OPERATIONAL CHALLENGES AND IMPLEMENTATION BARRIERS IN CONDUCTING A RANDOMIZED DOUBLE-BLIND CLINICAL TRIAL ON ASPIRIN FOR THE PREVENTION OF PRETERM PREECLAMPSIA IN HIGH- RISK PREGNANCIES: EXPERIENCE FROM A TERTIARY CARE TEACHING HOSPITAL

Abstract

Background: Preeclampsia remains a leading cause of maternal and perinatal morbidity and mortality worldwide, particular- ly in low- and middle-income countries. Low-dose aspirin is widely recommended for the prevention of preterm preeclamp- sia in high-risk pregnancies. However, the successful implementation of randomized controlled trials in obstetric populations requires careful coordination of recruitment, adherence monitoring, safety surveillance, and regulatory compliance.

Materials and methods: This manuscript describes the operational challenges encountered during an ongoing randomized, double-blind clinical trial comparing 75 mg and 150 mg aspirin for the prevention of preterm preeclampsia in high-risk preg- nant women at a tertiary-care teaching hospital.

Results: Multiple implementation barriers were identified during trial conduct. Recruitment challenges were primarily related to limited awareness of preeclampsia prevention, concerns regarding medication safety during pregnancy, and socio-economic  constraints  affecting  follow-up  attendance.  Medication  adherence  was  influenced  by  forgetfulness, travel limitations, and misconceptions regarding aspirin use. Regulatory processes required extensive documentation and coordination with institutional oversight bodies. Data management challenges included incomplete documentation and missed follow-up visits. The ongoing study currently reports a loss to follow-up rate of 8.2 percent, with relocation, referral to other facilities, and pregnancy-related complications identified as the most common reasons for attrition.

Conclusion: The experiences documented in this study provide practical insights for investigators conducting maternal health trials and highlight the importance of robust implementation strategies to ensure research quality and participant safety.