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Research in pregnant and breastfeeding women is a complex area, with both the wellbeing of the mother and child paramount. Careful monitoring of any intervention to treat, or prevent, illness is required to ensure the benefits outweigh any harms.
Conventional pharmacovigilance tools are often not appropriate for monitoring interventions given to mothers and fail to take into account outcomes of the child. Newborn assessments should be conducted routinely and systematically to determine if there are any outcomes that could be related to in-utero exposure. Children who are potentially exposed to investigational interventions via breastmilk should also undergo regular examination to detect any possibly related harms.
Fit-for-purpose tools for use in these circumstances are required and have been developed by the Malaria in Pregnancy (MiP) Consortium. The MiP Consortium in an international research collaboration of 47 partner institutions in 32 countries. Established in 2009 with an initial grant from the Bill and Melinda Gates Foundation and continued support from the European Union and the European & Developing Countries Clinical Trials Partnership (EDCTP), its mission is to improve the control of malaria in pregnancy.
The MiP Consortium conducted a number of studies in pregnant women to gather evidence on the most effective method of treating and preventing malaria, in order to improve health outcomes in both the mother and her offspring. Consequently, they have developed a range of tools which can be used to monitor the safety of such interventions and to assess outcomes in both the mother and the child. Whilst these tools were developed for monitoring the use of antimalarials, their use can be extended to other drugs, interventions and illnesses.
See the MiPc resources page for lots of tools and resources which you can download and use.