A systematic review and meta-analysis protocol on the association of malaria in pregnancy and adverse birth outcomes

Introduction Malaria in pregnancy contributes to significant adverse birth outcomes. This study is aimed to quantify the relationship between malaria in pregnancy and occurrence of adverse birth outcomes, including preterm delivery, low birth weight, small for gestational age, miscarriages, and stillbirth. Methods and analysis Observational studies and Randomised controlled trials reporting data on selected birth outcomes separately for pregnancies, with or without malaria will be included. We will search for studies over various information sources and data extraction will be done from included studies. Pooled odds ratio (OR) will be calculated for each birth outcomes using fixed effect model or random effects models, based on the level of heterogeneity. Forest plot will be prepared with effect size (with 95 percent confidence interval) of each study and pooled effect size. The methodological quality will be assessed for included observational studies using the Newcastle-Ottawa scale (NOS). Cochrane Risk of Bias tool will be used to evaluate bias in randomised controlled trials. For publication bias, funnel plot will be prepared and assessed for asymmetry, along with Egger’s test. Discussion This study will provide an estimate of the risk of adverse birth outcomes in pregnancies with malaria. Results of this study will contribute towards planning effective service delivery in areas with a higher risk of malaria transmission. Ethics and dissemination The current study is a review of published literature, and it does not require ethical committee approval. Results of this review will be published in a peer-reviewed journal. PROSPERO registration number CRD42020153009 Strengths and limitations of this study ### Competing Interest Statement The authors have declared no competing interest. ### Funding Statement This research received no specific grant from any funding agency in the public, commercial or not-for-profit sectors. ### Author Declarations I confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained. Yes The details of the IRB/oversight body that provided approval or exemption for the research described are given below: Current study a is review of published literature, and it does not require ethical committee approval. All necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived. Yes I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance). Yes I have followed all appropriate research reporting guidelines and uploaded the relevant EQUATOR Network research reporting checklist(s) and other pertinent material as supplementary files, if applicable. Yes None