Screening and Early Detection of Preeclampsia

Harshad Sanghvi Vice-President Innovations, Medical Director

Asia Region Meeting: Making every mother and baby count Dhaka, May 2012

Definitions
Preeclampsia: Hypertension, proteinuria in pregnancy
Mild: Diastolic 90-100, proteinuria1-2g/l

Severe: diastolic 110+, proteinuria 3g/l

Eclampsia: +convulsions

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

Understanding
To eliminate preventable eclampsia, we need to detect all the preeclampsia that there is and so we need to do a BP and protein test periodically in women whether they can come to clinics or not No amount of improvement in facility PEE detection will detect all the PE.

Prediction of Preeclampsia
Risk factors not very useful No effective or affordable biochemical or biophysical predictor available after exploring almost 40 approaches

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

Massive unmet need for early detection of PE Source DHS

Country
Bangladesh Bolivia DRC India Indonesia Kenya Malawi Mozambique Nepal Zimbabwe

% Unmet need for BP Check

53.1% 24.5% 38.8% 52.5% 13.9% 22.8% 28.6% 48.7% 43.8% 14.0%

% Unmet need for Proteinuria Check

70.5% 50.9% 57.8% 56.8% 63.0% 38.9% 81.3% 73.9% 77.7% 39.8%
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SBMR: Nepal Experience in improving quality of PEE care

Intervention: 1 day on site whole facility orientation by NESOG Review of standards, practice of skills Baseline assessment, gap analysis, action plan Re-assess at 2, 4 months facility Reached Lots of phone follow up standard in 6 Baseline 2 4 months months months % facilities meeting standards % facilities where no standard met 14% 27% 36% 0% 59% 0%
SBA training sites MOH Hosp Private hospitals Med school PHCC 87%

50% 17% 38% 33%

Average score

26%

60%

63%

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 limited resources available Limited awareness of the problems associated with conventional blood pressure measurement techniques; Aneroid BP machines require frequent recalibration about 45% of all machines tested in one study were off by 15mm diastolic

Specifications for a Hypertension detector for community use

Functional Requirements
Utilizes systolic and diastolic BP On-site calibration

Environmental Factors

Water /dust resistant Shock resistant Rechargeable energy source

Portable, low weight

Human Factors
Binary output

And:
Low cost

Culturally acceptable exterior,

Low complexity
Simple instructions Minimal moving parts Long lasting ( 3 Years)

suited for use by non literate providers

Early prototypes

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 suitable for 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

Environmental Factors
Robust Stays accurate in harsh

Human Factors
Binary output, easy to

environmental conditions
AND Very low cost Low complexity Simple instructions

interpret
Avoid urine collection in

bottle
Culturally appropriate

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Development Teams
Peter Truskey, Maxim Budyansky, Sean Monagle, James Waring, Matthew Means, Sherri Hall, Mary OGrady, Shishira Nagesh

2010-11 2010-11

2009-10

Benjamin Yoo, Thembi Mdluli, Millie Shah, Sean Monagle, Stephen Dria, Ezra Taylor,Elisa No, Elaine Yang, Britni Crocker, Jackie Birkness

How can we detect all the Preeclampsia before it becomes life threatening
Take testing for hypertension and proteinuria to women in their homes
Reagent modified to yield sharp color change when there is 0.3g/l protein: The test strip prepared by marking an end of a piece of filter paper with the reagent. Use: Pregnant woman who is instructed to void urine on the test area of the strip and report if a color change from yellow to blue occurs.

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Frugal Engineering
Normal Threading Reverse Threading

Screws, Bottle Caps Righty Tighty, Lefty Loosey

Most people assume cap is sealed and cant be opened

Validation of POC test in ANC Clients, Rural Nepal

Compared to Esbach (>.30 vs. <.30)

Sensitivity Specificity PPV NPV

POC (N=578) Point Estimate and 95% CI 93.9 (79.8, 99.3)

76.0 (72.1, 79.5) 19.1 (13.4, 26.0) 99.5 (98.3, 99.9)

Dipstick (N=578)
48.5 89.5 21.9 96.6

Esbach test is the qualitative standard, Dipstick test is the standard of care (trace or 1+ vs. negative); Point of Care (POC) self-test is new

Sanghvi, Monagle, Sharma 2011

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