An NIHR-funded feasibility trial led by Professor Eugene Oteng-Ntim at Guy’s and St Thomas’ is investigating whether pregnant women with sickle cell disease would be willing to take part in a study which randomises them to having regular exchange blood transfusions throughout their pregnancy to compare this with normal standard care.
Sickle cell disease is the name for a group of inherited health conditions that affect red blood cells and can cause a number of complications. It is particularly common in people with an African or Caribbean family background.
Pregnant women with sickle cell in particular have an increased risk of both sickle and pregnancy complications, including raised blood pressure. Their babies are also at higher risk of some complications.
One of the main drugs used to treat the condition is not safe for use in pregnant women, reducing options for treatment significantly. Top up or exchange blood transfusions, where total blood volume is exchanged for non-sickle affected blood, are currently used to treat emergency symptoms.
In the TAPS2 trial, pregnant women will be randomly assigned to receive either scheduled exchange blood transfusion every 6-10 weeks regardless of their symptoms versus standard care, where women will have exchange blood transfusions when clinically indicated. The care package for both groups will otherwise be the same. The trial will primarily assess how acceptable women find the opportunity to participate in the trial. The study will also monitor outcomes to see if there is any difference in health status for both mother and baby in the exchange blood transfusion arm when compared with the current standard treatment arm.
The TAPS2 feasibility study also includes a qualitative element which will include women’s experiences of participating in the trial, women’s reasons for declining participation in the trial and asking staff how they found recruiting women into the study.
Vicky Robinson, TAPS2 senior research midwife at Guy’s and St Thomas’, said: “Women with sickle cell disease have an increased risk of complications during pregnancy as well as compounding their likelihood of having a sickle cell crisis or associated conditions. We’re keen to find out if women are willing to participate in the TAPS2 trial in the first instance and then to see if serial exchange blood transfusions have any effect on mums’ and babies’ wellbeing when compared with current standard care. TAPS2 is seeking to recruit 50 women over the course of the study at Guy’s and St Thomas’ and four other sites within London – King’s College Hospital, The Whittington, St George’s and the Royal London, as well as St Mary’s in Manchester. We know that some sickle cell patients have benefitted from this kind of intervention. For instance, studies run at Guy’s and St Thomas’ have shown that additional transfusions before surgery reduce the likelihood of complications in sickle cell patients.
“We’re keen for women with sickle cell disease who are in the early stages of pregnancy (up to 18 weeks) to take part in the study. We are also talking to women who don’t want to take part, in order to understand the potential barriers to recruitment for this treatment.”
Women interested in taking part can contact us on Taps2@gstt.nhs.uk or by calling 020 7188 3634.
The TAPs2 study is supported by the NIHR Research for Patient Benefit Programme.