Maternal pregnancy and birth outcomes
| . | Intervention (n = 17) . | Control (n = 17) . | Comparison . | |
|---|---|---|---|---|
| RR (95% CI) . | Difference (95% CI) . | |||
| Antenatal admission for any reason, n (%) | 7 (41.2%) | 10 (58.8%) | 0.70 (0.35-1.40) | |
| Inpatient nights for any reason∗, mean (SD) | 4.71 (4.50) | 7.30 (8.93) | −2.59 (−9.64 to 4.47) | |
| Antenatal admission for SCD†, n (%) | 6 (35.3%) | 10 (58.8%) | 0.60 (0.28-1.28) | |
| Inpatient nights for SCD∗, mean (SD) | 3.33 (2.50) | 7.10 (9.05) | −3.77 (−10.35 to 2.81) | |
| Sickle cell crisis during pregnancy∗, n (%) | 8 (47.1%) | 13 (76.5%) | 0.62 (0.35-1.09) | |
| Severe crisis during pregnancy∗,‡, n (%) | 6 (35.3%) | 8 (47.1%) | 0.75 (0.33-1.70) | |
| Acute chest syndrome∗, n (%) | 0 (0.0%) | 1 (5.9%) | - | |
| Preeclampsia∗, n (%) | 0 (0.0%) | 2 (11.8%) | - | |
| Venous/pulmonary embolism in pregnancy∗, n (%) | 1 (5.6%) | 0 (0.0%) | - | |
| Onset of labor | ||||
| Spontaneous, n (%) | 0 (0.0%) | 2 (11.8%) | - | |
| Induced, n (%) | 8 (47.1%) | 10 (58.8%) | - | |
| Cesarean delivery, n (%) | 9 (52.9%) | 5 (29.4%) | - | |
| Emergency cesarean∗, n (%) | 3 (17.6%) | 1 (5.9%) | 3.00 (0.35-26.04) | |
| Elective cesarean, n (%) | 10 (58.8%) | 9 (52.9%) | 1.11 (0.61-2.02) | |
| Postpartum transfusion, n (%) | 2 (11.8%) | 6 (37.5%) | 0.31 (0.07-1.33) | |
| Proposed composite end point for TAPS3§, n (%) | 10 (58.8%) | 15 (88.2%) | 0.67 (0.43-1.03) | |
| . | Intervention (n = 17) . | Control (n = 17) . | Comparison . | |
|---|---|---|---|---|
| RR (95% CI) . | Difference (95% CI) . | |||
| Antenatal admission for any reason, n (%) | 7 (41.2%) | 10 (58.8%) | 0.70 (0.35-1.40) | |
| Inpatient nights for any reason∗, mean (SD) | 4.71 (4.50) | 7.30 (8.93) | −2.59 (−9.64 to 4.47) | |
| Antenatal admission for SCD†, n (%) | 6 (35.3%) | 10 (58.8%) | 0.60 (0.28-1.28) | |
| Inpatient nights for SCD∗, mean (SD) | 3.33 (2.50) | 7.10 (9.05) | −3.77 (−10.35 to 2.81) | |
| Sickle cell crisis during pregnancy∗, n (%) | 8 (47.1%) | 13 (76.5%) | 0.62 (0.35-1.09) | |
| Severe crisis during pregnancy∗,‡, n (%) | 6 (35.3%) | 8 (47.1%) | 0.75 (0.33-1.70) | |
| Acute chest syndrome∗, n (%) | 0 (0.0%) | 1 (5.9%) | - | |
| Preeclampsia∗, n (%) | 0 (0.0%) | 2 (11.8%) | - | |
| Venous/pulmonary embolism in pregnancy∗, n (%) | 1 (5.6%) | 0 (0.0%) | - | |
| Onset of labor | ||||
| Spontaneous, n (%) | 0 (0.0%) | 2 (11.8%) | - | |
| Induced, n (%) | 8 (47.1%) | 10 (58.8%) | - | |
| Cesarean delivery, n (%) | 9 (52.9%) | 5 (29.4%) | - | |
| Emergency cesarean∗, n (%) | 3 (17.6%) | 1 (5.9%) | 3.00 (0.35-26.04) | |
| Elective cesarean, n (%) | 10 (58.8%) | 9 (52.9%) | 1.11 (0.61-2.02) | |
| Postpartum transfusion, n (%) | 2 (11.8%) | 6 (37.5%) | 0.31 (0.07-1.33) | |
| Proposed composite end point for TAPS3§, n (%) | 10 (58.8%) | 15 (88.2%) | 0.67 (0.43-1.03) | |
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 <16 weeks before the first procedure.
Outcome contributes to proposed composite end point for TAPS3.
Among those with at least 1 admission.
Defined as sickle cell crisis requiring inpatient admission.
Proposed composite end point for future definitive study, ≥1 of: admission for SCD, sickle cell crisis (any report), acute chest syndrome, preeclampsia, venous/pulmonary embolism, and emergency cesarean delivery.