Transfusion Antenatally in Pregnant Women with SCD (TAPS2)

Pregnant women with Sickle Cell Disease (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, 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, but a trial is required to demonstrate this.

The TAPS2 study is a feasibility study which aims to recruit 50 women at six clinical trial centres (five in London and one in Manchester).   TAPS2 will look firstly at whether women choose to participate and then how acceptable women find taking part in the trial; additionally we will record the health statuses of women and babies who take part.  The results of this trial will be used to decide whether a larger study is indicated.

Women who choose to take part will be randomised to one of two groups; either serial prophylactic exchange blood transfusions (EBT) or to normal clinical care, whereby EBTs will be arranged when clinically indicated.  Some of the women will also be asked their about decision to participate in TAPS2 and what their experiences were from both groups.  TAPS2 will also be asking women who decline to participate about their thoughts and opinions when deciding to decline the trial.

To be eligible to take part in the trial, women need to meet the inclusion criteria and none of the exclusion criteria:

Inclusion criteria:

• Pregnant women with SCD (all types).  This must be confirmed by a laboratory report
• Singleton pregnancies
• 18 years or older
• Gestation less than 18 weeks
• Willing and able to give informed consent

Exclusion criteria:

•  Women on long term transfusion programme prior to pregnancy for the improvement of Sickle Cell Disease
• Prior Hyperhaemolysis
• Red cell phenotype or antibodies present prevent likely provision of adequate red cell units to support elective EBT programme
• Women unable to receive blood transfusion for social, clinical or religious reasons
• Pregnant women with sickle cell disease with current diagnosis of major medical or psychiatric complications which the clinicians working on the study believe is contraindicated for the TAPS2 trial.

You can find more information about the clinical trial, including how to contact the study coordinators, on clinicaltrials.gov under the study ID number NCT03975894 .

Clinical Trial Locations:

Guy’s and St Thomas Hospital Foundation Trust- London, United Kingdom

Contact: Professor Eugene Oteng-Ntim

Kings College Hospital NHS Trust – London, United Kingdom

Contact: Dr Jemma Johns/Dr Moji Awogbade

Royal London– London, United Kingdom

Contact: Dr. Paul Telfer/ Dr. Filipa Barroso

St George’s University Hospital NHS Foundation Trust– London, United Kingdom

Contact: Dr Ingrid Watt-Coote

St Mary’s Hospital- Manchester, United Kingdom

Contact: Dr Joseph Sharif

Whittington Hospital- London, United Kingdom

Contact: Dr Emma Drasar

For more information: e: Taps2@gstt.nhs.uk t: 020 7188 3634