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2/28/18 NeedSpecificationDocuments-OBGYN

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OBSTETRICS&GYNECOLOGYThese unmet clinical needswere identified following an 8-week clinical immersion that wasconducted by a team inObstetrics andGynecology. The clinical immersionwas conducted inhighvolumetertiarycarecentres inSouth India.Weobservedwhat’sdoneandhow itaffectsthe provider, the patient, and the system. This was followed by a peripheral immersion tonumerousprimary,secondaryandtertiaryhealthcarecentresacrossIndia.Theclinicalneedsfoundinthetertiarycarehospitalwerevalidatedinother largecentresandnewprimaryandsecondaryspecificunmetneedswereaddedon.At theendof2monthsofclinical immersion,theteamhadover100detailedobservationswithsignificantnegativeoutcomesand150unmetclinicalneeds.Theseneedswerethenfilteredusingobjectiveparameters,detailedbelow:

THEFILTERINGPROCESS:3STAGESOFFILTERING

Level1:Thelevel1filtereliminatedthoseneedswhichareredundant,pharmaceuticalrelatedorprocessrelated.

Level2:Thisleveloffilteringfocusedontheseverityofclinicalcondition(intheperceptionofobservers and clinicians) aswell as the epidemiologyof thediseaseand the frequencyof thenegative outcome. This data was then validated by a comprehensive literature review ofincidenceandprevalencedata.Ascoringsystemof1–3–5wasusedthroughtheprocess.

Epidemiology

• Frequencyofproblemasperclinician(numberofcasespermonth)• <5patientspermonth =1• 6-12patientspermonth =3 • >13patientspermonth =5

• Frequency of problem as per observers (number of cases seen permonth during theclinicalimmersion)

• <2patientspermonth =1• 2-5patientspermonth =3 • >5patientspermonth =5

Criticality

• Short lasting, reversible: Not resulting in death, disability, hospitalization, orsocioeconomicstress =1

• Resulting in death, hospitalization >3 days, disability/ handicap (> 6 months), largefinancialburdentothepatient/family=5

• Needsinbetween1and5 =3

ObservedEpidemiology and criticality score: 3 (Frequencyof clinician)+ Frequencyofobserver+3(Criticalityscore)


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Target patient population in a given year: We used data wherever available for India.However,inmanycasesduetothedearthofvalidatedhealthstatistics,certainassumptionshadtobemadeusingacombinationofdatafromIndiaandglobalepidemiologicaldata.

• <100,000patients/year =1• 100,000–500,000patients/year =3• >500,000patients/year =5

Secondaryresearchbasedepidemiologyandcriticalityscore:Targetpatientpopulation*Criticalityscore

Filter2score:Subjectiveepidemiologyandcriticalityscore+secondaryresearchbasedepidemiologyandcriticalityscore

Level3:Thethirdleveloffilteringevaluatedthetechnicalcomplexityofthesolutionsavailable,theregulatorylandscapeandthebuyerenvironment.

Number of predicates: This wasmade based on the solutions which currently exist as perguidelinesandthosebeingusedintheIndianclinicalsetting.Bothatprevailingpracticeaswellasgoldstandardswereconsidered.

• Highnumberofpredicatesi.e.>5 =1• Mediumnumberofpredicatesi.e.1to5 =3• Nopredicates =5

Technicalcomplexityofpredicates:Thisfilterconsideredthetechnologybehindthesolutionas well as the expertise needed to implement it in current clinical practice. A mediumcomplexity solution is rated the highest, followed by low complexity and lastly by a highlycomplexsolution.

• High =1• Medium =5• Low =3

Regulatoryandclinicaltrialcomplexity:Thisfilterwasbasedontheregulatoryhurdlesandclinicaltrialsonewouldhavetoconductforaparticularsolution.Itwasajudgmentcallbasedon the current predicates in the system and the classification of devices as per the GlobalHarmonisationTaskForce classification (ClassA - LowRisk, ClassB - Low toModerateRisk,ClassC-ModeratetoHighRisk,ClassD-HighRisk)

• High(ClassD) =1• Medium(ClassC) =3• Low(ClassA&B) =5

Buyer environment: This filter was based on the eventual buyer of a particular medicalsolution.Thisinturndependedonwhichlevelinthehealthcaresystemtheparticularconditionwas treated. The peripheral immersion helped understand, more thoroughly, the referralsysteminIndiawhichdefinedthisfilter.

• High(TertiaryCareCentre) =5• Medium(SecondaryCentre) =3• Low(Individual/Primarycentre) =1


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Filter 3 score =Number of predicates score+Regulatory and clinical trial complexityscore+Buyerenvironmentscore

FinalScore=Filter2score+(Filter3)/4


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NEEDSPECIFICATIONDOCUMENTS1.FETALDISTRESS&INTRAUTERINEFETALDEATH

INTRODUCTION

FetalDistress(FD)isacomplicationoflabor.Itoccurswhenthefetusdoesnotreceiveenoughoxygen.Fetaldistressmayalsooccurwhenthepregnancylaststoolong(postmaturity).

Usually, doctors identify fetal distress based on an abnormal fetal heart rate pattern. In suchcases,thefetus’heartrateismonitoredcontinuously.Itisusuallymonitoredcontinuouslywithelectronic fetal heart monitoring or, a hand-held Doppler ultrasound device may be used tochecktheheartrateevery15minutesduringearlylaborandaftereachcontractionduringlatelabor.[1]

OBSERVATION

Female, 24 years, pregnant for the third time and currently at 40weeks gestational age. Thefirst and second pregnancy were both full term vaginal deliveries. The second baby had acongenital heartdefect. Patient arrivesona stretcher to thehigh-riskpregnancy (HRP) laborwardofanurbantertiaryhealthcarecenteratnoonwithcomplainsofsevereabdominalpainand leak per vagina since the night before. The patient is accompanied by her sister.

History:

Fivedaysago,patientvisitstheout-patientdepartmentofthesameurbantertiarycarecenterforherregularantenatalcheckup.Onexamination,herbloodpressurewasfoundtobe110/70,nopallor,edemanegativeandfetalheartsoundspositive.Estimateddeliverydate(EDD)givenwastwodaysago.Thedoctortoldherthatsincesheis2dayspastherduedate,sheshouldgetadmittedimmediatelytothecleanlaborward.

Thepatientwasnotyet inlabor.Fromherexperienceofherprevioustwopregnancieswhereshehadgone into laborafterherEDD, shedecidednot togetadmittedandwentbackhome.Fourdayslate,patientexperiencedseverelowerabdominalpain.Thepatientgoestothesametertiarycarecenterthenextmorning.

Dayofadmission:

PatientvisitstheOPDwhereherperabdominalexaminationwasdoneandnofetalheartsoundwasdetected.ThepatientissenttogetanultrasoundscanandreporttotheSepticRoomLaborWard(SRLW).Asthescanningroomisverycrowdedat thehospital, thepatient's familytakeheroutsidetoaprivatediagnosticcenterforscanningandreturn.ShegoestotheSepticRoomLaborWard(SRLW)asdirected.Fromtheresheissenttothecleanlaborward(CLW).AttheClean Labor Ward, they check her file and send her to the HRP labor ward in view ofintrauterine death (as seen in the scan). Patient is very tired and frustrated on arrival at theHRPatnoon.Patientsaysthatshecouldfeelthebaby'smovementssincethenightbefore.

OnarrivaltoHRP,BPwas150/110.Nopallor,noedema.


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At noon the membrane is artificially ruptured and meconium stained liquor is found. Thepatient is injected with oxytocin - 10 units intramuscular and 10 units intravenous. On pervaginal examination patient has dilated 6 cms. Labor is acceleratedwith oxytocin. One hourlater,patientdeliversafreshdeadfemalebabyweighing2.5Kgs.

CURRENTSCENARIO

Undetected(asymptomatic)fetaldistressinpregnantwomenpostterm.

Pregnant women currently monitor fetal health at home by maintaining a chart of fetalmovement through the day. This is inaccurate due to its subjective nature, especially inprimigravidae.Also,non-compliancebypregnantwomen is fairlycommon.There iscurrentlynomethod tomonitor the fetalheart rateathomeanddoctorsmonitor the fetusonlyduringroutinecheck-ups.

NEEDSTATEMENT

Anaccurate(Equal toNST)and lowskill (anypregnant femaleat termshouldbeable touse)waytodetectfetaldistressinwomenwhoarenotinlabor,usedathometoavoidIntrauterinefetaldeath(IUFD).

FILTERINGPROCESS

FinalScore=14

Rank=1

MARKETPOTENTIAL

Numberofdeliveriesannually:25,000,000

NumberofIUFDsandstillbirthsinthesystem:5,00,000

Thereareonanaverage40intrauterinefetaldeathsforevery1000livebirthsrecorded.

COMPETITIVELANDSCAPE

ThereiscurrentlynosolutionwithinIndiaavailabletodetectasymptomaticfetaldistressinahome setting. Hand held dopplers that are available, are recommended to be used only bytrainedclinicians.

InruralIndia,acomprehensivemotherandchildregistrationbookletcalledtheTHAYIcardisdistributed ward wise. Regular visits are made by Accredited Social Health Activists (ASHAworkers)tocheckmaternalandfetalhealth.Thesechecksincludereviewofthebabymovementchart.However, theworkersarenotprovidedwithhandhelddopplerstomeasurefetalheartrate and hence all pregnantwomenmust visit their nearest health care center for antenatalchecks.


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In urban India, there is a surplus of government, aided, charitable and private maternityhospitals,thoughnosolutionforaccuratehomemonitoringisavailable.EveninurbanIndia,thedaily baby movement chart is advised and is the only measure of fetal health from a homesetting.

ANon-StressTest(NST)andCTGareusedtomonitorwomeninearlyandactivelabour.AstateoftheartNSTmachinecostsaroundRs.3-4lakhs.

AVAILABLEOPTIONSFORFETALHEARTMONITORING

EXTERNALMONITORING

• Pinard Stethoscope - It is a gynecological instrumentwhich allows the heartbeat to beheardinaquickandeasymanner.ThePinardstethoscopeishelpfulwhenexpensivetoolssuchasultrasoundmachinesmaynotbeavailable.[2]

• ElectronicHand-HeldDoppler-monitoringthroughafetalDopplerissimilartothatofafetalstethoscope.AnadvantageoftheDopplerfetalmonitoroverafetalstethoscopeistheelectronicaudiooutput,whichplaysoutthefetalheartsoundthroughaninbuiltspeaker.

• ElectronicFetalHeartMonitors-Itkeepstrackoftheheartrateofthebaby(fetus).Italsochecksthedurationofthecontractionsoftheuterus.Theassociatedtestsarecalledanon-stress test and cardiotocography. Electronic monitors may be ultrasound devices orelectrocardiogramdevices.

INTERNALMONITORING

Fetal Scalp Electrode - For internalmonitoring, a sensor is strapped to the thigh.A thinwire(electrode)fromthesensorisputthroughthecervixintotheuterus.Theelectrodeisthenattachedtothebaby'sscalp.Thebaby'sheartbeatmaybeheardasabeepingsoundorprintedoutonachart.[3]

IDEALSOLUTION

Thesolutionmustbedesignedsuchthatitissimpletouseforapregnantwomanwithoutanyassistance. It must also be able to communicate the fetal heart rate in an understandablemethodtotheuser.Thesolutionmustalsogiveaccurateresultsthatarecomparableorbetterthantheexistingsolutions.

NEEDCRITERIA

MUSTHAVES

• Fetalheartrateoutputmustbeequaltoavailablesolutions• Audible/Visualoutputoffetalheartrate• Easytouseforanon-clinician• Non-invasive• Robustform


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NICETOHAVE

• Costeffectiveforeasieradoptioninruralsettings• Wire-free• Lightweight<200grams• Easytouseandstoreatahomesetting

REFERENCES

1. http://www.msdmanuals.com/home/women-s-health-issues/complications-of-labor-and-delivery/fetal-distress

2. http://www.blacksmithsurgical.com/gynecology-instruments/pinard-stethoscope3. https://myhealth.alberta.ca/Health/pages/conditions.aspx?hwid=hw214546


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2.UTERINEFIBROIDS-MONITORING

INTRODUCTION

Uterine fibroids are benign smooth muscle tumors of the uterus. Most women have nosymptoms while others may have painful or heavy periods. Diagnosis can be performed bypelvic examination or medical imaging. Medications of the gonadotropin releasing hormoneagonistclassmaydecrease thesizeof the fibroidsbutareexpensiveandassociatedwithsideeffects. If greater symptoms are present, surgery to remove the fibroid or uterus may help.Uterinefibroidsarethemostcommonreasonforsurgicalremovaloftheuterus.

OBSERVATION

32-year-old Female, from a rural area, with two prior pregnancies both of which were livedeliveries arrives at amajorurban tertiaryhealth center (THC)at theoutpatientdepartment(OPD), 8 months ago, with history of heavy menstrual bleeding and clots associated withabdominalpainsince thepast3months.Patientcomplainsofheavybleeding for15dayspermonthandchanges3-4sanitarypadsperday.

Theadvice fromthegynecologistat theOPDis toconductapelvicultrasoundscanandbloodworkof thepatient.The scan is conductedat the sameTHCandshowsa submucosaluterinefibroidofdimensions1.5x2centimeters(cm)alongwiththickeningoftheendometriallayeroftheuterus.Afterconsultingthescan,doctorsconcludethatthefibroidisstillsmallatthispointandaninvasiveremovalprocedurecanbeavoided.

Inordertomanagetheendometriallayerthickening,thepatientisadmittedintotheObstetricsandGynecology(OBGYN)wardatthehospital.Thepatientistransfusedwith2unitsofPackedRedBloodCells(PRBC)andaDilationandCurettage(D&C)procedure isdone.Patient issenthome and is counselled that the procedure done should control her heavy bleeding cycles.Patient is advised to get regular ultrasound scans done to continuously monitor thedevelopmentofthefibroid.

Patient 's bleedingwas in control for the next 6months. Thepatient goes to the local healthclinictogetanultrasoundscantomonitorthefibroidasperadvicebutthelocalclinicdoesnothave ultrasound equipment or a radiologist to conduct the scan. Since she is not facing anysymptoms and her heavy bleeding is in check she does not bothermuch about it. In the 7thmonth,thepatientexperiencesheavybloodflowandsevereabdominalpain.Sheimmediatelygoestothelocalclinicwheresheisreferredtogetanultrasoundscan.Forthescan,thepatientarrivesat theurbanTHCafter travellinga largedistance.Thescanshowsthat the fibroidhasgrownandis4.2cmx4.3cminsize.ShewasreferredtotheOBGYNwardforasurgery.

At the urban THC, patient is admitted and underwent a total abdominal hysterectomy undergeneral anesthesia (GA). The patient is in the fertile age group and has lost her ability toconceive.

CURRENTSCENARIO

Presently,uterinefibroidsinwomenarediagnosedwithanUltrasonography(USG)Scanwhenthewomanpresentswithsymptoms.Ifthefibroidissmall,itistreatedwithmedicationandthepatientisadvisedtogetregularscanstomonitorit.However,majorityofthehealthcentersinruralandsemiurbanpartsofIndiadonothaveUSGequipment.Somecenters,whichhavethe


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equipment,donothavearadiologistandhencecannotconducttheseregularscans.Duetothis,largenumberoffibroidcasesgounmonitoredandhavetobemanagedthroughahysterectomywhenthefibroidgrowstoolarge.

NEEDSTATEMENT

An accessible and low skill (without a radiologist, any doctor should be able to use) way tomonitor asymptomatic uterine fibroids in fertile women at primary healthcare centers topreventinfertilityandrisksofhysterectomy.

FILTERINGPROCESS

FinalScore=13

Rank=2

MARKETPOTENTIAL

Thereareanestimated20millioncasesofasymptomaticuterinefibroidsannually inIndia. [2]Approximately 10% of these patients have access to health centerswhere USG facilities andradiologistsareavailabletomonitor.Thisestimatesthepatientpooltoapproximately2millionpeopleannually.

Although Ultrasonography is an obvious solution to monitor fibroids, the absence of aradiologistinmostpartsofthecountrynullifiesitseffectiveness.Anotherissueofanultrasoundmachine in rural India is its use to determine the sex of the baby which is a step back incombating female infanticide in India. These two mutually exclusive factors present a largemarketforapossibledevicesolution.


Ultrasonography:Ultrasonographyisadiagnosticimagingtechniquebasedontheapplicationof ultrasound. [3]General Electric (GE)Healthcare is the gold standard forUSG equipment. InIndia,thecostofanUltrasoundMachinerangesfromINR250,000toINR3,000,000dependingon the brand and range of product. Another key factor in determining the price of USGequipmentisifitisfirsthandequipmentorcertifiedrefurbishedbyanauthorizeddealer.

Intheprivatehealthcaresetting,thecostofapelvicultrasoundscancanrangefromINR450toINR1,500dependinguponhealthcaresettingsuchasprivateclinicsortertiarycarecenters.

Magnetic Resonance Imaging (MRI):The cost of anMRIMachine in India ranges from INR10,000,000 to INR 70,000,000 depending upon the strength of magnetic field and brand.Certifiedrefurbished3Tesla(3T)MRIMachinescostanaverageofINR25,000,000.

TheaveragecostofanMRIScanintheprivatehealthcaresetting inIndiacanrangefromINR4,000toINR10,000.


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IDEALSOLUTIONSTATEMENT

Anidealsolutionshouldhavethefollowing:

• Ideally, the solution should be able to monitor the presence and growth of uterinefibroids at centers where an ultrasound machine, gynecologist or a radiologist isunavailable(accessibleandlowskill).

• It shouldbeable to indicatewhenauterine fibroidcanbe ignoredandwhen itneedsmanagement.

NEEDCRITERIA

MUSTHAVE

• UsablebyanGeneralPhysician• Lowcost:PatientshouldpaylessthanINR100persession

NICETOHAVE

• UsablebyNurseorparamedic• Indicatesexactdimensionsoffibroid• Indicateswhenfibroidscanbeignoredorwhenitrequiredsurgicalintervention

REFERENCES

1. "Uterinefibroidsfactsheet".OfficeonWomen'sHealth.January15,2015.Archivedfromtheoriginalon7July2015.Retrieved26June2015.

2. Asymptomatic Uterine Fibroids. (2018, 30 January). Retrieved fromhttp://www.sciencedirect.com/science/article/pii/S1521693408000205

3. Badea,R.;Ioanitescu,Simona(2012)."UltrasoundImagingofLiverTumors–CurrentClinicalApplications".

4. "MagneticResonance,acriticalpeer-reviewedintroduction".EuropeanMagneticResonanceForum.Retrieved17November2014.


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3.PREVENTIONOFSEIZURESINPRE-ECLAMPSIC/ECLAMPSICWOMEN

INTRODUCTION

Pre-eclampsia(PE)isadisorderofpregnancycharacterizedbytheonsetofhighbloodpressureandoftenasignificantamountofproteinintheurine.Whenitarises,theconditionbeginsafter20weeksofpregnancy.Inseverediseasetheremayberedbloodcellbreakdown,alowbloodplateletcount,impairedliverfunction,kidneydysfunction,swelling,shortnessofbreathduetofluidinthelungs,orvisualdisturbances.Pre-eclampsiaincreasestheriskofpooroutcomesforboth themother and the baby. If left untreated, itmay result in seizures atwhich point it isknownaseclampsia.[1]

OBSERVATION

18-Year-old female is 33+3weeks gestational age (33weeks and3 days into her pregnancy)andPrimigravida(Firstpregnancy).PatientarrivesattheOutPatientDepartment(OPD)atanurbanTertiaryHealthCentrewithpervaginalmildwhitedischargeandpelvicpain.Onfurtherquestioning,itisfoundthatherregularante-natal(pre-labor)check-upscanwasnotdone.Thepatient’s blood pressure is taken, BP 145/112 (High). Patient was advised to get admitted,howeverpatient’sfamilyisunwilling.Patientgoesbackhome.Twoweekslater,Patientcomesinto the emergency room at 5 a.m. with a history of 2 episodes of seizures. Her Family isunwilling to give a proper clinical history. On admission, her Pulse Rate (PR): 80, BloodPressure:130/100(high).Fetalheartsoundsnotlocalized.SheisdiagnosedwitheclampsiaandMgSO4 (Magnesium Sulphate) given according to Pritchard regimen (standard protocol forMagnesium Sulphate dosage). Prior to being treatedwithMagnesium Sulphate, patient is onLabetalol100mg(vasodilatingdrugusedtomanagehighbloodpressure)twiceaday(1-0-1).Whenshe isbeingmovedfromhighriskpregnancy(HRP)side-wardtoHRPLaborWard,shehadanotherepisodeof seizure.Uteruswas termsizedandrelaxed.PelvicScanrevealsSingleLiveIntra-UterineGestation(Fetuswasaliveinsidetheuterus)withCephalicpresentationandadequateLiquor.At6:40am,Patientisnotrespondingtooralcommands,veryirritable.PR:100,BP:120/70.Shehadatonguebiteovernight(Signofseizureovernight).ShehadpedalEdema(swelling due to accumulation of fluid (symptom of pre-eclampsia). At 2:30 pm, Labor wasinduced (current protocol to manage uncontrolled pre-eclampsia and eclampsia) and shedelivered(vaginally)afemaleat2kg(pre-term).At10am:Post-delivery,patientappearedweak.She fainted while being shifted from one bed to another. Patient was mildly anaemic.Immediatelyafterdelivery,babywasintheNeonatalICUforobservation,andthenshiftedoutwithin3-4hours.Post-deliverymaternalheartrate86,BP155/112(high).

CURRENTSCENARIO

Currently,managementofpre-eclampsiabeforetheonsetoflaborincludesclosemonitoringofmaternal and fetal status, medical management of hypertension through vasodilating drugssuch as labetalol and seizure prophylaxis with Magnesium Sulphate (which has risk ofMagnesium toxicity in the patient). However in large number of cases, delivery remains theultimatetreatmentwhichleadstoriskofseizurespre-Labor,duringLaborandpostLabor.


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NEEDSTATEMENT

An effective (MgSO4 fails to prevent seizures +Mg toxicity) way to prevent seizures in pre-eclampsic/eclampsicwomenatsecondarycarecentresandabovetopreventhighriskofbraindamageand/orMagnesiumtoxicity.

FILTERINGPROCESS

FinalScore=13

Rank=3

MARKETPOTENTIAL

Outof the30millionpregnanciesreportedannually in India (whichcome into thehealthcaresetting),thereare25millionreportedlivebirths.50outof1000livebirthshaveareportedcaseof pre-eclampsia progressing into eclampsia. As a result, there are 1.25 million cases ofeclampsiaandseizuresduringpregnancyannuallyinIndia.[2]

Currently there exists only one protocol tomanage pre-eclampsia and ultimate treatment inpremature medical termination of pregnancy and delivery. This possesses high risk to bothmotherandthebaby.Henceapotentialsolution,whichmayenablethepregnancytobecarriedtoterm,willhavealargepotentialmarket.

COMPETITIVELANDSCAPE-AVAILABLETREATMENTOPTIONS

MANAGEMENTOFBLOODPRESSURE(HYPERTENSION)

The World Health Organization (WHO) recommends that women with severe hypertensionduring pregnancy should receive treatment with anti-hypertensive agents. Labetalol,Hydralazine and Nifedipine are commonly used antihypertensive agents for hypertension inpregnancy.

Thegoaloftreatmentofseverehypertensioninpregnancyistopreventcardiovascular,kidney,andcerebrovascularcomplications.[3]

PREVENTIONOFECLAMPSIA

The intrapartum and postpartum administration of Magnesium Sulphate is recommended insevere pre-eclampsia for the prevention of eclampsia. Further, Magnesium Sulphate isrecommendedforthetreatmentofeclampsiaoverotheranticonvulsants.MagnesiumSulphateactsbyinteractingwithNMDAreceptors.[3]

INDUCTIONOFLABOR

Thedefinitivetreatmentforpre-eclampsiaisthedeliveryofthebabyandplacenta.Theseverityofdiseaseandthematurityofthebabyareprimaryconsiderations.Treatmentcanrangefromexpectant management to expedited delivery by induction of labor or Caesarian section, inadditiontomedications.[4]


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In the private healthcare setting in India, the overallmanagement of pre-eclampsia includinganti-hypertensive medication, Magnesium Sulphate, medical termination of pregnancy anddeliverycancostanywherebetweenINR25,000toINR80,000.



• Shouldbeabletomanagethebloodpressureeffectively• Avoidprogressionintoeclampsiaandseizures.

NEEDCRITERIA

MUSTHAVE

• ShouldcostasmuchorlesserpersessionuseascomparedtoMagnesiumSulphate.

NICETOHAVES

• Usablebyanurseorparamedic.• Allowpregnancytobecarriedtoterm.

REFERENCES

1. Pre-eclampsia: Symptoms, risks, treatment and prevention. (2018, January 30). Retrievedfromhttp://americanpregnancy.org/pregnancy-complications/preeclampsia/

2. P. N. Nobis, Anupama Hajong; “Eclampsia in India Through the Decades”, The Journal ofObstetricsandGynecologyofIndia,(September–October2016),66(S1):S172–S176

3. WHOrecommendationsforpreventionandtreatmentofpre-eclampsiaandeclampsia(PDF).2011.ISBN978-92-4-154833-5.Archived(PDF)fromtheoriginalon2015-05-13.

4. Steegers, Eric AP; von Dadelszen, Peter; Duvekot, Johannes J; Pijnenborg, Robert (August2010). "Pre-eclampsia".The Lancet.376(9741): 631–644.doi:10.1016/S0140-6736(10)60279-6.PMID20598363.


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4.UTERINEFIBROIDS-MANAGEMENT

INTRODUCTION

Uterine fibroids are benign smooth muscle tumors of the uterus. Most women have nosymptoms while others may have painful or heavy periods. Diagnosis can be performed bypelvic examination or medical imaging. Medications of the gonadotropin releasing hormoneagonistclassmaydecrease thesizeof the fibroidsbutareexpensiveandassociatedwithsideeffects. If greater symptoms are present, surgery to remove the fibroid or uterus may help.Uterinefibroidsarethemostcommonreasonforsurgicalremovaloftheuterus.[1]

OBSERVATION

32-year-old Female,who comes from a rural area,with twoprior pregnancies both ofwhichwere live deliveries arrives at a major urban tertiary health center (THC) at the outpatientdepartment(OPD),8monthsago,withhistoryofheavymenstrualbleedingandclotsassociatedwithabdominalpainsincethepast3months.Patientcomplainsofheavybleedingfor15dayspermonthandchanges3-4sanitarypadsperday.

Theadvice fromthegynecologistat theOPDis toconductapelvicultrasoundscanandbloodworkof thepatient.The scan is conductedat the sameTHCandshowsa submucosaluterinefibroidofdimensions1.5x2centimeters(cm)alongwiththickeningoftheendometriallayeroftheuterus.Afterconsultingthescan,doctorsconcludethatthefibroidisstillsmallatthispointandaninvasiveremovalprocedurecanbeavoided.

Inordertomanagetheendometriallayerthickening,thepatientisadmittedintotheObstetricsandGynecology(OBGYN)wardatthehospital.Thepatientistransfusedwith2unitsofPackedRedBloodCells(PRBC)andaDilationandCurettage(D&C)procedure isdone.Patient issenthome and is counselled that the procedure done should control her heavy bleeding cycles.Patient is advised to get regular ultrasound scans done to continuously monitor thedevelopmentofthefibroid.

Patient 's bleedingwas in control for the next 6months. Thepatient goes to the local healthclinictogetanultrasoundscantomonitorthefibroidasperadvicebutthelocalclinicdoesnothaveanultrasoundequipmentoraradiologisttoconductthescan.Sincesheisnotfacinganysymptoms and her heavy bleeding is in check she does not bothermuch about it. In the 7thmonth,thepatientexperiencesheavybloodflowandsevereabdominalpain.Sheimmediatelygoestothelocalclinicwheresheisreferredtogetanultrasoundscan.Forthescan,thepatientarrivesat theurbanTHCafter travellinga largedistance.Thescanshowsthat the fibroidhasgrownandis4.2cmx4.3cminsize.ShewasreferredtotheOBGYNwardforasurgery.

At the urban THC, patient is admitted and underwent a total abdominal hysterectomy undergeneral anesthesia (GA). The patient is in the fertile age group and has lost her ability toconceive.

CURRENTPROBLEM

Presently,uterinefibroidsinwomenarediagnosedwithanUltrasonography(USG)Scanwhenthewoman presentswith symptoms andmanaged by performing a hysterectomywhich is asurgery with high risk of post-operative complications and which also leads to infertility infertileagegroupwomen.Asafertreatmentoffibroidsislaparoscopicmyomectomywhichisan


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expensiveprocedurethatrequiredahighskilledsurgeonandhighresourceoperationtheatre.[2]

NEEDSTATEMENT

Asafer(uterussparingprocedure)andlowskill(anyobstetrician/gynecologistshouldbeabletoperform)waytomanageuterinefibroidsinwomenatsecondarycarehospitalsandabovetopreventrisksofhysterectomy.

FILTERINGPROCESS

FinalScore=12.5

Rank=4

MARKETPOTENTIAL

Atanygiven time in India,10%of the100millionwomen in fertileagegroupof20-35yearshaveuterinefibroids.Thataccountsforaprevalenceof10millioncasesoffibroids.Outofthese,anestimated10%ofwomenhaveaccesstoagynaecologist.Thisresultsinanpatientpoolof1millionwomeninthefertileagegroupalone.Outofthepost-menopausalagewomenwhohaveaccesstoagynaecologist,fibroidsareprevalentin1.5millionpatients.Thisaccountsforatotalofatleast2.5millioncasesoffibroidsinwomeninthepresenthealthcaresetting.[3][4]

The dearth of Laparoscopic equipment, OB-GYN surgeons trained in laparoscopy as well thehighcostsoflaparoscopicsurgeryareallfactorsinthelimitedprevalenceofmyomectomyasasolutiontomanagefibroids.This leaveshysterectomyastheonlysolution.Thehighrisksandlong recovery period of hysterectomy and the high costs of myomectomy are key factors inensurealargemarketpotentialforapossiblesolution.


Hysterectomy: Hysterectomy is the surgical removal of the uterus. Hysterectomy is apermanentsolutionforfibroids,andisanoptionifothertreatmentshavenotworkedorarenotappropriate. [5] In the private healthcare setting in India, the average cost of a hysterectomyrangesfromINR150,000toINR300,000.CharitabletrusthospitalschargeINR25,000toINR60,000fortheprocedureandgovernmenttertiarycarecentersdoitfreeofcharge.

Laparoscopic Myomectomy: Refers to the surgical removal of uterine fibroids usinglaparoscopic instruments. [5] Laparoscopic Myomectomy can cost anywhere between INR260,000toINR400,000intheprivatehealthcaresetting.

Medicinechoices:Gonadotropin-releasinghormoneanalogueisusedtoshrinkfibroidsbeforesurgery and to temporarily relieve symptoms. GnRH-a therapy puts the body in a statelikemenopause,whichshrinks theuterusand fibroids.GnRH-a therapy isused foronlya fewmonths,becauseitcanweakenthebones.Itmayalsocauseunpleasantmenopausalsymptoms.FibroidsgrowbackafterGnRH-atherapyisstopped.[5]


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• Managetheuterinefibroidwithoutremovingtheuterus• UsablebyanyOBGYNsurgeon• Inexpensive• Executableinalowresourceoperationtheatresetting

NEEDCRITERIA

MUSTHAVE

• UsablebyanyOBGYNsurgeon• Usableinlowresourceoperationtheatresettingsuchasadistricthospital• Shouldretaintheuterusirrespectiveofthesizeofthefibroid• ShouldcostthepatientlessthanINR150,000

NICETOHAVE:

• Non-Invasivemethod• Shouldbeabletobedoneunderlocalorspinalanesthesia• Usableinminoroperationtheatresetting

REFERENCES

1. "Uterinefibroidsfactsheet".OfficeonWomen'sHealth.January15,2015.Archivedfromtheoriginalon7July2015.Retrieved26June2015.

2. UterineFibroidTumors:DiagnosisandTreatment.(2018,January30).Retrievedfromhttp://www.msnbc.msn.com/id/39625809/ns/world_news-americas/

3. UterineFibroids:CurrentPerspectives.(2018,January30).Retrievedfromhttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC3914832/

4. Prevalenceoffibroids:astudyinasemiurbanareainTelangana,India.(2018,January30).Retrievedfromhttp://www.ijrcog.org/index.php/ijrcog/article/view/3899

5. UterineFibroids.(2018,January30).Retrievedfromhttps://www.mayoclinic.org/diseases-conditions/uterine-fibroids/diagnosis-treatment/drc-20354294


17

5.ECTOPICPREGNANCY

INTRODUCTION

EctopicPregnancy(EP) isacomplicationassociatedwithpregnancy,whereintheembryogetimplanted in the Fallopian Tube (most commonly) and starts growing there [1]. EctopicPregnancycanoccurintheovary,cervix,vagina,bodyoftheuterusorevenintheperitoneum.When the Embryo grows, the tube gets severely stretched leading to abdominal pain andvaginal bleeding. In many extreme cases, the tube ruptures leading to severe internal andvaginal bleeding. This is an emergency condition and requires quick surgical intervention topreventhemorrhagicshock.

OBSERVATION

32-year-old female,presented inher thirdpregnancyat8weeksand5daysofgestation.Herfirstpregnancyendedinanormalfull-termvaginaldelivery,whilehersecondpregnancyendedin an ovarian ectopic pregnancy leading to a unilateral Salpingo-Oophorectomy (removal oftubeandovary). Shehadcome intoanEmergencyUnit ina tertiary carehospitalwithheavyvaginalbleedingandsevereleftlowerabdominalpain.ShewasrushedtotheOperatingTheatre(OT) for a suspected ruptured tube/ovary. She is put under General Anesthesia (GA) and alowersegmentlaparotomywasperformed.Herovaryhadrupturedduetoanectopicpregnancygrowing on the ovary. A unilateral Salpingo-Oophorectomy was performed. The patient wasinfertile(sterile)duetoremovalofbothherovaries.Shewasunawareofherpregnancyfortwomonths.OvarianEctopicPregnanciesareextremelyrare.Morecommonly,thetuberupturesaretreated with a Salpingectomy. In addition, the woman cannot conceive normally if both thetubesareremoved.[2]

CURRENTPROBLEM

Early detection of Ectopic Pregnancy is extremely difficult especially sincemost pregnancies,especially in India are unplanned. Inmost of cases, females become aware of the pregnancyaround 6-8weeks of gestation. Awoman’s chances of fertility are severely reduced after thetubeisremovedononeside,andisreducedtozeroifbothtubesareremoved.

NEEDSTATEMENT

A safer (preserving tubal functionality) way tomanage tubal rupture (ectopic pregnancy) inwomenatsecondarycarehospitalsandabovetopreservethenormalfertilizationpathway.

FILTERINGPROCESS

Finalscore=11.5

Rank=5


18

MARKETPOTENTIAL

Annually, India has 4 recorded EPs per 1000 pregnancies. India has an estimated 30millionpregnanciesannually, implyingat least100,000annualcasesofEPs leading toSalpingectomyarerecordedinIndia.[3][4][5]


DIAGNOSIS

• β-HCG (Beta-Human Chorionic Gonadotropin) test: This hormone is produced in thebodyafter implantation.However, since the implantation isnotparticularlycomplete inatubal gestation, theHCG levels in the bloodmay not be high enough to be detected on aUrinePregnancyTest (UPT).Hence, false negatives are common. TheHCGblood test is amoredefinitivetestthanaUPT.ThecostisapproximatelyRs.600.

• Ultrasonography: A Transvaginal Ultrasound (TVS) is known to detect Tubal Pregnancywell(highspecificity).ItrangesfromRs.300toRs.2,000dependingonthescanningcenter.

DRUGTREATMENT

DrugtreatmentiseffectiveinmanagingEPsifitiscaughtearlyandthefetusisstillsmallinsize.Methotrexateisgivenasasingleshotorinregulardosestostoprapidlydividingcells.

MANAGEMENTOFRUPTUREDTUBE

LaparotomicorLaparoscopicSalpingectomyisinevitableoncethefetusismorethan5-7weeksofgestation.Laparoscopycanbeoptedforinnon-emergencysituations.[6]Thelowerendoftheprice range for the surgery would be Rs. 20,000 with costs going up to Rs. 50,000 in somecenters.


Anidealsolutionshouldbeabletostopthebleedingandremovealltheproductsofconceptionwithoutlosingtubalfunctionality.Thesolutionshouldstopthebleedingwithinamaximumofanhourofthepatiententeringthehealthcaresetting.

NEEDCRITERIA

MUSTHAVE

• Stopthebleedwithin60minutesofenteringthehospital• CanbeusedbyanyOBGYN• Shouldmaintaintubalfunctionality


19

NICETOHAVE

• Completelystopthebleedwithin30minutes• CanbeusedbyanyEmergencyDoctor• ShouldnotcostmorethanINR10,000tothepatient

REFERENCES

1. https://emedicine.medscape.com/article/2041923-overview2. https://docs.google.com/spreadsheets/d/1Qb7M3oeSCBmWIuhfQx7zHet5koks8pFXLB

8sgSwuFQA/edit?usp=sharing3. ArchanaMehta,ShehlaJamal,NeerjaGoel,MayuriAhuja,“Aretrospectivestudyof

ectopicpregnancyatatertiarycarecentre”,InternationalJournalofReproduction,Contraception,ObstetricsandGynecology,December2017,Volume6,Issue12,Page5241-5246

4. S.Tahmina,MaryDaniel,PreethySolomon,“ClinicalAnalysisofEctopicPregnanciesinaTertiaryCareCentreinSouthernIndia:ASix-YearRetrospectiveStudy”,JournalClinicalDiagnosticResearch,2016Oct;10(10):QC13–QC16

5. PritiSVyas,PratibhaVaidya,“Epidemiology,DiagnosisandManagementofEctopicPregnancy–Ananalysisof196cases”,BombayHospitalJournal

6. ElsonCJ,SalimR,PotdarN,ChettyM,RossJA,KirkEJonbehalfoftheRoyalCollegeofObstetriciansandGynecologists.Diagnosisandmanagementofectopicpregnancy.BJOG2016;.123:e15–e55


20

6.POSTPARTUMHEMORRHAGE

INTRODUCTION

PostpartumHemorrhage(PPH) isdefinedas the lossofmore than500mlofbloodwithin24hoursafterchildbirth(post2ndstageoflabour)[1].Thisisanemergencyscenariothatrequiresactiveinterventionofatrainedmidwifeorobstetrician.Iftoomuchbloodislost,thewomancangointohemorrhagicshock.

OBSERVATION

A 25-year-old femalewith a history of one normal vaginal full-term delivery, pregnant at 41weeksand1dayofgestationatthetime,wasadmittedfromtheOPDofatertiarycarecentretothe high-risk pregnancy labourwardwith highBlood Pressure(BP) of 140/100mmHg and apost-datedpregnancy.Thepatientwasnotinlabour.AurineAlbumintestindicated3+,andadiagnosisofPre-Eclampsiawasmade.ShehadnohistoryofPregnancyInducedHypertension(PIH) or any other comorbidities. She had done her regular Ante-natal Checkups (ANCs) aturbanprivateclinic.AnultrasoundshowedtheAmnioticFluidIndex(AFI)as4cm.Adecisionwas taken to induce labour using Intra-Venous Oxytocin and Dinoprostone Gel. The patientwentintolabourat1amanddeliveredalivefemalebabyof2kgsweightat10:25am.Placentawas completely expelled and all clots were removed. Uterus failed to contract and bleedingcontinued till 10:40 am. One more dose of Oxytocin and methergine was given. Bimanualcompression of the uterus along with fundal massage was performed. Bakri Balloon wasinsertedand inplaceat10:45am.At11am, thebleedingdidnot reduce.Non-pneumaticAnti-shock garments (NASG) were wrapped around lower limbs at 11:10am. Carbetocin andmisoprostolwasgiven,yetat11:30am,thepatientwasstillbleeding.Patient’sfamilywastoldto arrange 2 units of Packed Red Blood Cells (PRBCs). At 12:10pm, the patient was inhemorrhagic shock and had a weak pulse with heart rate of 130 bpm. Patient had lost anestimated 2 litres of blood. The bleed was slightly controlled with the Balloon, but had notstoppedcompletely.PatienthadstartedtodesaturatewithBloodOxygenSaturation(SpO2)of90%. A senior doctor took a decision to perform a Total Abdominal Hysterectomy (TAH) at12:30pm. Patient was transfused 4 units of PRBCs and blood products intra-op while underGeneral Anesthesia (GA). Patient was on a ventilator (Synchronous Intermittent MechanicalVentilator (SIMV)) support in the Intensive Care Unit (ICU). Patient was very weak and stillunresponsive24hours later.Her SpO2had risen to95%,Respiratory rate25/minandPulserate90/min.[2]

CURRENTPROBLEM

The inability tomanageaPostpartumHemorrhageover3hourswithuterotonicdrugs, bakriballoon tamponade and NASGs lead to a Total Abdominal Hysterectomy (TAH). An earlyhysterectomyhasseveralrisksassociatedsuchaslongrecoverytime,pelvicadhesions,vaginalprolapse,earlymenopauseetc.Inaddition,thewomanpermanentlylostherfertilityatanearlyageduetouterusremoval.


21

NEEDSTATEMENT

Aneffective(faster,lowskill,uterussparing,andaffordable-comparedtoembolization)waytomanage post-partum hemorrhage in women at Primary Health Centres and above to avoidhypovolemicshockandhighriskofmaternaldeath(whenhysterectomyisneitherpossiblenordesirable).

FILTERINGPROCESS

Finalscore=11

Rank=6

MARKETPOTENTIAL

5-8%ofdeliveriesendupinPPH.Thataccountsformorethan1millioncasesannually.Outofthese, atleast 1 in 10 cases (10%) cannot bemanaged by uterotonic drugs or Bakri BalloonTamponade. Annually, this leaves around 100,000 - 200,000mothers at high risk for severemorbidityormortality.[3][4]


Uterotonic/OxytocicDrugs:Oxytocin,ErgometrineandCarbetocinhelptheuterinemusclestocontract. They also increase the production of prostaglandins which in turn help in uterinecontraction.Misoprostolactsbybindingtomyometrial,leadingtocontractions.

Bi-manualUterinecompression:Fundalmassageandbimanualuterinecompressionhelpinmechanicallycompressingtheuterus.

UterineBalloonTamponade:Adeflateduterineballoon(mostcommonlyabakriballoon)isinserted into the uterus and inflated using sterile saline. These balloons normally have aminimum capacity of 500 ml. The tamponade action of the balloon pressing against themyometriumhelpsinstemmingbloodflow.Thecommerciallyavailableuterine-specificdevicesare designed with an intrauterine drainage port but have a prohibitively high cost. Lowresource settings have to rely on lower cost adaptations like a condom balloon tamponadewhichisthemostcost-effectivesecond-linemanagementoption.Successfulin92%ofcasesasasecondlineapproach.

Non-PneumaticAnti-ShockGarments(NASG):Thisinvolvescompressingandtyingthelimbsin a suitable cloth to reduce perfusion to the extremities. In this method, blood flow to thecriticalorgans(heart,brain,lungs,liverandkidneys)ismaintained.

AorticCompression:ThisisatechniqueusedwhilewaitingforOperatingRoomfacilities.Thedescendingaortaiscompressedattheumbilicusbyapplyingverticalcompressionintheformaclenched fist. Thepulse is checked at the femoral artery to ensure that aortic compression issuccessful(pulseshouldbeabsent).

Compression Uterine Suture (B-Lynch): This requires an obstetrician and OT facilities. Acoupleofsuturesareplacedthroughtheuterusinsuchaway(overthefundus),thattheentireuterusiscompressedmechanically.Thisisalaparotomicsurgery.


22

Uterine Artery Embolization: This surgery requires OT facilities and an interventionalradiologist(catheterizationlaboratory).Embolizingagentsaredeliveredintotheuterinearterywhilethepatientisundermildsedation.

PeripartumHysterectomy:Ifalltechniqueshavefailed,thelastresortistoremovetheuterus.This is a final and definitiveway to stop the bleeding. [5][6]The cost ranges fromRs. 50,000-200,000fortheprocedure.


Ideally,bleedingshouldbestoppedorsignificantlyreducedwithinonehourofonsetofthe3rdstageof labour (beginningof expulsionof placenta). The solution shouldbenon-surgical andshouldbeabletousedbyanydoctorortrainedmidwife(lowskill).

NEEDCRITERIA

MUSTHAVE

• Significantlyreducebleedwithin1hour• Canbeusedbyanydoctorormidwife• Non-surgicalmethod• CosttothepatientshouldbeunderINR2,000

NICETOHAVE

• Completelystopthebleedwithin1hour• Non-invasivemethod• CosttothepatientshouldbeunderINR1,000• Anytrainednurseshouldbeabletouse

REFERENCES

1. https://emedicine.medscape.com/article/275038-overview2. https://docs.google.com/spreadsheets/d/1Qb7M3oeSCBmWIuhfQx7zHet5koks8pFXLB

8sgSwuFQA/edit?usp=sharing3. Meliza CW Kong, William WK To, “Balloon Tamponade for Postpartum Hemorrhage:

caseseriesandliteraturereview”,HongKongMedJ2013;19:484-904. https://www.nhp.gov.in/disease/gynaecology-and-obstetrics/postpartum-

haemorrhage5. WHO Guidelines -

http://apps.who.int/iris/bitstream/10665/75411/1/9789241548502_eng.pdf6. http://www.icmr.nic.in/final/Final%20Pilot%20Report.pdf


23

7.NEONATALSEPSIS

INTRODUCTION

Neonatal sepsis is a blood infection that occurs in an infant younger than90daysold. Early-onsetsepsisisseeninthefirstweekoflifeandoccursafter1weekandbefore3monthsofage.It can be caused by bacteria such as Escherichia coli (E.coli), Listeria, and some strains ofstreptococcus.GroupBstreptococcus(GBS)hasbeenamajorcauseofneonatalsepsis.[1]

Neonatalsepsismaybecategorizedasearly-onsetorlate-onset.Ofnewbornswithearly-onsetsepsis, 85% present within 24 hours, 5% present at 24-48 hours, and a smaller percentagepresentwithin48-72hours.Onsetismostrapidinprematureneonates.[2]

OBSERVATION

23-year-oldPrimigravidacomplainsofabdominalpainat8months.

History:ScanshowsAFI19cmandfetalheartrate(FHR)154bpmatgestationalageof25+6weeks.Scanshowsmildrighthydroureteronephrosisandfetalheartrate136bpmatgestationalageof32weeks.

DayofOutPatientDepartment(OPD)visit:

Noon:Patientarrivesaturbantertiaryhealthcarecenter(THC)OPDwithacaseofabdominalpainandheadache since2days.HeartRate is120bpm.BloodPressure is170/100.Everythingelse isnormal. She is givenNifedipine 10mg and is advised admission to high risk pregnancy laborward (HRPLW). Patient’s family refuse admission as theywant her to get admitted to urbanTHCHospital#2which is incloserproximitytotheirresidence.TheurbanTHC#2refusestotakeherinandsheissentbacktourbanTHC#1.

Evening:Patient is admitted and is referred to a dermatologist in view of Pustular Lesions on theabdomen; and general medicine and psychiatry in view of breathlessness and psychosis.SystolicBloodPressurefluctuatingbetween150-160(althoughshewasonLabetalol).Caseofseverepre-eclampsia.MgSO4administeredaccording toPritchard’sregimen.Despite this, shehasaseizure.

Threedayslater:

ObstetricsscanshowsAmnioticFluidIndex(AFI)20cm,FHR142bpm,rightlateralventricleoffetus is1 cm in size andveryprominent.Bloodworkwasnormal.Twodays laterdelivery isinducedwith dinoprostone,misoprostol, foley’s catheter and artificial rupture ofmembranes(clearliquor).Sheisinducedpretermat35weeks.Shedeliversanalivebraindeadmalebabyof1.5 Kg the next day. This is inferred due to unnatural pupil dilatation. Baby doesn't cryimmediatelyafterbirth.ShiftedtoneonatalintensivecareunitNICU.Babycontractssepsisthefollowingday(babypronetosepsisduetopoorenvironmentalconditionintheNICU,aswellasunderweight andpre-termnatureof thebaby).Baby is indistress andoxygen saturationhasnotbeenmaintained.Babydoesnotrespondwelltosurfactant.Babyathighriskofdeathduetosepsis and lowbirthweight.Doctor claims that in a better equippedNICU (such as a privatehospital)thebabywouldnothavecontractedsepsisandwouldhaveahigherchanceofsurvival.


24

PROBLEMSTATEMENT

MgS04 treatment for the prevention of seizures in eclampsiawas ineffective. This led to thepatient’sconditionworsening intoeclampsia.As thepatientwas inriskdue toeclampsia, shewasinducedpreterm,thisputthebaby(pretermbaby)atrisk.Pretermbabiesareatagreaterrisk of getting sepsis due to their weaker immune system and underdeveloped lungs. NICUsmust initiate treatment for sepsis immediately on detection due to the relativeimmunosuppression of the neonate and also be equipped to treat for the overwhelmingsystemiceffectsofthedisease.

NEEDSTATEMENT

An affordableway to reduce the incidence of sepsis in neonates at primary care centers andabovetoavoidneonataldeath.

FILTERINGPROCESS

FinalScore=11

Rank=7

MARKETPOTENTIAL

Numberoflivebirthsannually:25,000,000

Numberofcasesofsepsisinthesystem:200,000

7neonatesper1000livebirthshaveSepsiswithinamonthofbirth.


Sepsis in neonates is treated in hospitals with a functioning NICU where they have a widevariety of staff on site, including neonatologists, neonatal nurses, and respiratory therapists.NICUcosttothepatientisaroundRs.15,000perday.

CURRENTTREATMENT

Early detection of sepsis - through early laboratory testing, Lumbar Puncture and CSFAnalysis,Radiography,CT,MRI,andUltrasonography.AntibioticTherapy -includescombinedIVaminoglycosideandexpanded-spectrumpenicillinantibiotictherapy.ConsiderationsforMeningitis-Infantswithbacterialmeningitisoftenrequiredifferentdosesofantibioticsandlongercoursesoftreatment.InvestigationalTherapies-Additionaltherapiesthathavebeeninvestigatedforthetreatmentof neonatal sepsis include Granulocyte transfusion, IVIg infusion, Exchange transfusion andRecombinantcytokineadministration.


25

Diet-Becauseofgastrointestinal(GI)symptoms,feedingintolerance,orpoorfeeding,itmaybenecessary to give the neonate nothing by mouth (nil per os; NPO) during the first days oftreatment.[3]


Thesolutionmustbeaffordableforuseinallruralandurbanprimarycaresettings.ItmustbeacceptableforuseincurrentNICUsandaddvaluetothecurrenttreatmentprotocol.Itshouldaid inprevention and/ormanagementof sepsis, taking into consideration all the touchpointsforpossiblesourceofinfection.

NEEDCRITERIA

MUSTHAVE

• Affordableforruralprimarycarecenters• AcceptabletouseinruraltertiarycareNICUs• Preventandmanage incidenceofsepsis in first24hoursofbirthORmanage late-onsetof

sepsis

NICETOHAVE

• Multi-functionalforverycrowdedNICUs(supportmorethanoneneonateatatime)

REFERENCES

1. Ref:https://medlineplus.gov/ency/article/007303.htm2. https://emedicine.medscape.com/article/978352-overview3. https://emedicine.medscape.com/article/978352-treatment


26

8.CERVICALCANCER

INTRODUCTION

Cervicalcancer isoneof the leadingcausesofcancermortality inIndia,whichaloneaccountsformorethan25%oftheworldwideburdenofcervicalcancers[1].Despitehighdiseaseburden,there is no nationwide government-screening program directed towards early detection ofcervicalcancer.Thisinturnenhancesincidenceofadvancedstagecancer.

OBSERVATION

A 54-year-old femalewith a history of 3 pregnancies, all ofwhich ended in normal full-termdeliveriescame into theOPDofaDistrictHospitalwithcomplaintsofheavyvaginalbleeding.Shehadextremelypainfullowerabdominalpain,especiallyduringherperiodsandwouldpassseveralclots.Shehadnormalbleedinguntil6monthsago,whenherbleedingbegantoincreasesignificantly along with increased abdominal pain. Prior to this, she had no knowncomorbidities.Shealsocomplainedofdyspareuniaandconstipation.Shewasseverelyanemicand was transfused with 2 unites of Packed Red Blood Cells (PRBCs). On per speculumexamination, a large cervicalmasswas found.ACT scan revealed a9 x9 cmmasswithmilkhydronephrosis.Thebiopsyrevealedawell-differentiatedcarcinomaatIIIBstage.Shereceiveddailypelvic radiation therapy.Over fewdaysof treatment, thebleedinghad reducedandherstomach pain was no longer present. However, the patient keeps complaining of increasedoverallfatigueandsevereshortnessofbreath.Thepatientispermanentlyunderpalliativecare.[2]

CURRENTPROBLEM

In India,delayedpresentationandthusdiagnosisofcervicalcancercasesaddhugeburdenofmortality(approximately132,000newcasesdiagnosedand74,000livesclaimedannually). [3]In a country where healthcare expenses are largely borne by the patient and no screeningprogramsarerunforanearlydetectionofcervicalcancer,asolutionwhichcanintroducehighcompliancetoearlyscreeningwouldberequiredtodetectcervicalcancercasesininitialstages.

NEEDSTATEMENT

Anaccurate(comparedtoapap-smear)andlowskill(anydoctorshouldbeabletouse)waytodetectcervicalcancerinwomenatprimaryhealthcarecenterstoreducetheincidenceoffalsenegativesandlatediagnosis.

FILTERINGPROCESS

Finalscore=9

Rank=8

MARKETPOTENTIAL

CervicalcancerinIndiaisveryprevalentandapproximately132,000newcasesarediagnosedperyearwith74,000deathsannuallyreportedduetocervicalcancer,accountingformorethan


27

1/4oftheglobalcervicalcancerdeaths.Indianwomenfacea2.5%cumulativelifetimeriskand1.4%cumulativedeathriskfromcervicalcancer.


The Pap (Papanicolaou) Test- In this test, the cells are gently scraped from the outside ofcervixandvaginabythedoctorfortesting.TraditionalPaptestscanbehardtointerpretasthecells can dry out, but Improved Pap test methods have made it easier for doctors to findcancerous cells. Recently, the liquid-based cytology tests, often referred to as ThinPrep orSurePath,transferringathinlayerofcellsontoaslideafterremovingbloodormucusfromthesample,havebeenused.[4]Thesampleispreserved,soothertestscanbeperformedatthesametime, such as the HPV test.Computer screening, often called AutoPap or Focal Point, uses acomputer to scan the sample for abnormal cells. Cost of a Pap smear test topatient couldbebetween INR 200 – 1,500, depending upon in which area of the country the test is beingperformed.

HumanPapillomaVirus(HPV)DNATest-AnHPVtestisperformedonasampleofcellsfrompatient’scervixanditissimilartoaPaptest.ItisusuallyperformedwiththePaptestorafterPaptestresultsshowabnormalchangesinpatient’scervix.ManywomenhaveHPV,butdonothavecervicalcancer.NewgenerationofHPVDNAassayscombinesqualitativedetectionof12high-risk HPV genotypeswith HPV-16 and HPV-18 genotyping.[5]HPV testing alone is not anaccuratetestforcervicalcancer.ItcancostbetweenINR2,000-7,000inIndiansettings.

Endocervical Curettage or Cone Biopsy with Cytology- Endocervical Curettage (ECC) isperformedwhenthedoctorwantstocheckanareainsidetheopeningofthecervixthatisnotvisibleduringacolonoscopy.Inthisprocedure,toscrapeasmallamountoftissuefrominsidethecervicalopening,doctorsuseasmall,spoon-shapedinstrumentcalledacurette.Conization(aconebiopsy)removesacone-shapedpieceoftissuefromthecervix.Conizationmaybedoneas treatment toremoveapre-canceroranearly-stagecancer. It cancostbetween INR2,000-10,000inIndiansettings.

Imaging techniques to visualize tumor size- CT scan or MRI scan scan can be used tomeasurethetumor’ssize,oncetheabovestatedtestsshowpositiveresults.ACTmachinecancost INR50Lakh-1.5CroreinIndiansettingsdependinguponwhichversionsarebeingusedandperscan,theamountchargedtopatientcanvaryfromRs.3000-8000.AnMRImachinecancostbetweenINR1.5-2.5CroreandperscancosttopatientcanbeanywherebetweenINR1,500–25,000,dependinguponthebodypartbeingtestedandtheareainwhichthetestisconducted.


Ideally, the solution should be able to detect early stage cervical cancerwith high fidelity. Itshouldbeverylowcost,withanabilitytoenhancecomplianceamongstwomentowardsregularscreeningforcervicalcancer.Thesolutionshouldbenon-surgicalandeasilyinterpretable.


28

NEEDCRITERIA

MUSTHAVE:

• Abilitytodiagnosecervicalcancerinearly-stage• Highportability• Easytointerpret• Minimalfalse-positiveandfalse-negativerate• Non-surgicalmethod• CosttothepatientshouldbeunderINR1000

NICETOHAVE:

• Non-invasivemethod• Anytrainedtechnicianshouldbeabletoperformthetest• CosttothepatientunderINR500

REFERENCES

1. Bobdey, S., Sathwara, J., Jain, A., & Balasubramaniam, G. (2016). Burden of cervicalcancerandroleofscreeninginIndia.Indianjournalofmedicalandpaediatriconcology:officialjournalofIndianSocietyofMedical&PaediatricOncology,37(4),278.

2. https://docs.google.com/spreadsheets/d/1Qb7M3oeSCBmWIuhfQx7zHet5koks8pFXLB8sgSwuFQA/edit?usp=sharing

3. WHO/ICO Information Centre onHPV and Cervical Cancer (HPV Information Centre).SummaryreportonHPVandcervicalcancerstatisticsinIndia2007.

4. https://www.cancer.net/cancer-types/cervical-cancer/diagnosis5. Vince, A., & Lepej, S. Ž. (2010). Diagnosticmethods and techniques in cervical cancer

preventionPartII:MoleculardiagnosticsofHPVinfection.MedicinskiGlasnik,7(1).


29

9.SURGICALSITEINFECTIONS

INTRODUCTION

Anysurgerythatcausesabreakintheskincanleadtoaninfection.TheseinfectionsareSurgicalSiteInfections(SSIs)becausetheyoccuronthepartofthebodywherethesurgerytookplace.AnSSItypicallyoccurswithin30daysaftersurgery.3typesofsurgicalsiteinfections:

1. Superficial Incisional SSI. This infection occurs just in the area of the skin where theincisionwasmade.

2. Deep Incisional SSI. This infection occurs beneath the incision area in muscle and thetissuessurroundingthemuscles.

3. Organ or Space SSI.This typeof infectioncanbe inanyareaof thebodyother thanskin,muscle,andsurroundingtissuethatwasinvolvedinthesurgery.Thisincludesabodyorganoraspacebetweenorgans.[1]

OBSERVATION

Female,23-year-old,senttotheminoroperationtheaterofanurbantertiaryhealthcarecenter(THC)with an infection on her lower segment Caesarean Section (LSCS) incision site. She iscurrentlyonpost-operativeday3.

At theMinorOT:Suture is removedusingapairof tweezersandwithoutadministering localanesthesia.InfectedpusiscleanedoutusingHydrogenPeroxide.Anantisepticisappliedtothewound.Remainingpusandthedeadcellsareremovedusingablade.Thewoundisdressed.Thewoundhastohealforaweeksothatnewcellswouldgenerate(granulationtissue).Afterthis,are-suturingwill be done. Patientwill need to remain in theward for at least aweek for thewoundtohealandforre-suturing.

PROBLEMSTATEMENT

Infections are causedbybacteria that enter the surgicalwound throughvarious touchpointssuchasfromcontactofthecaregiver,surgicalinstrumentcontamination,airandenvironmentor through germs already in the body. SSI is a major cause of morbidity in post-operativeprocedures and also leads to prolonged hospitalization, re-suturing and incurred costs ofservices.

NEEDSTATEMENT

A better (current way causes infections) way to prevent Suture Site Infections in openabdominal/pelvic surgeries at DistrictHospitals andTertiaryHealthcare Centers to avoid re-suturingofincisionandriskofsepsis.

FILTERINGPROCESS

FinalScore=8

Rank=9


30

MARKETPOTENTIAL

Numberoflivebirthsannually:25,000,000

TotalnumberofSSIcasesfromC-sectionoperationsannually:200,000(40per1000C-sections.1in5deliveriesareC-sections.)

Totalnumberoflaparotomyproceduresannually:10,000,00


The number of variables that can influence SSI rates is large. Preoperative planning andintraoperative technique become important in prevention of SSI. In addition, the appropriateuse of preventive antibiotics in an appropriate fashion is very important. C-sections cost thepatient upto Rs. 1 lakh based on the hospital. Costs of all precautionary and preventivemeasurestakenareincludedinthetotalcost.

PreoperativePlanning-Thesiteofthesurgicalincisionshouldbemanagedpriortotheactualarrivalofthepatientintheoperationtheater.Manysurgeonsinstructtheirpatientstoshowerandscrubthesurgicalsitewithantisepticsoapontheeveningpriortotheprocedure.Also,thesiteoftheplannedincisionshouldnotbeshavedorclippedtheeveningbeforetheoperation.Prevention of SSI in the operation theater - Prevention in the OR begins with the skinpreparation of the operative site. The site is cleansedwith chlorhexidine or povidone iodine.Prevention also requires the use of caps, gowns, masks, and sterile surgical gloves. Doubleglovingisalsorecommended.PreventiveAntibioticTherapy-Theantibioticshouldbeadministeredpreoperatively,butasclose to the time of the incision as is clinically practical; antibiotics should be administeredbeforeinductionofanesthesiainmostsituations.Increased Oxygen Delivery - Experimental evidencehas favored the concept that increasedoxygendeliveryhasafavorableinfluenceinthepreventionofinfection.Optimizing Core Body Temperature -Better intraoperativeandpostoperative temperaturecontrolofthepatientmayreducetheriskofSSI.BloodGlucoseControl-BettercontrolofbloodglucoseappearstohavevalueinthereductionofSSI.[2]


The solution must aim to measurably reduce the incidence of SSI in open abdominal/pelvicsurgeriesdoneruralandurbandistricthospitalsandabove.


31

NEEDCRITERIA

MUSTHAVE

• Betterthancurrentsolutions• Acceptableforuseinruralandurbandistricthospitals

NICETOHAVE

• Lowcostimplementation• Non-invasive

REFERENCES

1. https://www.hopkinsmedicine.org/healthlibrary/conditions/surgical_care/surgical_site_infections_134,144

2. https://www.medscape.org/viewarticle/448981_6


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10.PLACENTALABRUPTION

INTRODUCTION

Placental Abruption is a condition when the placenta separates from the uterus beforechildbirth.Thisisadangerousconditionwherethefetusissuppliedlesserbloodthanrequired.This can lead to severe fetal morbidity and even death. Common risk factors includeHypertensive Disease of Pregnancy (HDP), physical trauma, short umbilical cord, prolongedruptureofmembranesetc.[1]

OBSERVATION

A28-year-oldfemaleat31weeksand5daysofgestationalage,withhistoryofonenormalfull-termvaginaldelivery,wenttoaPrimaryHealthCentre(PHC)complainingofseverelowerbackpain.Shewasreferred toaTalukHospitalwhereshewasasked togetascandoneandcomewith the report 3 days later. On the 3rd daymorning, she did not feel any fetal movements.PatientexperiencedheavybleedingandgoesbacktotheTalukHospital,whereshewasaskedtoimmediatelygotoagovernmentTertiarycarecentreduetoasuspectedplacentalabruption.

In theurbanhospital, on examination, shehadpositivepallor andbilateral pedal edema. Shewasshiftedtothehigh-riskpregnancylabourwardat11am.Atleast150gramsofclottedbloodwasremovedvaginally,amountingtoabloodlossof600ml.Thepatient’sfamilywasaskedtoarrangeforPackedRedBloodCells(PRBCs)fromthebloodbank.At12noon,aNon-StressTest(NST)was done and good fetal heart soundswere detectedwith a FetalHeart-rate (FHR) of140/min. Doctor decided to induce labour (terminate the pregnancy) since the extent ofabruptionwastoosevere.Membraneswererupturedartificiallyandblood-stainedliquorwasobserved.AnimmediateC-Sectionwasplanned,provided2unitsofPRBCsweremadeavailable.Bloodwas not available at 2 blood banks as of 5pm. Themother had progressed to stage 2Hypovolemicshockwithaheart-rateof110/min.Therewaslessthan300mlurineoutputover12hours.Meanwhile,thepatientprogressedintolabouranddeliveredafemalebabyofweight1.5kgsat6pm.Thebabywasnotbreathing.Shewasventilatedonambu-bagandshiftedtotheNeonatal Intensivecareunit (NICU).Thepediatriciandiagnosed thebabyas severelyhypoxicwithabloodoxygensaturation(SpO2)of85%.Babywasintubatedandputonaventilator.Thedoctor said the delay in arranging of blood resulted in the babybeing asphyxiated.At 10pm,bloodwasarrangedforandtransfused.Themotherwasoutofdangerposttransfusion.[2]

CURRENTSCENARIO

ThedelayinarrangingbloodfromthebloodbankduetounavailabilityofbloodledtothedelayinperformingtheCesareanSection.Thisledtothefetusbeinghypoxicwhichleadtoasphyxia.

NEEDSTATEMENT

An accessible and affordable way to manage placental abruptions in women when blood isunavailable,atDistrictHospitalsandabovetopreventhypovolemicshockandfetalasphyxia.


33

FILTERINGPROCESS

Finalscore=8

Rank=10

MARKETPOTENTIAL

Annually,Indiahasaround10recordedPlacentalAbruptionsper1000livebirths.Indiahasanestimated 25 million deliveries annually. This implies that India has atleast 250,000 annualcasesofPlacental abruptions. Currently, India falls short by10%on availability of blood andblood products. Hence, we can estimate around 25,000 annual cases of placental abruptionswherebloodisunavailable.


DifferentialDiagnosistoconfirmplacentalabruptionvsplacentaprevia(iftimepermits).

Blood tests to check blood clotting parameters, Liver Function Tests (LFTs), Renal FunctionTests(RFTs),SerumUreaandElectrolytesetc.

Thestandardguidelinesforasevereplacentalabruption(hypovolemicshock)istodeliverthebabyas soonaspossible viaLowerSegmentC-Section (LSCS)while transfusingbloodpre-opand intra-op. [3][4][5]CostofPackedRedBloodCells(PRBCs) isaroundRs.200-1000perunit.LSCScancostuptoRs.1lakh.


Anidealsolutionshouldbeabletodeliverthebabyassoonaspossiblewhenbloodandbloodproductsarenotavailablefortransfusion.Thesolutionshouldbeusablebyanynurse.Itshouldbe inexpensive to the patient. Expensive solutions exist for autologous blood transfusions.Theseneedtobemadeaffordable.

NEEDCRITERIA

MUSTHAVE

• Easytouse(anynurse)• LessthanINR2,000costtopatient• ShouldenableimmediateCesareanSection• Shouldrestorebloodparameters(volume,WBCs,platelets,hematocrit)toanadequate

levelwithin1hour(Hb>10gms/dL)


34

NICETOHAVES

• LessthanINR1,000costtopatient• Should restorenormalbloodparameters (volume,WBCs,platelets,hematocrit)within

30-45minutes(Hb>12gms/dL)• PortableSolution

REFERENCES

1. https://emedicine.medscape.com/article/252810-overview2. https://docs.google.com/spreadsheets/d/1Qb7M3oeSCBmWIuhfQx7zHet5koks8pFXLB8sg

SwuFQA/edit?usp=sharing3. SubhaSivagamiSengodan,MohanaDhanapal,“Abruptioplacenta:aretrospectivestudyon

maternalandperinataloutcome”,InternationalJournalofReproduction,Contraception,ObstetricsandGynecology,October2017,Volume6,Issue10,Page4389-4392

4. VARTIKASHRIVASTAVA,PUSHPAKOTUR,ABHINAVJAUHARI,“MaternalandfetaloutcomeamongabruptioplacentaecasesataruraltertiaryhospitalinKarnataka,India:aretrospectiveanalysis”,INTERNATIONALJOURNALOFRESEARCHINMEDICALSCIENCES,October-December2014,Vol2,Issue4,Page1655-1658

5. RCOGGuidelines-https://www.rcog.org.uk/globalassets/documents/guidelines/gtg_63.pdf