A Feasibility Trial of Serial Prophylactic Exchange Blood Transfusion in Pregnant Women With Sickle Cell Disease Aiming to Improve Maternal and Infant Outcomes

Study point of contact

Eugene Oteng-Ntim
+00 44 (0)2071886874
[email protected]

Locations

6 United Kingdom sites

Age

> 18 Years

Phase

Phase 2

Study type

Interventional

Gender

Female

Interventions

Biological

Compensation

Unknown

About the study

Sickle Cell Disease (SCD) is a serious inherited blood disorder affecting red blood cells.
When oxygen levels drop the red cells become abnormally shaped and unable to move through the
blood vessels easily. Blood and oxygen do not reach body organs, resulting in episodes of
severe pain and other complications. Pregnant women with SCD have an increased risk of both
sickle and pregnancy complications, including raised blood pressure. Their babies may grow
more slowly in the womb, are more likely to be born early and need special care, and have a
higher risk of dying. The only treatments currently available for women with SCD are
Hydroxycarbamide (which cannot be used during pregnancy) and blood transfusion. Currently,
blood transfusion is only used during pregnancy to treat emergency complications. It has been
suggested that giving blood transfusions throughout pregnancy could improve outcomes for both
mother and babies. In Serial Prophylactic Exchange Blood Transfusion (SPEBT), sickle blood is
mechanically removed and simultaneously replaced with donor red cells. A trial is needed to
assess SPEBT given every 6-10 weeks, starting before 18 weeks of pregnancy, compared to
standard care. This trial will evaluate outcomes for women (e.g. hospital admission,
frequency of crisis) and their infants (e.g. early delivery, birthweight). However, the
feasibility of such a study needs to be assessed before embarking on a large multicentre
trial. This study is therefore a feasibility study in which we will randomly allocate
participants to have either SPEBT or standard care. The study will be carried out in multiple
maternity units in England and last two years. The willingness of eligible women to join the
study will be assessed, along with how many participants remain part of the study until the
end and if participants find the intervention acceptable.

participation requirements

– Pregnant women with sickle cell disease (all genotypes)

– Gestation 18+0 weeks or below

– Willing and able to give informed consent

– Singleton pregnancy

participation restrictions

– On long term transfusion programme prior to pregnancy for amelioration of SCD

– Prior Hyperhaemolysis

– Red cell phenotype or antibodies present prevent likely provision of adequate red cell
units to support elective EBT programme

– Unable to receive blood transfusion for social, religious or clinical reasons

– Current diagnosis of major medical or psychiatric comorbidity which in the randomising
clinicians opinion renders them unable to enter trial

Locations

  • London, United Kingdom, Barts Health NHS Trust [Not yet recruiting]
  • London, United Kingdom, Guy's and St Thomas' NHS Foundation Trust [Recruiting]
  • London, United Kingdom, King's College Hospital [Not yet recruiting]
  • London, United Kingdom, St George's University Hospitals NHS Foundation Trust [Not yet recruiting]
  • London, United Kingdom, Whittington Health NHS Trust [Not yet recruiting]
  • Manchester, United Kingdom, Manchester University NHS Foundation Trust [Not yet recruiting]
Last updated 2019-08-01 Enroll Now