Koshy 1988.
Methods | Randomised controlled trial. | |
Participants | 72 pregnant women diagnosed with sickle cell anaemia presenting in early pregnancy without other medical disorders. Exclusion criteria: women previously on long‐term prophylactic transfusion beginning before the study; pregnant women with other haemoglobinopathies such as HbSC and HbSβ‐Thalassaemia. Setting: 6 hospitals in Chicago (secondary and university hospitals) and Johns Hopkins Hospital, Baltimore. |
|
Interventions | Intervention: red cell transfusion at the beginning of the management of their pregnancy with the goal of maintaining Hb concentration at 10 g/dL and 11 g/dL, or the HCT near 0.33, and to reduce the HbS below 35% by simple transfusion or partial exchange transfusion. Immediately upon entry into the study, patients received 2 units of packed washed frozen red cells weekly for 3 weeks or until the above goals were reached. All blood transfused was obtained from volunteer donors and processed according to standard blood banking procedures (n = 36). Control: blood transfusion only for medical or obstetric indications. Haematologic indication for blood transfusion were a Hb concentration below 6 g/dL, a HCT below 18% and a reticulocyte count below 3%. All blood transfused was obtained from volunteer donors and processed according to standard blood banking procedures (n = 36). |
|
Outcomes | Maternal death, severe maternal morbidity (acute chest syndrome, pulmonary embolism, congestive heart failure), perinatal death, pain crisis, total units of blood transfused, blood transfusion reaction. | |
Notes | The study was conducted over a period of 7 years and 2 months. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Method of random sequence generation not stated. Study was described as "controlled randomized prospective study…". Patients were random assigned to 1 of 2 treatments. |
Allocation concealment (selection bias) | Unclear risk | No information about allocation concealment to permit judgement. |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Although it is impracticable to blind participants and key study personnel to intervention, the knowledge of the intervention by the study personnel makes performance bias a high possibility. |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Uncertain whether outcome assessors were blinded. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | No missing data reported. |
Selective reporting (reporting bias) | Unclear risk | Comparison of outcome measure in the 'Methods' and 'Results; sections of the report indicated no evidence of selective outcome reporting although there was a reference to occurrence of maternal mortality in the 'Discussion' section. |
Other bias | Unclear risk | The significant difference in previous perinatal mortality (as one of the baseline characteristics) between intervention and control groups questions the effectiveness of the randomisation procedures. |
Hb: haemoglobin HCT: haematocrit