Perinatal Mortality Outcomes Through Household Infection Pathways

The goal of this trial is to learn if replacing household soil floors with concrete floors can prevent deaths of infants around the time of birth, including stillbirths and deaths in the first month of life in rural Bangladesh. The primary question the study aims to answer is: Does residing in a home with a concrete vs. soil floor reduce the perinatal and neonatal morality in index children and their younger siblings up to 6 years post-installation of concrete floors? Researchers will compare participants in households with concrete floors (intervention) vs. soil floors (comparison group) to see if concrete floors reduce the rate of perinatal death and child death up the 6 years post-intervention. This study will extend an ongoing NIH-funded randomized trial in which households with soil floors where a pregnant woman resided were randomly chosen to receive a concrete floor intervention or to retain their existing soil floor. This study will track pregnancies, births, and deaths among infants born to pregnant mothers in the original study to measure effects of household concrete flooring up to 6 years after the concrete floors were installed.

NCT Number	NCT07620613
Lead Sponsor	Stanford University Collaborators: Thrasher Research Fund, International Centre for Diarrhoeal Disease Research, Bangladesh, North Carolina State University, Directorate General of Health Services, Bangladesh
Conditions	Stillbirth and Neonatal Mortality, Perinatal Mortality, Infant Mortality, Child Mortality
Enrollment	196 participants
Start Date	2026-06-01
Primary Completion	2029-03-01 (estimated)
Study Completion	2029-05-01 (estimated)
Updated on ClinicalTrials.gov	2026-07-01