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Randomized trials evaluating interventions for asymptomatic preterm birth have reported many different outcomes leading to an inability to synthesize evidence across studies. A core outcome set, an agreed standard set of outcomes that should be measured and reported as a minimum in all effectiveness trials in this specific health area, has been developed using robust consensus methods with input from CROWN journals ( acting as a stakeholder group (van't Hooft et al., 2016).


In total, five stakeholder groups, including parents (n=25), midwives (n=25), obstetricians (n=55), neonatologists (n=34), and researchers (n=35) from 25 countries, participated in a web-based Delphi survey. Outcomes entered into the Delphi survey were identified by systematic literature review (227 outcomes) and suggested by individual stakeholders (33 outcomes).


Survey participants scored each outcome on a 9-point Likert scale anchored between 1 (limited importance) and 9 (critical importance). They had the opportunity to reflect upon total and stakeholder subgroup feedback between survey stages. For consensus, defined a priori, outcomes required at least 70% of participants of each stakeholder group to score them as "critical" and less than 15% as "limited."


Consensus was reached on 13 core outcomes. Four were related to pregnant women: 1) maternal mortality; 2) maternal infection or inflammation; 3) prelabor rupture of membranes; and 4) harm to mother from intervention. Nine were related to the offspring: 1) gestational age at birth; 2) offspring mortality; 3) birth weight; 4) early neurodevelopmental morbidity; 5) late neurodevelopmental morbidity; 6) gastrointestinal morbidity; 7) infection; 8) respiratory morbidity; and 9) harm to offspring from intervention.


The idea behind this core outcome set is that by using and reporting common data our specialty will be able to facilitate data sharing among studies, optimizing the scientific value of research and its applicability in practice for the benefit of women and their offspring.




van't Hooft J., Duffy J. M., Daly M., Williamson P. R., Meher S., Thom E., ..., Khan K. S.for the Global Obstetrics Network (GONet). ( 2016). A core outcome set for evaluation of interventions to prevent preterm birth. Obstetrics and Gynecology, 127(1), 49-58. doi: 10.1097/AOG.0000000000001195