ions ha e been e i ied in he nex s age o he inconsis ency analysis— he indi ec compa ison o bo h signals. I was based on he in e p e a ion o he di e ences be ween he pa icula FHR signal pa ame e s, which a e p o ided by an au oma ed analysis in he e al moni o ing sys em. Desc ip i e s a is ics (mean alues and SD) o indi idual pa ame e s desc ibing quan i a i ely he FHR signal, which ha e been de e mined o signals om bo h me hods, a e p esen ed in Table 2. Fo each pa ame e he di e ences be ween he FHR_E and FHR_U signals, we e assessed using he SMPD. I was jus i ied because o any o hose pa ame e s no signi ican di e ence be ween hem was no ed. As i could be expec ed, he low SMPD alue o 0.1% ob ained o M_FHR and M_BL pa ame e s (being signi ican ly dependen on an a e aging p ocess o he FHR measu emen s), was simila o he ela i e inconsis ency epo ed in he di ec signals compa ison. In u n, he SMPD alues calcula ed o he ollowing pa ame e s: HE_D, LE_D, STV, ACC, DEC, OSC_IV, di e signi ican ly om he alues epo ed o o he pa ame e s, and e en mo e TABLE 2 | Values o clinically impo an pa ame e s o quan i a i e desc ip ion o FHR-E and FHR-U signals, om FECG and US, ob ained in a compu e -aided e al moni o ing sys em, oge he wi h he symme ic mean pe cen age di e ence SMPD es ima ing he inconsis encies be ween bo h he me hods. Pa ame e s FHR_E FHR_U SMPD (%) Mean SD Mean SD M_FHR (bpm) 143.19 9.35 143.32 9.49 −0.1 M_BL (bpm) 141.70 9.55 141.79 9.60 −0.1 ACC (numbe ) 6.62 5.31 6.12 5.29 7.8 DEC (numbe ) 0.40 0.87 0.23 0.56 54.0 LTV (ms) 39.54 11.90 37.91 11.40 4.2 STV* (ms) 6.35 2.41 5.68 2.02 11.1 HE_D (min) 12.72 12.15 10.60 11.49 18.2 LE_D (min) 7.85 8.01 8.72 7.91 −10.5 HE_V (ms) 53.59 9.67 54.99 7.81 −2.6 LE_V (ms) 18.67 3.22 18.78 3.39 −0.6 OSC (ms) 13.40 3.80 12.91 3.70 3.7 OSC_I (%) 10.51 14.39 11.05 15.30 −5.0 OSC_II (%) 27.77 15.59 29.29 15.39 −5.3 OSC_III (%) 45.31 18.19 45.48 19.11 −0.4 OSC_IV (%) 8.96 9.25 7.81 9.06 13.7 *p<0.05 (pai ed - es ). om he esul s o he di ec compa ison. I con i ms he abo e men ioned assump ion ha some pa ame e s (e.g., STV) a e sensi i e o dis ibu ion o he FHR di e ences in ime, whe eas ano he ones (e.g., DEC) o a empo a y high di e ence alue. Pa icula ly, high SMPD =54% no ed o he numbe o ecognized decele a ions, is a esul s o wo ac o s: he di ec di e ences be ween he signal alues and he di e ences in he signal loss episodes. The signal loss o FHR_U is on a e age wice highe han o FHR_E. In addi ion, he au oco ela ion echnique, commonly used in he US me hod o de e mine he signal pe iodici y, is o en no able o ollow he apid dec ease o FHR signal ela ed o decele a ion, which esul s in signal loss episodes (Figu e 3). This, in u n, causes ha he decele a ion is F on ie s in Physiology | www. on ie sin.o g 8May 2017 | Volume 8 | A icle 305 Jezewski e al. FHR om: aFECG s. US no ecognized, because i does no mee he es ablished c i e ia o ampli ude and du a ion. Indi ec compa ison o he FHR_U and FHR_E signals was pe o med on he basis o he a iabili y indices de ined o signal ep esen ed as ime e en se ies— he hea bea s. Summa y o he esul s (mean alues, SD, and SMPD) o he selec ed 11 pa ame e s desc ibing he FHR signal a iabili y is p esen ed in Table 3. The esul s clea ly show ha he FHR_E signal is cha ac e ized by highe a iabili y hen he FHR_U. Inconsis encies o he long- e m a iabili y indices we e a abou 10%, whe eas o he sho - e m indices hey we e i e imes highe , eaching abou 50%. Fo he sho - e m a iabili y we no iced signi ican di e ence o bo h me hods. TABLE 3 | Resul s o he FHR_E and FHR_U signal analysis, conce ning he long- and sho - e m a iabili y, calcula ed using signal in a o m o ime e en se ies—a sequence o e en s une enly localized in ime, oge he wi h he SMPD alues es ima ing he inconsis encies be ween bo h he me hods. Index FHR_E FHR_U SMPD (%) Mean SD Mean SD Haan_LTI 21.89 14.69 20.62 14.59 6 Yeh_II 1022.89 1.60 2.57 1.53 12 O gan_LTV 8.18 4.46 7.35 4.35 11 Dal on_LTV 12.18 6.68 10.78 6.36 12 Zugaib_LTV 1022.22 1.25 2.01 1.21 10 Haan_STI 103# 6.29 1.94 3.10 1.02 68 Yeh_DI 103# 6.08 2.33 3.62 1.30 51 Geijn_STV* 15.27 23.70 8.98 13.51 52 Dal on_STV#1.80 0.65 1.01 0.32 56 Zugaib_STV 103# 2.77 1.02 1.76 0.58 45 SampEn+1.57 0.57 1.27 0.48 21 *p<0.03; +p<0.001; #p<0.0001 (pai ed - es ). Wi h ega d o such la ge inconsis encies i has o be decided which o he wo me hods may be conside ed as p o iding he FHR a iabili y desc ip ion being close o he ue one. The answe is no ob ious, because in his wo k no e e ence signal was acqui ed simul aneously wi h wo analyzed me hods. Such gold s anda d can be p o ided by p e iously men ioned he di ec e al elec oca diog aphy, whe e he pu e FECG is acqui ed om he e al head. In he p e ious s udies whe e he FHR signal om ul asound me hod was compa ed wi h he e e ence one, i has been shown ha ul asound me hod unde es ima es he sho - e m a iabili y on a le el be ween 20 and 40% in e e ence o di ec e al elec oca diog aphy. A simila end can be seen in Table 3, whe e he FHR_U is compa ed wi h FHR_E ob ained om he abdominal e al elec oca diog am. The signal da abase has been di ided in o wo g oups: no mal and abno mal, acco ding o he es ablished e al ou come c i e ia. The desc ip ion o wo signal g oups is shown in Table 4. Summa y o he FHR signal analysis esul s, comp ising 15 clinical pa ame e s de e mined o bo h g oups o e al ou come, a e shown sepa a ely o he ul asound me hod (Table 5) and abdominal elec oca diog aphy (Table 5). In addi ion o he mean alue and s anda d de ia ion, he mean pe cen age di e ence MPD was calcula ed, assuming he alues ob ained in no mal e al ou come g oup as he e e ence. Apa om assessing he s a is ical signi icance o he di e ence be ween he no mal and abno mal g oups, also he endency o changes was s udied o he pa icula pa ame e s be ween hese g oups. I was ca ied ou o check whe he he obse ed endency would be consis en wi h he clinical in e p e a ion o hose pa ame e s. Conside ing he numbe o ACC pa e ns, a signi ican di e ence be ween he abno mal and no mal g oups was no ed, and he endency was consis en . Bu o he numbe o DEC pa e ns no signi ican di e ence was obse ed. The MPD ook he opposi e alues: nega i e alue o ul asound (−48%) and posi i e o elec oca diog aphy (38%). Thus, a clinical in e p e a ion o decele a ions as a sign o e al dis ess has been con i med FIGURE 3 | An example o a 12-min agmen o signal pai — esul o an indi ec compa ison o e alua e he impac o he FHR signal acquisi ion me hod on clinically ele an pa ame e s, de e mined by a compu e -aided e al moni o ing sys em. The au oco ela ion echnique, commonly used in he US me hod o de e mine he signal pe iodici y, is o en no able o ollow he apid dec ease o FHR_U signal ela ed o decele a ion, which esul s in signal loss episodes. This, in u n, causes ha he decele a ion is no ecognized, because i does no mee he es ablished c i e ia o ampli ude and du a ion. G aphic ma ke s o he analysis esul s illus a e he signal loss (abo e he cu e), he es ima ed FHR baseline (line i ed on FHR cu e) and de ec ed decele a ion episodes (ho izon al ba s unde he cu e). F on ie s in Physiology | www. on ie sin.o g 9May 2017 | Volume 8 | A icle 305