Maternal and neonatal safety outcomes after SAR-CoV-2 vaccination during pregnancy: a systematic review and meta-analysis.

ABSTRACT

BACKGROUND AND OBJECTIVE: More than five million individuals died because of problems connected to COVID-19. SARS-Cov-2 poses a particular challenge to expectant mothers, who comprise one of the most vulnerable segments of the population. Our aim is to demonstrate the maternal and neonatal safety of the COVID-19 vaccine during pregnancy. METHODS: We searched PubMed, Cochrane Library, Scopus, Web of Science (WOS), Embase, Ovid, MedRxiv, and BioRxiv databases from inception till December 2021 and then updated it in April 2022. Additionally, we searched ClinicalTrials.gov, Research Square and grey literature. Cohort, case-control studies, and randomized controlled trials detecting the safety of the Covid-19 vaccine during pregnancy were included. We used the Cochrane tool and Newcastle-Ottawa Scale to assess the risk of bias of the included studies and the GRADE scale to assess the quality of evidence. A meta-analysis was conducted using review manager 5.4. RESULTS: We included 13 studies with a total number of 56,428 patients. Our analysis showed no statistically significant difference in the following outcomes: miscarriage (1.56% vs 0.3%. RR 1.23; 95%CI 0.54 to 2.78); length of maternal hospitalization (MD 0.00; 95%CI -0.08 to 0.08); puerperal fever (1.71% vs 1.1%. RR 1.04; 95%CI 0.67 to 1.61); postpartum hemorrhage (4.27% vs 3.52%. RR 0.84; 95%CI 0.65 to 1.09); instrumental or vacuum-assisted delivery (4.16% vs 4.54%. RR 0.94; 95%CI 0.57 to 1.56); incidence of Apgar score ≤ 7 at 5 min (1.47% vs 1.48%. RR 0.86; 95%CI 0.54 to 1.37); and birthweight (MD -7.14; 95%CI -34.26 to 19.99). CONCLUSION: In pregnancy, the current meta-analysis shows no effect of SAR-CoV-2 vaccination on the risk of miscarriage, length of stay in the hospital, puerperal fever, postpartum hemorrhage, birth weight, or the incidence of an Apgar score of ≤ 7 at 5 min.