Supporting clinical trialists to include pregnant women and people in non-obstetric clinical trials

What is the problem?

Pregnant women and people are included in clinical trials when the trial is testing something related to the pregnancy, or birth, that might help the mum or baby. Pregnant women and people are not allowed to take part in most clinical trials. For example, they are often excluded from trials testing a drug to manage depression, a vaccine to prevent COVID, or a test for urinary tract infections.

Why does it matter?

Many pregnant women and people have common medical conditions. Without evidence from clinical trials, doctors and midwives often don’t know if the care they would normally give is safe for the mum and baby. They often don’t know if the care they would normally give works as well when someone is pregnant. Sometimes, this means doctors and midwifes do not give the normal care that would be safe and effective. Without this care, babies are more likely to be born prematurely, or die. Mothers are more likely to die. There are lots of reasons why pregnant women and people are not included in all clinical trials. Sometimes it isn't appropriate. But some clinical trials have proved it is possible to safely include pregnant women and people, even in some tricky situations. Many pregnant women and people would like to be given the choice of whether or not to take part in clinical trials. They say they want to help other people, or they hope it will provide better care, or some other benefit for them or their baby.

What questions will this research answer?

• what might help researchers to include women and people who are pregnant?
• how can we develop a tool together that might help include pregnant women and people?
• how well does the tool work in real clinical trials?

How will I do this research?

• a map of organisations to show which can undertake research with pregnant women and people
• an online survey and focus groups with different researchers to find out more about what might help them run more inclusive trials
• a co-production workshop so researchers can work together to design the tool
• testing the tool in two real clinical trials to find out whether it helps researchers to include pregnant women and people

How do I work with women and people with experience of pregnancy and caring for pregnant people?

I am working with charities that support patients and communities. I have set up a Patient and Public Involvement (PPI) Advisory Group and an Expert Advisory Group who support my work.

How will it have impact?

If it works well, the tool will be used by clinical trialists in the UK. This will increase the number of trials including pregnant people, and the number of pregnant people taking part in trials. Later, this will reduce the number of babies born prematurely, or dying, and reduce the number of mothers who die.