Maternal Health Pipeline

The Accelerating Innovation for Mothers (AIM) project – spearheaded by the Concept Foundation and delivered in partnership with Impact Global Health (formerly Policy Cures Research) and Burnet Institute – was created with the aim of fostering greater investment in and development of critical maternal health products for seven significant pregnancy-related conditions, where biomedical product gaps exist: 

• Preterm labour/birth
• Preeclampsia/eclampsia
• Intrauterine growth restriction 
• Postpartum haemorrhage
• Intrapartum foetal distress
• Maternal enteric microbiome/environmental enteric dysfunction
• Maternal iron deficiency anaemia

As part of this work, we created a comprehensive database profiling medicines, diagnostics, and devices – both approved and in the development pipeline – for these seven conditions.

The Maternal Health Pipeline includes:

• medicines for preterm labour/birth, preeclampsia/eclampsia, intrauterine growth restriction, postpartum haemorrhage, intrapartum foetal distress, maternal enteric microbiome/environmental enteric dysfunction, and maternal iron deficiency anaemia.
• diagnostic tests for preeclampsia/eclampsia, preterm labour and intrauterine growth restriction, and
• devices for postpartum haemorrhage.

To be included in the pipeline, the medicines, diagnostic tests and devices had to either be in active discovery/pre-clinical or clinical development now, or have been in development at one point between 2000 and 2023, or be approved and registered for clinical use and/or be used currently in clinical treatment (off-label).

To develop this database we:

1. Identified and validated candidates through multiple sources that are or were in the pipeline for each of the identified pregnancy-related conditions since 2000;
2. Collected information on the candidate’s preclinical or clinical development, and associated data;
3. Researched additional context around the product (e.g. development history, stakeholders);
4. Validated and sense checked candidate profiles through independent, external reviews by clinical research specialists in the field.

Please see pages 6-18 of this report for the full methodology.

Following database completion, a series of internal and external, independent reviews are undertaken to clean and validate the data. Internally, each candidate is reviewed for content, consistency, and logic by a minimum of two and often three or four individuals. Data cross checking and cleaning is conducted in a rigorous, sequential manner. Some steps serve to clean and standardise the data, while others were intended to identify content or subject matter error.

External review is also undertaken. We seek, as needed, independent, specialist input from external reviewers actively working on new drugs development for one or more of the pregnancy-related conditions under investigation. At different times, the entire database has been reviewed to validate candidates or identify known missing candidates; review the essential, standard labels for the candidates; review the fields related to clinical use case; and for each, recommend corrections, improvements, or additional details. Advisory input from the AIM team and the project’s expert advisory committee is also sourced throughout data compilation, as needed.

Due to the proprietary nature of and lack of publicly available information on many, particularly preclinical, candidate investigations, we anticipate the data may have gaps with respect to the full body of research. We also acknowledge that the data sources used that rely on self-reporting by investigators (e.g. ICTRP) have their own inherent limitations, including potential for reporting biases arising from changes in adherence and utilisation over time.