Protecting Pregnant women from malaria: exploring safety data Bali | 11 – 12 October 2017

JR Poespoprodjo, MD PhD; Rukhsana Ahmed, MD, Mpaed, PhD

Defeating Malaria Together

Dihydroartemisinine-piperaquine experience in Timika, Papua

• Indonesia is the first country to introduce DP for treatment malaria

• It became policy in March 2006-changed from CQ-SP

• Same time for treatment of 2nd & 3rd trimester pregnancy & infants

• Data available electronically in the hospital

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Safety of artemesinins in first trimester-what is known

• Malaria in 1st trimester is known to be associated with pregnancy loss (miscarriage or stillbirth)

• ACTs more effective than quinine, well tolerated and already widely used in 1st trimester

• Quinine is not well tolerated and poor compliance to 7 day treatment -> untreated malaria

• Safety data is limited but doesn’t indicate any safety signal with artemisinins in humans

• 90% of ACT safety data comes from artemether-lumefantarine

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First Trimester DHP exposure study

• Rationale: • Has a computerized recording

system in the hospitals • Larger database at our disposal

for data abstraction • Infrastructure and trained staff

experienced in obtaining data in place

• An extension of existing collaboration between Timika research facility and LSTM

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First trimester DHP exposure study Timika Indonesia

• Objectives • Compare the risk of miscarriage and stillbirths between women treated

with DHP and quinine in 1st trimester • Compare the risk of congenital anomalies in between women treated

with DHP and quinine in 1st trimester • Secondary: assess maternal, fetal and infant morbidity and mortality

outcomes during 8 weeks post-natal period

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Study design

• Observational record linkage retrospective & prospective component

• Sample size: • Retrospective: 1500 exposures (225 DHP & 1245 quinine) • Prospective: 298 women ( 50 DHP, 248 quinine (

inadvertent)

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Retrospective cohort-record linkage

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Exposure

quinine

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Data source

emergency

delivery

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Miscarriage Stillbirth

Congenital anomalies

outcome

Prospective cohort

Eligibility criteria

Check gestational age by U/S: < 24 weeks Confirm malaria/fever history (recall), treatment –past 6 months Check medical records for treatment: DP/quinine

Follow-up antenatal visit

Fetal viability h/o fever, malaria Drug treatment

Delivery & post natal

Term/preterm Baby: surface examination for congenital anomalies Birth weight

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Outcomes of study

• Expected to add to existing safety data • Pregnant women: miscarriage and stillbirths • Newborns: surface congenital anomalies, preterm birth

(babies) • Post-natal: maternal and infant morbidity and mortality

upto 6-8 weeks

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Acknowledgement

• MMV for funding the study

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