Zinah Sorefan, CROWN Project Coordinator.
Randomised clinical trials (RCTs) and systematic reviews have to measure endpoints that are relevant and meaningful to patients, clinicians, and health service providers alike. Recently, it was found that there was a lack of consistency in the choice and definitions of primary outcomes in clinical research: systematic reviews of preventative interventions for preterm birth included 103 RCT’s in which 72 different primary outcomes were used. Therefore, there was a need to develop core outcome sets for studies focusing on prevention of preterm birth in high-risk women.
228 international stakeholders (obstetricians, neonatologist, midwives, patients and researchers/journal editors) from middle to high-income countries were invited to participate in the process of selection of outcomes and quality assessment using an online survey according to a Delphi methodology.
Following this survey, the stakeholders reached a consensus on 13 core outcomes which can ensure that data from trials that assess prevention of preterm birth can be compared and combined.
The Core Outcomes for prevention of preterm birth are categorised below.
Four are related to pregnant women:
- maternal mortality
- maternal infection or inflammation
- prelabour rupture of membranes
- harm to the mother from intervention.
Nine are related to offspring:
- gestational age at birth,
- offspring mortality,
- birth weight,
- early neurodevelopmental morbidity,
- late neurodevelopmental morbidity,
- gastrointestinal morbidity,
- respiratory morbidity
- harm to offspring from intervention.
About preterm birth research:
Research into premature birth focuses on infants born before 37 weeks gestation (a ‘normal’ gestational period can last anywhere between 38 – 42 weeks). The effect of premature birth on the developmental outcome of the infant into childhood and beyond is very important to understand. This is because the brain development of the foetus throughout pregnancy is incredibly complex, especially in the third trimester whereby growth and changes are extremely rapid. In a healthy mother, the richly nutritious, oxygenated and protective environment of the womb provides all the essentials for this proper development to take place. Therefore, it makes sense that premature delivery may create some difficulties for the infant, depending on how early they are born and the circumstances surrounding their birth.