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Prophylactic Transfusion In Pregnant in Women With Sickle Cell Disease
Who can join
Ages 18 and older · Women · Healthy volunteers welcome
Full eligibility criteria
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 psychiatric comorbidity, which in the randomizing clinician's opinion renders them unable to enter a clinical trial.
About the study
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 cell transfusions or the standard of care. Participants will be on study for about 8-10 months (Pregnancy through 2 months post-partum).
What is being tested
- Prophylactic Transfusion Intervention group: Transfusion (biological)
- Control group (other)
Sponsor: Emory University · Participants: 50 · Started: 2026-04
Contact the study team
- Ross Fasano, MD · Phone: 404-712-5227
Official record on ClinicalTrials.gov — NCT06979492
Locations in the U.S.
| Georgia | Grady Health System, Atlanta |
Conditions
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.