Sanghvi_Screening and Early Detection of PEE

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    Screening and Early Detection ofPreeclampsia

    Harshad Sanghvi

    Vice-President Innovations, Medical Director

    Asia Region Meeting: Making every mother and baby count

    Dhaka, May 2012

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    Definitions

    Preeclampsia: Hypertension, proteinuria inpregnancy

    Mild: Diastolic 90-100, proteinuria1-2g/l

    Severe: diastolic 110+, proteinuria 3g/l Eclampsia: +convulsions

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    Preeclampsia: The Knowledge

    Preeclampsia is the second biggest

    killer of women and babies

    All preeclampsia is detectable by doing

    a blood pressure and protein test

    periodically in pregnancy We have had that evidence for 50+

    years

    More than 50% of women worldwide do

    not get a minimum of 4 ANC visits

    Much more than 50% of women do not

    get both a BP test and protein test

    If we do not detect preeclampsia, we

    will eventually find out when women get

    Eclampsia

    Maternal Mortality Map of the World

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    Understanding

    To eliminate preventable eclampsia, we need to detect allthe preeclampsia that there is and so we need to do a BPand protein test periodically in women whether they can

    come to clinics or notNo amount of improvement in facility PEE detection willdetect all the PE.

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    Prediction of Preeclampsia

    Risk factors not very useful

    No effective or affordable biochemical or

    biophysical predictor available after exploringalmost 40 approaches

    Implication: All pregnant women are potentially at riskneed prevention as well as early detection of PE

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    Massive unmet need for early detection ofPE Source DHS

    Country % Unmet need for BPCheck

    % Unmet need forProteinuria Check

    Bangladesh 53.1% 70.5%

    Bolivia 24.5% 50.9%

    DRC 38.8% 57.8%

    India 52.5% 56.8%

    Indonesia 13.9% 63.0%

    Kenya 22.8% 38.9%

    Malawi 28.6% 81.3%Mozambique 48.7% 73.9%

    Nepal 43.8% 77.7%

    Zimbabwe 14.0% 39.8%

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    SBMR: Nepal Experience in improvingquality of PEE care

    Intervention: 1 day on site whole facility orientation byNESOG

    Review of standards, practice of skills

    Baseline assessment, gap analysis, action plan

    Re-assess at 2, 4 months

    Lots of phone follow up

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    Baseline 2months

    4 months

    % facilities meetingstandards

    14% 36% 59%

    % facilities whereno standard met

    27% 0% 0%

    Average score 26% 60% 63%

    facility Reachedstandardin 6months

    SBAtrainingsites

    87%

    MOHHosp

    50%

    Privatehospitals

    17%

    Medschool

    38%

    PHCC 33%

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    Some issues with measuring BP

    Significant training needed to do BP well

    Equipment failure: The frequent marketing of non-validated blood pressure measuring

    devices that do not work for long

    The relatively high cost of blood pressure devices given the limitedresources available

    Limited awareness of the problems associated with conventionalblood pressure measurement techniques;

    Aneroid BP machines require frequent recalibration

    about 45% of all machines tested in one study were off by15mm diastolic

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    Specifications for a Hypertension detector forcommunity use

    Functional Requirements

    Utilizes systolic and diastolic BP

    On-site calibration

    Portable, low weightHuman Factors

    Binary output

    Culturally acceptable exterior,

    suited for use by non literateproviders

    Environmental Factors

    Water /dust resistant

    Shock resistant

    Rechargeable energy source

    And:

    Low cost

    Low complexity

    Simple instructions Minimal moving parts

    Long lasting ( 3 Years)

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    Early prototypes

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    Community Hypertension Detector

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    Testing for proteinuria

    Urine dipstick tests quite pricey: Test reagent is not what makes it pricy.

    Difficult to void urine on the reagent area, so need collection in bottle

    Much user variability in interpreting graded color change

    Boiling not feasible in high-volume sites, not suitablefor home testing

    Esbach takes 24 hours and is quite complex

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    Specifications for a community urine protein test

    Functional Requirements

    As accurate as dipstick

    Minimal steps required

    Human Factors Binary output, easy to

    interpret

    Avoid urine collection in

    bottle

    Culturally appropriate

    Environmental Factors

    Robust

    Stays accurate in harsh

    environmental conditions

    AND

    Very low cost

    Low complexity

    Simple instructions

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    Benjamin Yoo, Thembi Mdluli, Millie Shah,

    Sean Monagle, Stephen Dria, Ezra Taylor,Elisa

    No, Elaine Yang, Britni Crocker, Jackie Birkness

    Peter Truskey, Maxim Budyansky, Sean

    Monagle, James Waring, Matthew Means, Sherri

    Hall, Mary OGrady, Shishira Nagesh

    2010-11

    Development Teams

    2009-10

    2010-11

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    How can we detect all the Preeclampsiabefore it becomes life threatening

    Take testing for hypertension and proteinuria to womenin their homes

    Reagent modified to yield sharpcolor change when there is 0.3g/l

    protein: The test strip prepared by

    marking an end of a piece of filterpaper with the reagent.

    Use: Pregnant woman who is

    instructed to void urine on thetest area of the strip and report ifa color change from yellow toblue occurs.

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    Screws, Bottle Caps

    Righty Tighty, Lefty Loosey

    Normal Threading Reverse Threading

    Most people assume cap is

    sealed and cant be opened

    Frugal Engineering

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    Validation of POC test in ANC Clients,Rural Nepal

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    Compared to Esbach (>.30 vs.

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