A Randomized Controlled Field Trial of the Efficacy of a Simplified Maternal Immunization Schedule in Reducing Neonatal Tetanus Deaths in Rural Sierra Leone

Abstract

<p>The purpose of this thesis is to describe a research strategy for evaluating the efficacy of a reduced dose maternal tetanus immunization schedule in reducing neonatal tetanus deaths in Sierra Leone.</p> <p>Neonatal tetanus has been demonstrated to be a major cause in infant death in areas where sanitary midwifery is unavailable. A review of the literature reveals evidence for reduction in neonatal tetanus deaths by maternal immunization using a conventional three dose adsorbed tetanus toxoid.</p> <p>In Sierra Leone, as in many developing countries, the resources are unavailable to maintain a three-dose schedule in the relatively inaccessible interior of the country. A two-dose schedule of a concentrated adsorbed toxoid has been recommended as an alternative by the World Health Organization. Research on simplified immunization schedules has been reviewed; the results are inconclusive.</p> <p>A double-blind randomized placebo-controlled design has been selected to address the research questions. Various aspects of this design are discussed with respect to methodologic and ethical issues.</p> <p>Procedures for carrying out the trial and for the assessment of neonatal tetanus death in a remote chiefdom in Sierra Leone are proposed. A procedure for the analysis of outcome data is presented.</p>