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Search / Trial NCT06979492

Prophylactic Transfusion In Pregnant in Women With Sickle Cell Disease

Launched by EMORY UNIVERSITY · May 13, 2025

Trial Information

Current as of August 21, 2025

Not yet recruiting

Keywords

Blood Transfusion Anemia

ClinConnect Summary

This clinical trial aims to investigate whether giving red blood cell transfusions to pregnant women with sickle cell disease (SCD) can help reduce complications related to their condition and pregnancy. The study will compare the effects of these transfusions to standard care, looking at how often women experience serious symptoms or complications that require urgent medical attention during their pregnancy and for two months after giving birth. Red blood cell transfusions are a common way to manage sickle cell disease, but there isn’t a clear agreement on how effective they are in preventing complications during pregnancy.

To participate in this study, women must be 18 years or older, currently pregnant between 6 to 20 weeks, and have a diagnosis of sickle cell disease. They should also be willing to understand the study's purpose and give consent to join. Participants will be randomly assigned to receive either the transfusions or standard care and will be involved in the study for about 8 to 10 months, which includes their pregnancy and a couple of months after delivery. This trial is not yet recruiting, so it’s important to keep an eye out for updates if you're interested.

Gender

FEMALE

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 Emory University

Emory University, a leading research institution located in Atlanta, Georgia, is dedicated to advancing medical knowledge and improving patient care through innovative clinical trials. With a strong emphasis on interdisciplinary collaboration, Emory harnesses the expertise of its renowned faculty and state-of-the-art facilities to conduct cutting-edge research across various fields, including oncology, neurology, and infectious diseases. The university's commitment to ethical research practices and patient safety ensures that all clinical trials are designed to generate valuable data that can lead to significant therapeutic advancements. By fostering partnerships with local hospitals and community organizations, Emory strives to translate research findings into real-world applications, ultimately enhancing health outcomes for diverse populations.

Locations

Atlanta, Georgia, United States

Patients applied

0 patients applied

Trial Officials

Ross Fasano, MD

Principal Investigator

Emory University

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported