Lessons learnt from enrolment and follow up of pregnant women and their infants in clinical trials in South Africa, a low-middle income country.

摘要: Abstract Introduction Infectious causes are a significant contributor to morbidity and mortality in neonates young infants. Immunization of pregnant women protect the mother and/or her infant is gaining momentum due benefits this strategy demonstrated numerous implemented strategies (Maternal Neonatal Tetanus Elimination Initiative) clinical trials. Reluctance by regulators, participants healthcare providers include trials considerable, but reducing. disease burden, therefore need for interventions reduce mothers infants, highest low-middle income countries (LMIC), however, reliable background data on adverse pregnancy outcomes lack experience community opinions immunization during not well documented. Methods We used our experiences conducting two studies South Africa illustrate challenges experienced lessons learnt which may benefit others working maternal field. Results Accurate gestational age assessment, essential trials, challenging LMIC limited access early ultrasound examinations, unreliable assessment history (last menstrual period date) physical examination (symphyseal-fundal height). Concomitant administration recommended vaccines has previously been avoided trials; limitation could impact potentially beneficial that can antenatal care. Women have higher burden concomitant illnesses (e.g. HIV infection, malaria anaemia) stillbirth) than countries. Availability local safety monitoring committees identify vaccine-related event triggers. Conclusion them their infants promising, high-risk settings should be included (Clinical trial registry number: ‘Study A’: NCT01193920 , B’: NCT01888471 ).