1 Roos N, et al. BMJ Open 2019;9:e024449. doi:10.1136/bmjopen-2018-024449 Open access Maternal Immunization and Antenatal Care Situation Analysis (MIACSA) study protocol: a multiregional, cross- sectional analysis of maternal immunization delivery strategies to reduce maternal and neonatal morbidity and mortality Nathalie Roos, 1 Philipp Lambach, 2 Carsten Mantel, 3,4 Elizabeth Mason, 5 Flor M Muñoz, 6 Michelle Giles, 7 Allisyn Moran, 1 Joachim Hombach, 2 Theresa Diaz, 1 MIACSA expert advisory panel group To cite: Roos N, Lambach P, Mantel C, et al. Maternal Immunization and Antenatal Care Situation Analysis (MIACSA) study protocol: a multiregional, cross-sectional analysis of maternal immunization delivery strategies to reduce maternal and neonatal morbidity and mortality. BMJ Open 2019;9:e024449. doi:10.1136/ bmjopen-2018-024449 ► Prepublication history for this paper is available online. To view these fles, please visit the journal online (http://dx.doi. org/10.1136/bmjopen-2018- 024449). Received 26 May 2018 Revised 8 February 2019 Accepted 6 March 2019 For numbered affliations see end of article. Correspondence to Dr Nathalie Roos; roosn@who.int Protocol © Author(s) (or their employer(s)) 2019. Re-use permitted under CC BY. Published by BMJ. ABSTRACT Introduction Maternal immunization (MI) with tetanus toxoid containing vaccine, is a safe and cost-effective way of preventing neonatal tetanus. Given the prospect of introducing new maternal vaccines in the near future, it is essential to identify and understand current policies, practices and unmet needs for introducing and/or scaling up MI in low-income and middle-income countries (LMICs). Methods and analysis The Maternal Immunization and Antenatal Care Situation Analysis (MIACSA) is a mixed methods, cross-sectional study that will collect data in four phases: (1) a review of global databases for selected health indicators in 136 LMICs; (2) a structured online survey directed at Maternal, Newborn and Child Health and Expanded Programme on Immunization focal points in all 136 LMICs; (3) semistructured telephone interviews of 30 selected LMICs and (4) 10 week-long country visits, including key informant interviews, health facility visits and focus group discussions. The principal analyses will assess correlations between the various aspects of MI delivery strategies and proxy measures of health systems performance related to vaccine-preventable disease control. The primary outcome will be a typology of existing MI delivery models, and secondary outcomes will include country profles of child and maternal health indicators, and a MI gaps and needs analysis. Ethics and dissemination The protocol was approved by the WHO Ethics Review Committee (ERC.0002908). The results will be made available in a project report and submitted for publication in peer-reviewed journals that will be shared broadly among global health decision- makers, researchers, product developers and country-level stakeholders. INTRODUCTION Vaccine-preventable diseases are a major cause of global child morbidity and mortality, particularly in low-income and middle-income countries (LMICs). 1 Since the 1990s, public health interventions have more than halved under-five childhood mortality; however, reduction of stillbirths and of neonatal mortality (death in the first 28 days of life) has been slower. 2 This is in part due to the fact that most vaccines cannot be administered to newborns, who, being unable to develop protective responses due to limitations in their immune system, are left particularly vulnerable to infectious diseases. Vaccination of pregnant women, or maternal immunization (MI) with tetanus toxoid containing vaccine, has proven Strengths and limitations of this study ► The Maternal Immunization and Antenatal Care Situation Analysis (MIACSA) study provides a frst time, comprehensive global overview and analy- sis of existing maternal immunization (MI) delivery strategies in low-income and middle-income coun- tries (LMICs). ► The study benefts from a mixed-methods design; a multidisciplinary approach leveraging policy-level, academic and implementers’ experience. ► Limitations include the small number of countries and healthcare facilities visited within each country included in the study, precluding generalisation of country visit fndings to a national level. ► End-users’ perspective is captured only indirectly through community health workers. Data on MI ser- vice delivery collected through an online survey tar- geting all LMICs are analysed within the limitations of the validity of data collected. on April 24, 2020 by guest. Protected by copyright. http://bmjopen.bmj.com/ BMJ Open: first published as 10.1136/bmjopen-2018-024449 on 4 June 2019. Downloaded from