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

Health Care Women Int. 2024;45(6):694-707. doi: 10.1080/07399332.2021.1967355. Epub 2021 Oct 11.

Abstract

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.

Publication types

  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adult
  • Anti-Bacterial Agents / therapeutic use
  • Female
  • Follow-Up Studies
  • Humans
  • India
  • Mothers / psychology
  • Patient-Centered Care
  • Pregnancy
  • Pregnant Women* / psychology
  • Socioeconomic Factors

Substances

  • Anti-Bacterial Agents