Background

Rebekah Burrow is leading this research.

When I started research on this subject, it wasn't clear to me what researchers already knew and what questions still needed to be answered. Four colleagues, Holly Lovell, Laura Hermann, Julian Treadwell and Nia Roberts helped me work this out. We decided to carry out a "rapid scoping review". This is a type of research that systematically searches for the research that has already been done, using rigorous methods, and some shortcuts when they were unlikely to bias our results, to identify the main findings quickly. We have recorded the methods we are using, here. Riyadh Rahman, Luke Robles, Kirandeep Sunner, Haseeb Imtiaz and Katie Arundell joined the team to carry out the research.

What is the problem?

Pregnant and breastfeeding women and people are included in clinical trials mainly when the trial is testing something related to the pregnancy, or birth, or care after birth, that might help the mother, birthing parent or baby. Women have historically been excluded from clinical trials and continue to be under-represented. Pregnant and breastfeeding women and people are still 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.

Many pregnant and breastfeeding 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 during pregnancy and breastfeeding. They also often don’t know if the care they would normally give works as well. Sometimes, this means doctors and midwifes do not provide standard care, even when it is safe and effective. Without this care, babies are more likely to be born prematurely, or die. Women and pregnant people are more likely to die.

There are lots of reasons why pregnant and breastfeeding people are not included all clinical trials. In the past, some women and babies have been harmed by treatments (that were not tested in clinical trials).

Some clinical trials have proved it is possible to include pregnant people, even in tricky situations. Many pregnant and breastfeeding 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 could benefit them or their baby. 

What research are we doing?

We are bringing together all the relevant current knowledge about:

• whether pregnant and breastfeeding people included in clinical trials that are not only about the pregnancy and breastfeeding
• whether pregnant or breastfeeding people would choose to take part in trials like these
• what stops them from taking part, or helps them to take part

Where are we up to with this research?

We are writing up our findings now. The review should be published by the end of 2026.

Patient and Public Involvement (PPI)

We talked to women with experience of pregnancy. We asked about their experiences while pregnant, including their access to treatments, information about treatments, and participation in research. We also asked about their opinions of, and interest in, research to increase inclusion in research during pregnancy. Three PPI contributors reviewed our results and helped us decide how to show them, and what they mean. This webpage was developed with support from PPI contributors.