Transfusion requirements after postpartum hemorrhage: a randomized controlled trial - WOMB Study

Background

In acute anemia, the triggers for red blood cell (RBC) transfusion are controversial. We performed a randomized controlled trial to determine whether expectant management was non-inferior to RBC transfusion in postpartum patients with acute anemia. We compared physical fatigue at day three postpartum and physical complications during follow-up.

Methods

Between May 2004 and February 2011 we enrolled 521 patients with anemia (Hb 4.8-7.9g/dL) after postpartum hemorrhage (PPH), without severe anemic complaints. We randomly assigned 259 patients to RBC transfusion and 262 to expectant management. Four hundred fifteen patients refused randomization but were willing to complete questionnaires. Primary outcome was physical fatigue (Multidimensional Fatigue Inventory, scale 4-20, 20 represents maximal fatigue) three days postpartum. Health related quality of life was assessed at five time points until six weeks postpartum. Physical complications and transfusion reactions were recorded.

Results

A median of two units of RBCs was transfused in the RBC transfusion group and none in the expectant management group. Mean physical fatigue at day three postpartum, adjusted for baseline value and mode of delivery, was 0.8 higher in patients randomized to expectant management (95% CI: 0.1-1.5, P = 0.024) and the maximal difference was 1.06 one week postpartum. Transfusion reactions occurred only in the RBC transfusion arm group (1%). Physical complications were comparable between study groups.

Conclusion

In patients with acute anemia after PPH, the rise in Hb concentration by RBC transfusion only slightly improves physical fatigue and should therefore not be applied routinely in women with anemia after PPH.

Study design: RCT
Study population: 521
Study endpoint: non inferiority study

Inclusion criteria:
Exclusion criteria:

Investigators  

BW Prick
GJ Jansen

Projectleaders

JJ Duvekot
DJ van Rhenen

Contact

EMC dept. of Obstetrics and Gynecology
Dept. of Transfusion Medicine Sanquin Rotterdam

Last edited on: 21 July 2016