Prophylactic Transfusion In Pregnant in Women With Sickle Cell Disease
The goal of this study is to determine if there is a positive effect of prophylactic red blood cell (RBC) transfusion of leukoreduced, ABO, Rh (D/Cc/Ee) and Kell matched blood compared to standard of care on the number of episodes of acute sickle cell disease (SCD) manifestations or pregnancy-related complications requ
| Condition(s) | Sickle Cell Disease, Pregnancy Related |
|---|---|
| Status | Recruiting |
| Phase | Phase 4 |
| Study type | Interventional |
| Summary | The goal of this study is to determine if there is a positive effect of prophylactic red blood cell (RBC) transfusion of leukoreduced, ABO, Rh (D/Cc/Ee) and Kell matched blood compared to standard of care on the number of episodes of acute sickle cell disease (SCD) manifestations or pregnancy-related complications requiring acute health care encounters (acute care/ER/Hospital visits) or resulting in death over the entirety of pregnancy until 2 months post-partum in women with SCD. RBC transfusion is the only disease-modifying therapy for pregnant women with SCD, and it is considered a standard treatment option however, there exists no consensus on the role of transfusion therapy in preventing SCD-related pregnancy complications. Participants will be randomly assigned to repeated red blood |
| Who can participate | Inclusion Criteria: * Female * Diagnosis of SCD of any genotype (i.e., HbSS, HbSC, HbSβ thalassemia) * 18 Years and older * Currently pregnant at 6 weeks through 20 weeks of gestation. * Ability to understand the purposes and risks of the study and willingly give informed consent. * For participants with private health insurance, insurance pre-approval for blood transfusions Exclusion Criteria: * Currently on chronic transfusion therapy before pregnancy * Prior history of DHTR with hyperhemolysis * Red cell antibody history, which would prevent the provision of adequate red cell units to support chronic transfusions. * Unable or unwilling to receive blood transfusion for social, religious, or clinical reasons * Known current triplet pregnancy * Current diagnosis of major medical or psychia |
| Ages | 18 Years |
| Sex | Female |
| Accepts healthy volunteers | Yes |
| Lead sponsor | Emory University |
| Locations | Atlanta, Georgia, United States |
| Start date | 2026-04 |
| NCT ID | NCT06979492 |
| Official listing | https://clinicaltrials.gov/study/NCT06979492 |