"We are taking several steps to ensure the data we collect for the pregnancy registry are robust"

Dr Stephanie Dellicour

MMV has collaborated with the Liverpool School of Tropical Medicine to establish a registry to monitor the use of different antimalarials during pregnancy with an emphasis on the first trimester. The registry was launched in Kenya in February 2021, with the selection of a second country before the end of the year. The data gathered will inform policymakers regarding decisions that will ultimately benefit pregnant women at risk of malaria.

Dr Stephanie Dellicour discusses malaria in pregnant women and the malaria pregnancy registry.

1. What are the main gaps in the treatment and prevention of malaria in pregnant women?

A clear gap in treating this population is the limited number of interventions available. Pregnant women are typically excluded from clinical studies and it can take several years for enough real-world data to accumulate to support the use of an antimalarial during pregnancy. The most critical gap is providing safe and effective interventions during the first trimester, as this is a key period for foetal development.

Today, preventative antimalarials used during pregnancy are only recommended from the second trimester, leaving pregnant women unprotected against malaria when their unborn babies are most vulnerable. In addition, women usually attend their first antenatal clinic after the first trimester in malaria-endemic countries, meaning protective insecticide-treated nets are not provided earlier in pregnancy. Malaria in the first trimester is now recognized as an important risk factor for adverse pregnancy outcomes (including miscarriage, foetal growth restriction, low birth weight, and maternal anaemia). There is an urgent need to obtain the necessary data to enable a full risk-benefit assessment of the most suitable antimalarials for this high-risk group.

2. What is the benefit of setting up a pregnancy registry? Why does the use of antimalarials need to be monitored?

In most high-income countries, there are robust systems that allow monitoring of drug safety using electronic health records (e.g. prescriptions and outcomes for pregnant women); however, these systems are not available in most malaria-endemic countries. The pregnancy registry addresses this gap, giving us a proactive system, which can be used to collect safety data on the use of antimalarial drugs during pregnancy. These exposures need to be monitored so we can evaluate the risks and benefits of different antimalarials, ultimately helping pregnant women get access to new and more effective treatments faster.

3. What is being done to collect quality data to help address these gaps? What are the main challenges?

We are taking several steps to ensure the data we collect for the pregnancy registry are robust, including introducing obstetric ultrasound to help determine the exact gestational period as well as implementing training to improve the quality of congenital anomaly assessments. The main challenge is capturing accurate exposure information, as malaria can be a commonplace, forgettable event in areas of high transmission where antimalarials are widely available over the counter. This requires linking multiple data sources for confirmation of exposure.

4. How will the evidence generated be used?

The goal is to generate robust data that can be reviewed by regulators and policymakers, and then be used by healthcare providers and expectant mothers to make informed decisions on treatment.

5. How will the registry contribute to the control and ultimate elimination of malaria?

To eliminate malaria, it is crucial to reduce overall transmission, and pregnant women represent a small but important reservoir of infection. The safety data generated by the registry will help to expand the use of the tools at our disposal for the elimination of malaria.

6. What has it been like to work with MMV on this project? What do each of the partners bring?

It has been a true partnership and there is real synergy between all collaborators. MMV brings extensive industry knowledge, the team at Liverpool School of Tropical Medicine brings technical and field experience, and the WorldWide Antimalarial Resistance Network provides expertise for data management, curation, and analysis.