NCT06979492WithdrawnPhase 4
Prophylactic Transfusion In Pregnant in Women With Sickle Cell Disease
Source: ClinicalTrials.gov · Last updated 19 Oct 2026
Reason given: The study was withdrawn due to no enrollment
Brief summary (registry, in English)
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).
- Status (registry)
- Withdrawn
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 0 (actual)
- First submitted
- 13 May 2025
- Start date
- Sept 2026
- Primary completion date
- May 2028
- Lead sponsor
- Emory University
- Diseases
- Sickle cell disease
- NCT number
- NCT06979492
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
Other illness
- Current diagnosis of major medical or psychiatric comorbidity, which in the randomizing clinician's opinion renders them unable to enter a clinical trial.
Other
- Unable or unwilling to receive blood transfusion for social, religious, or clinical reasons
- Known current triplet pregnancy
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: Female · Accepts healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Grady Health System | Atlanta | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.