Protocol adherence and transfusion data
| . | Intervention (n = 17) . | Control (n = 17) . |
|---|---|---|
| At least 1 SPEBT during pregnancy, n (%) | 12∗ (70.6) | - |
| Number of SPEBT during pregnancy, mean (SD); range | 2.6 (2.02); 0-5 | - |
| ≥3 SPEBT during pregnancy†, n (%) | 11‡ (64.7) | - |
| ≥3 SPEBT in participants not withdrawn from the trial for medical reasons, n (%) | 11/14 (78.6) | - |
| Number of patients with at least 1 clinically indicated transfusion during pregnancy, n (%) | 6§ (35.3) | 16 (94.1) |
| Number of clinically indicated transfusion episodes during pregnancy, mean (SD); range | 0.35 (0.49); 0-1 | 2.1|| (1.6); 0-5 |
| ≥2 clinically indicated transfusion episodes during pregnancy, n (%) | 0 (0) | 8 (47.1) |
| Number of RBC units transfused during pregnancy, n | 371 | 180 |
| Number of RBC units transfused during pregnancy, mean (SD); range | 21.8 (15.7); 0-45 | 10.6 (12.7); 0-39 |
| . | Intervention (n = 17) . | Control (n = 17) . |
|---|---|---|
| At least 1 SPEBT during pregnancy, n (%) | 12∗ (70.6) | - |
| Number of SPEBT during pregnancy, mean (SD); range | 2.6 (2.02); 0-5 | - |
| ≥3 SPEBT during pregnancy†, n (%) | 11‡ (64.7) | - |
| ≥3 SPEBT in participants not withdrawn from the trial for medical reasons, n (%) | 11/14 (78.6) | - |
| Number of patients with at least 1 clinically indicated transfusion during pregnancy, n (%) | 6§ (35.3) | 16 (94.1) |
| Number of clinically indicated transfusion episodes during pregnancy, mean (SD); range | 0.35 (0.49); 0-1 | 2.1|| (1.6); 0-5 |
| ≥2 clinically indicated transfusion episodes during pregnancy, n (%) | 0 (0) | 8 (47.1) |
| Number of RBC units transfused during pregnancy, n | 371 | 180 |
| Number of RBC units transfused during pregnancy, mean (SD); range | 21.8 (15.7); 0-45 | 10.6 (12.7); 0-39 |
Intervention arm consists of serial prophylactic exchange transfusion; control arm consists of standard care.
One participant from the intervention arm was excluded from the analysis because of a spontaneous abortion occurring at <16 weeks before the first procedure.
Five women allocated to the intervention arm did not have any SPEBT for the following reasons: complex pregnancy with fetal abnormalities (n = 1), withdrew from SPEBT program after randomization but continued in study (n = 3), venous access not achieved (n = 1).
Three or more SPEBT during pregnancy was identified as an indicator of “dose/acceptability” for the feasibility study.
One woman allocated to the intervention arm had only 1 SPEBT because of delayed hemolytic reaction after first procedure.
Three intervention arm participants who withdrew from SPEBT program received 1 clinically indicated transfusion later in pregnancy.
The indications for transfusion in control arm were recorded in 11 patients and included sickle cell crisis (54.5%), severe anemia (27.3%), previous severe pregnancy complications with intensive care admission and kidney failure (9.1%), and acute chest syndrome (9.1%).