How to define postpartum haemorrhage?
Patients are eligible for inclusion in the WOMAN Trial if they have a clinical diagnosis of PPH. Patients can be included if the doctor considers that there has been a blood loss of more than 500 ml after vaginal delivery or 1000 ml after caesarean, or if they consider that the blood loss is sufficient to compromise the haemodynamic status of the woman. It is entirely appropriate that trial entry is based on a clinical assessment of bleeding, since should the treatment be proven to be effective, this is how the treatment will be used. If the clinician’s diagnosis of postpartum bleeding at a particular hospital is based on some standardised measure of blood loss, such as the use of calibrated drapes, then this may be used to guide trial entry. However, since there is no uniformly accepted method of assessing blood loss it would be inappropriate to insist on any particular approach in this trial as the trial is designed to assess the effect of tranexamic acid in the context of normal cli
