African mother and baby

Malaria in Mothers and Babies Pregnancy Exposure Registry - MiMBa

Malaria in Mothers and Babies Pregnancy Exposure Registry - MiMBa

There is generally limited or no drug safety data related to pregnant women, particularly for drugs targeting infectious diseases in resource-limited settings. Developing surveillance systems to assess the safety of these drugs in pregnancy is critical.

Currently there are limited treatment options for pregnant women with malaria during the first trimester due to the fear of harming the unborn baby, and the limited available data on the safety of most antimalarials used during pregnancy.

In many cases, women in the early stages of pregnancy are inadvertently treated with the same antimalarials given to the adult population either because they were unaware or did not wish to disclose they were pregnant. Until recently, quinine was the recommended treatment for malaria in the first trimester, yet it has significant side effects, a lengthy and complex treatment course and is no longer widely available. A recent review of all studies assessing the safety of artemisinin-containing antimalarials in the first trimester of pregnancy found that there was no increased risk of adverse pregnancy outcomes than non-artemisinin-based treatments, including quinine-based regimens. Importantly, artemether-lumefantrine, the ACT with the most safety data, was associated with 42% fewer adverse pregnancy outcomes (pregnancy loss or major congenital malformations) than oral quinine in the first trimester. Based on this evidence, in November 2022 the World Health Organization updated its guidelines for the treatment of malaria in the first trimester from quinine to artemether-lumefantrine. It recommends other ACTs (including artesunate-amodiaquine, artesunate-mefloquine and dihydroartemisinin-piperaquine) where artemether-lumefantrine is not available, but not artesunate-sulfadoxine–pyrimethamine due to contraindication of the partner drug.  However, more data are needed on a wider range of ACTs as most of the data available to date relates to artemether-lumefantrine.

Developing a registry

The overall aim of the registry is to generate robust data on the safety of antimalarials in pregnancy to inform regulators and policy makers and support informed decision making by healthcare providers and pregnant women needing treatment for malaria. Several steps have been identified to accomplish this aim 

1) Development of a suitable surveillance methodology adapted to malaria endemic country settings;

2) Selection of suitable sites to enable collecting exposure data on a wide range of antimalarial of interest to the registry;

3) Implement field activities and data collection to generate robust evidence on first trimester exposed pregnancies with an infant follow up to 12 months post-delivery;

4) Support marketing authorisation holders to submit new data to relevant regulators and

5) Share the new evidence to the World Health Organization to inform ongoing review of treatment guidelines.

Current activities

  • Data collection is ongoing in three sites in western Kenya (Homa Bay sub-county, Mfangano and Rusinga islands) and two sites in Burkina Faso (Nanoro and Soaw). These sites include 40 health facilities, and approximately 70,000 women of childbearing age are invited to participate in the study.
  • As of December 2022, over 60,000 women (15-49 years) were enrolled in the study, and over 12,000 pregnancies were detected in this cohort.

The team is actively looking for additional eligible sites, and data collection will be ongoing until at least 2024. If you are interested in participating in the registry, please contact Clio Whitby at LSTM 

Read the MiMBa Pregnancy Registry protocol (identifier: NCT04825782)

KEMRI scientists examine safety of anti-malarial drugs in first trimester of pregnancy

Kenya’s Citizen TV and its Newsnight programme reporting on the work currently being undertaken in Kenya by KEMRI scientists as part of the MiMBa project to examine safety of antimalarial drugs in first trimester of pregnancy. The segment includes an interview with Dr Hellen Barsosio, the co-Programme Investigator for Kenya.

Collaborators

Contact us

For more information about the project contact Clio Whitby, Programme Coordinator for the MiMBa Project at LSTM. clio.whitby@lstmed.ac.uk