Perinatal Mortality Outcomes Through Household Infection Pathways

This study extends follow-up of an interventional, randomized controlled trial that enrolled 800 households in rural Bangladesh with soil floors where a pregnant woman resided and randomized them 1:1 to receive a concrete floor or keep their existing soil floor (Cement flooRs AnD chiLd hEalth (CRADLE), NCT05372068). The original trial installed concrete floors in the intervention arm during their pregnancy and will measure the primary endpoint when children born to enrolled pregnant women (i.e., index children) reach age 2 years. This study extends follow-up to up to 6 years after concrete floors were installed to measure perinatal and child mortality among all children born to CRADLE-enrolled mothers during the study period, including index children and children born in subsequent pregnancies. For subsequent pregnancies occurring during the study period, research staff will visit study homes in the perinatal period to ascertain birth outcomes and child deaths. For index children previously enrolled in the CRADLE trial, research staff will ascertain child deaths by phone once per year. For each death identified during the study period, research staff will perform verbal and social autopsy, and cause of death will be classified using the International Classification of Diseases, 11th Revision (ICD-11).

Inclusion criteria

• Prior enrollment in the CRADLE trial (NCT05372068), in either arm, and currently residing in the original CRADLE-enrolled household
• Residence in Sirajganj or Tangail districts in Bangladesh
• No major non-compliance (e.g., no removal of concrete floor in intervention arm or installation of concrete floor in control arm)
• No plan to relocate within the study follow-up period
• Incident pregnancy occurring after CRADLE trial enrollment, confirmed after 26 weeks gestation