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Characteristics of tools that predict preterm birth: a new target product profile

We are seeking your feedback

We've developed a document that describes the minimum and ideal characteristics of health products that predict preterm birth in women who have symptoms of preterm labour. This type of document is called a target product profile or TPP.

This target product profile helps people design and develop effective and affordable biomarker tests for prediction of preterm birth in women with symptoms of preterm labour. It aims to help improve maternal health outcomes globally.

We are seeking feedback from stakeholders on this draft target product profile.

View the draft target product profile on preterm labour and preterm birth (DOCX 124KB).

You can provide feedback by contacting kate.mills@burnet.edu.au or complete the online survey on our draft target product profile. The survey is available in English, French and Spanish.

 

Preterm birth explained

Preterm birth (being born alive at fewer than 37 weeks’ gestational age) affects an estimated 13.4 million babies annually, with the greatest burden in limited-resource settings. Preterm birth and its associated complications are the leading cause of death in newborns and children under five. Babies who survive preterm birth are at increased risk of a wide range of morbidities—such as respiratory distress syndrome, cerebral palsy and infections—as well as poorer health and educational outcomes in the longer term.

The World Health Organization recommends several interventions to improve outcomes of babies born preterm. Administration of tocolytics can delay labour, allowing for the transfer to a higher-level facility and/or administration of other drugs (such as antenatal corticosteroids or magnesium sulfate) to improve preterm newborn outcomes.

Symptoms of spontaneous preterm labour, such as preterm contractions and cervical changes, can signal the possibility that preterm birth may occur imminently. However, less than 10% of women presenting with these symptoms give birth within seven days. A test which can accurately identify which women will (or will not) experience an imminent preterm birth would allow for targeted, appropriate and timely use of antenatal interventions.

Though there are a few tools in clinical use for predicting preterm birth in women presenting with preterm labour symptoms, biomarker tests have been identified as the most promising. Despite some advancements, existing biomarkers tests for preterm birth prediction lack accuracy and affordability and are frequently unavailable due to limited manufacturing. In low- and middle-income countries, where health systems constraints and inequities in accessing care are common, these challenges are more pronounced.

 

Partners

Gates Foundation

 

Collaborators

Concept Foundation

 

More information

For more information, contact kate.mills@burnet.edu.au