Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 3:15 PM
Ignite Modification Date:
2025-12-24 @ 3:15 PM
NCT ID:
NCT06979492
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.
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT06979492
Study Brief:
Protocol Section:
NCT06979492