What is the study about?

Pre-eclampsia is a condition which can develop in some pregnancies, usually during the second half of pregnancy (from 20 weeks). It causes high blood pressure and strain on the woman/birthing person’s body systems. It can cause the baby to be too small and the placenta to not work properly. Because there is no treatment for pre-eclampsia, once it develops the baby often has to be delivered early.

Pre-eclampsia is a leading cause of pre-term birth (birth before 37 weeks gestation), which can lead to serious health challenges for the baby in the days and weeks after birth, but also life-long health challenges. Pre-eclampsia can be life threatening for the woman/pregnant person and child; 1 in every 100,000 UK pregnant people and 1 in every 1,000 UK babies die due to pre-eclampsia.

There is no treatment for pre-eclampsia, but a small daily dose of the medicine aspirin is regularly prescribed to help prevent pre-eclampsia. Because of this, it is very important that screening tests can identify those women/birthing people with a high risk of developing pre-eclampsia.

Who can take part in the study?

The STARshiP study is taking place in 16 maternity trusts across the north of England and the Midlands.

What is being tested in the study?

The STARshiP study (Screen and Treat with Aspirin to Reduce Pre-eclampsia) is looking at whether using a new pre-eclampsia screening test from the Fetal Medicine Foundation (FMF) reduces the risk of preterm birth compared to the current NICE screening strategy in place in the UK (National Institute for Health and Care Excellence).

STARshiP is comparing two different screening strategies:

· NICE: The pre-eclampsia risk assessment test currently in use in the UK. Uses background information about pregnant people and their family to understand pre-eclampsia risk.

· FMF: A relatively new test developed by researchers in London. Uses extra measurements of how the placenta is working to personalise the pre-eclampsia risk assessment to the current pregnancy.

What is this being compared to?

The FMF screening test is being compared to the current UK NICE screening strategy.

What are we trying to find out?

We are trying to find out if the new FMF screening test reduces preterm birth.

How many people will be involved?

The trial will be looking at over 200,000 women and their babies

Funder

National Institute for Health and Care Research - Health Technology Assessment (NIHR - HTA)