Actively Recruiting

Phase 4
Age: 18Years +
FEMALE
Healthy Volunteers
NCT06979492

Prophylactic Transfusion In Pregnant in Women With Sickle Cell Disease

Led by Emory University · Updated on 2026-02-18

50

Participants Needed

1

Research Sites

108 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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).

CONDITIONS

Official Title

Prophylactic Transfusion In Pregnant in Women With Sickle Cell Disease

Who Can Participate

Age: 18Years +
FEMALE
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Female
  • Diagnosis of sickle cell disease of any genotype (HbSS, HbSC, HbSb2 thalassemia)
  • Age 18 years or older
  • Currently pregnant between 6 and 20 weeks of gestation
  • Able to understand the study and give informed consent
  • For those with private insurance, pre-approval for blood transfusions
Not Eligible

You will not qualify if you...

  • Currently receiving chronic transfusion therapy before pregnancy
  • History of delayed hemolytic transfusion reaction (DHTR) with hyperhemolysis
  • Red cell antibody history preventing adequate transfusion support
  • Unable or unwilling to receive blood transfusions for social, religious, or clinical reasons
  • Known current triplet pregnancy
  • Major medical or psychiatric illness preventing participation as judged by clinician

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Grady Health System

Atlanta, Georgia, United States, 30303

Actively Recruiting

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Research Team

R

Ross Fasano, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

PREVENTION

Number of Arms

2

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