PreTel, Inc. — Department of Health and Human Services SBIR Phase I: NICHD

Description

Approximatelyof all women in the USoverannuallyare exposed to IV oxytocin at some point during labor to increase the frequency and strength of uterine contractionsOxytocin is classified as a high alert medication requiring clinical vigilanceOxytocin is generally safebut adverse outcomes arise when contractions become too frequenta condition called tachysystoleTachysystole is associated with fetal distress resulting in emergency Cesarean deliveryRRneonatal sepsisRRNICU admissionsRRand depressed fetal outcomesRRTo dateclinical vigilance alone has not sufficiently reduced these oxytocin related clinical risksThere are marked variations of individual responses to oxytocinwith some patients contracting robustly at low doseswhile others require high doses to express mild contractionsWithout a reliablenon invasive method to monitor the effects of oxytocin on the uterusit remains difficult to effectively administerThe use of tocodynamometrytocothe standard method of assessing contractions during laborunfortunately results inof patients experiencing tachysystoleThis high rate is a serious gap in obstetrical practiceElectromyography offers an alternate method of assessing uterine contractions since bioelectrical signals are produced as the muscle contractsInterestinglyit long been appreciated that uterine bioelectrical signals are also produced between contractionsThese signals are the source offalse positive contractionreporting in commercial EMG based systemsHoweverto date there have been no explanations of the sourceimportanceor meaning of these signalsIn our preliminary uterine EMG studieswe found thesebetween contractionssignals are prominent during oxytocin useFurthermoreas the uterine contraction pattern approaches tachysystoleour analysis suggests that oxytocin associated EMG signals last longerminutesand appear more frequentlyIn subjects that meet the clinical criteria of tachysystolethe oxytocin associated signals are seen in all channels and persist even longertominutesIn this Phase I SBIR projectwe will show the feasibility of isolating the oxytocin associated signals from raw data in real timeAimIn Aimwe will use these signals to categorize the uterine contractions asnormalearly oxytocin effectsprecursor to tachysystoletachysystoleIdentifying the precursor to tachysystole will allow clinicians to know when additional oxytocin infusion is inadvisable and avoid tachysystoleThis will close the gap in the practice of oxytocin management for induction of labor Oxytocin is frequently used during labor to enhance uterine contractions and implement deliveryToo much oxytocin causes the contractions to occur too frequentlycalled tachysystoleand increases the risks to mothers and babiesIn this project we develop a new method to assess the effects of oxytocin on the uterusa categorization of uterine contractions from normal to tachysystolewhich will identify when to clinically intervene before the onset of tachysystole