Grant: Operating Grant: SPOR Innovative Clinical Trial Multi-Year Grant - LOI

Premature birth is a quintessential example of a condition that is better to prevent than treat. While important advances in neonatal care have reduced mortality and improved some outcomes, preterm birth remains a major cause of morbidity and mortality. We propose a pilot 2 x 2 factorial randomized controlled trial of an intervention aimed at preventing premature births. The PICO summary of the trial is: Population: Pregnant patients who have trouble affording basic necessities ("making ends meet") and who are at elevated risk of preterm birth due to either a prior premature singleton birth (<37 weeks) or smoking and nulliparity. Interventions: (1) a $100 per month income supplement and (2) midwifery-led care including screening and treatment of genital tract infections and smoking cessation. Comparator: Usual care and supports Outcomes: Primary outcome: Gestational age at birth Secondary outcomes: Any preterm birth; each mutually exclusive subcategory of premature birth including extremely preterm (less than 28 weeks), very preterm (28 to 31 weeks+6 days), moderate to late preterm (32 to 36 weeks+6 days); term birth; post-term; stillbirth; and pregnancy loss