The study was done to develop a core outcome set for pre‐eclampsia. The research design that was used for this study was a consensus development study and the scope of the study was international.
281 healthcare professionals, 41 researchers and 110 patients, representing 56 countries, participated in the study. A list of 116 potential core outcomes was developed by combining the outcomes reported in 79 pre‐eclampsia trials with those derived from thematic analysis of 30 in‐depth interviews of women with lived experience of pre‐eclampsia. 47 consensus outcomes were identified from the Delphi process following which 14 maternal and eight offspring core outcomes were agreed upon at the consensus development meeting. Maternal core outcomes: death, eclampsia, stroke, cortical blindness, retinal detachment, pulmonary edema, acute kidney injury, liver hematoma or rupture, abruption, postpartum haemorrhage, raised liver enzymes, low platelets, admission to intensive care required, and intubation and ventilation. Offspring core outcomes: stillbirth, gestational age at delivery, birth weight, small‐for‐gestational‐age, neonatal mortality, seizures, admission to a neonatal unit required, and respiratory support.
The study concluded that the core outcome set for pre‐eclampsia should underpin future randomized trials and systematic reviews.