Community-based follow-up of participants of a mother-friendly clinical trial: A patient-centric methodology for pregnant women.

COMMUNITY health services; ANTIBIOTICS; SEXISM; RESEARCH funding; HUMAN research subjects; STATISTICAL sampling; SECOND trimester of pregnancy; SOCIOECONOMIC factors; PREMATURE infants; BACTERIURIA; TERTIARY care; RANDOMIZED controlled trials; PREGNANCY outcomes; POSTNATAL care; DECISION making; PATIENT-centered care; TELEMEDICINE; PRENATAL care; LOW birth weight; CONFIDENCE intervals; PATIENT aftercare; PATIENT participation; PROPORTIONAL hazards models; PREGNANCY

Repeated visits to clinical trial sites inflict hardships on study participants, especially pregnant women. A newer trend is community-based follow-up for measurements, dosage, or monitoring, through technology or physical visits. We conducted a methodological experiment of performing "community-based physical follow-up" of participants of a trial, receiving facility-based diagnosis and pathogen-specific antibiotics for asymptomatic bacteriuria, guided by an optical-sensor-based rapid point-of-care test. We were able to retain 95.8% participants in the study. Here we describe challenges faced and socio-economic and gender issues encountered in this approach in a low-resource Indian scenario, to guide researchers world-wide for designing mother-friendly clinical trials. [ABSTRACT FROM AUTHOR]

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