Transfusion policy after severe postpartum haemorrhage: a randomised non‐inferiority trial

Abstract

Objective To assess the effect of red blood cell (RBC) transfusion on quality of life in acutely anaemic women after postpartum haemorrhage.Design Randomised non-inferiority trial.Setting Thirty-seven Dutch university and general hospitals.Population Women with acute anaemia (haemoglobin 4.8-7.9 g/dl [3.0-4.9 mmol/l] 12-24 hours postpartum) without severe anaemic symptoms or severe comorbidities.Methods Women were allocated to RBC transfusion or non-intervention.Main outcome measures Primary outcome was physical fatigue 3 days postpartum (Multidimensional Fatigue Inventory, scale 4-20; 20 represents maximal fatigue). Non-inferiority was demonstrated if the physical fatigue difference between study arms was maximal 1.3. Secondary outcomes were health-related quality of life and physical complications. Health-related quality of life questionnaires were completed at five time-points until 6 weeks postpartum.Results In all, 521 women were randomised to non-intervention (n = 262) or RBC transfusion (n = 259). Mean physical fatigue score at day 3 postpartum, adjusted for baseline and mode of delivery, was 0.8 lower in the RBC transfusion arm (95% confidence interval: 0.1-1.5, P = 0.02) and at 1 week postpartum was 1.06 lower (95% confidence interval: 0.3-1.8, P = 0.01). A median of two RBC units was transfused in the RBC transfusion arm. In the non-intervention arm, 33 women received RBC transfusion, mainly because of anaemic symptoms. Physical complications were comparable.Conclusions Statistically, non-inferiority could not be demonstrated as the confidence interval crossed the non-inferiority boundary. Nevertheless, with only a small difference in physical fatigue and no differences in secondary outcomes, implementation of restrictive management seems clinically justified.

National and International Guidelines for Patient Blood Management in Obstetrics: A Qualitative Review

“…67–70 These results have not been confirmed in the obstetric setting. In a randomized, nonblinded study to assess the effect of RBC transfusion versus no intervention on the maternal quality of life among women with PPH and early postpartum anemia (Hb 4.8–7.9 g/dL 12- to 24-hours postpartum), Prick et al 71 did not demonstrate non-inferiority with the non-RBC-based approach. However, on postpartum day 3, the authors noted that women in the no intervention group only had a 0.78 higher mean physical fatigue score compared with those receiving RBC (physical fatigue scores range from 4 to 20; higher scores indicating more fatigue).…”

Major obstetric hemorrhage: a follow-up survey on quality of life of women and their partners

“…A recent study of Prick et al described QOL in the 6 weeks after PPH in women with or without blood transfusion [35]. Transfused women scored better on fatigue scales and marginally better on the RAND-36.…”

The impact of postpartum hemoglobin levels on maternal quality of life after delivery: a prospective exploratory study

“…[12] In a different study, Prick et al assessed women with severe postpartum anemia who were randomized to receive red blood cells or no transfusion. [26] At one week postpartum, women in the non-intervention group had lower physical functioning HRQoL scores and higher fatigue scores compared to those receiving transfusion. However, these between-group differences were relatively small: 5.5 point difference in the SF-36 physical functioning score (scores range from 0 to 100), and a 1.1 point difference in MFI physical fatigue score (scores range from 4 to 20).…”

“…In contrast, in the study by Jansen et al[12], the minimum and maximum Hb levels after vaginal delivery were 7 g/dl and 15 g/dl respectively, with Hb levels assessed at 12–24 hours after vaginal delivery or 24–48 hours after cesarean delivery. Prick et al[26] recruited women with severe postpartum anemia (Hb levels between 4.8–7.9 g/dl) between 12 – 24 hours postpartum. Van Der Woude et al enrolled women who had Hb levels measured within 48 hours of delivery.…”