Development and pilot an automated Pregnancy and Birth Registry

Kara Wools-Kaloustian M.D. M.S.Kara Wools-Kaloustian M.D. M.S.

pMTCT Cascade

All women presenting for delivery

HIV infected women only

EM Stringer. Bulletin of the World Health Organization. January 2008, 86 (1)

Questions Arising in pMTCT• What is the impact of maternal pMTCT on:

– Birth outcomes– Infant growth and development– HIV- infected children’s response to ART

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InfantOutcomes

Maternal Data Sources and Points of Data Loss

No standard collection system

ANC Number not uniqueData Not Electronically CapturedAggregate Data Reported to MOH

pMTCT Number not uniqueData Not Electronically CapturedAggregate Data Reported to MOH

Number not uniqueData Not Electronically CapturedAggregate Data Reported to MOHMin. dataset collected variable

Patient loss prior to enrollment Infant identifiers not collected on

maternal forms

Pediatric Data Sources and Points of Data Loss

Number not uniqueData Not Electronically CapturedAggregate Data Reported to MOHMin. dataset collected variable

No linkage with HIV dataData Not Electronically CapturedAggregate Data Reported to MOH

Patient loss prior to enrollment Maternal Identifiers not collected on infant

forms

Data Linkages Required to Assess Impact of pMTCT on Pediatric response to ART

Feasibility of A Medicines in Pregnancy Registry

• Nearly 90% of the data currently being advocated for collection in the WHO’s “Pilot Study to Assess the Feasibility of a Medicines in Pregnancy Registry” through the Pregnancy Outcome CRF are currently collected as part of routine care within the USAID-AMPATH Program.

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Objective

• O1: Develop and pilot an automated Pregnancy and Birth Registry within the OpenMRS and assess feasibility of transferring this registry to another openMRS-based records system

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Hypotheses

• H1a: An automated pregnancy and birth registry can be developed within OpenMRS, linking maternal and infant data allowing for a more complete assessment of impact of ART on pregnant women and infants.

• H1b: An automated pregnancy and birth registry will be transferrable from one OpenMRS site to another (USAID-AMPATH to FACES)

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Maternal Variables

Cross sectional Variables:• Date of Birth• *Antiretroviral regimens prior to pregnancy• *Start date of initial antiretroviral regimen• Date of last menstrual period• Pregnancy outcome• EDD (estimated date of delivery)

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Maternal Variables

Longitudinal variables• WHO stage each visit • WHO stage 3 and 4 conditions each visit • Antiretroviral regimen • Other medications (including OI prophylaxis) • Gestational age at all visits during pregnancy• * Reason for regimen stop/change• * CD4 counts • * Safety labs done (i.e. AST, ALT, Creat, CBC)• * VL when available

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Infant VariablesCross Sectional Variables:• Date of Birth• Type of delivery• Method of delivery• gender • physical exam findings at first visit (assessment of

congenital abnormalities)• Birth weight• Estimated gestational age at delivery (i.e., pre-term

or full-term)

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Infant VariablesLongitudinal variables during first 24 months:• Weight• Length• Head circumference• *DNA PCR results• *ELISA results• *Antiretrovirals• * Reason for regimen stop/change• *CD4 count (HIV infected only)• *VL (HIV infected only)• *Safety labs (i.e. AST, ALT, Creat, CBC)

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Way Forward

• Year 1: Automate Registry at AMPATH• Year 2: Automate registry at FACES• Year 3: Is it possible to do this at other

OPENMRS sites?– What barriers must be overcome in order to move

forward?

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