Background

Rebekah Burrow is leading this research.

When I started research on this subject, it wasn't clear to me what researchers already knew about this subject, and what I needed to find out next. Four colleagues, Holly Lovell, Laura Hermann, Julian Treadwell and Nia Roberts helped me to figure this out. We decided to carry out a "rapid scoping review". This is a type of research with a systematic search for the research that has already been done, using rigorous methods, and shortcuts when they were unlikely to bias our results, to get the headline results. We have recorded the methods we are using, here. Riyadh Rahman, Luke Robles, Kirandeep Sunner, Haseeb Imtiaz and Katie Arundell joined the team to undertake the research.

What is the problem?

Pregnant and breastfeeding women and people are included in clinical trials 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 are still 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. 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 normal care that 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. 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 will provide better care, or some other benefit for them or their baby. 

What research are we doing?

We are bringing together all the relevant current knowledge about:

• Are pregnant and breastfeeding people included in clinical trials that aren't only about the pregnancy and breastfeeding?
• Would any pregnant or breastfeeding people 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 in the final stages of finding all the research that has already been done. We have extracted information from 56 scientific papers, and are starting to analyse the data. The review should be completed by the end of 2025.