WOMAN-2 Pilot Study Data

Data and supporting material produced as part of a pilot study to test outcome questions for the WOMAN-2 trial of tranexamic acid for the prevention of postpartum haemorrhage. This pilot study was conducted in one hospital which will also be conducting the WOMAN-2 Trial in Pakistan. The pilot study population included participants similar to those to be included in the WOMAN-2 Trial: women who are anaemic, and having given birth. Participants took part in an interview which included answering questions from the draft participant reported outcomes questionnaire. A small subset of participants enrolled in this pilot study also took part in a cognitive interview directly following the questionnaire to learn how they understood the questions. Each row of the dataset table represents data for an individual participant

Development of a patient reported outcome questionnaire to measure the impact of postpartum blood loss in women with moderate and severe anaemia: A study using a multi-faceted approach

Background: Globally, over one-third of pregnant women are anaemic and are at increased risk of postpartum haemorrhage (PPH).  Tranexamic acid (TXA) given within 3 hours of birth significantly reduces death due to bleeding in women with PPH. However, for many, treatment is too late to prevent death from PPH. The WOMAN-2 trial aims to see if giving TXA can prevent PPH and other outcomes in women with moderate and severe anaemia. Assessing the impact of postpartum blood loss on women’s own perceptions of their health and well-being is an important outcome for the WOMAN-2 trial. This study aimed to develop a conceptual framework and questionnaire to measure the impact of postpartum blood loss on participant-reported outcomes (PRO) in women with moderate and severe anaemia. Methods: A conceptual framework and PRO questionnaire were developed using a multifaceted, iterative process. Factors influencing anaemic women’s postpartum experience were identified from review of the literature and through group discussion with them. De novo items were combined with those from an existing instrument (Multi-dimensional Fatigue Symptom Inventory, Short Form (MFSI-SF)). Content validity was tested among a group of obstetricians and anaemic postpartum women, revised and then pilot tested among 124 women with moderate and severe anaemia following vaginal birth.  Results: Women with moderate and severe anaemia who experienced PPH reported more fatigue on the MFSI-SF (p=0.001); reported feeling more ill (p=0.004); and had greater difficulty breastfeeding (p=0.039), compared to those who did not experience PPH. Compared to women with moderate anaemia, women with severe anaemia reported experiencing worse symptoms of anaemia (p=0.001) and scored worse on the MFSI-SF (p=0.007). Conclusions: Significant differences between the scores of women who developed PPH and those who did not and the scores between women with moderate and severe anaemia indicate that the questionnaire had satisfactory construct validity