Observational studyHuman vaccines & immunotherapeutics2019
Safety of reduced antigen content diphtheria-tetanus-acellular pertussis vaccine when administered during pregnancy as part of the maternal immunization program in Brazil: a single center, observational, retrospective, cohort study.
Observational study in Human vaccines & immunotherapeutics, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02757950 (A Post-marketing, Observational, Retrospective, Cohort Study to Assess the Safety of RefortrixTM), which is not on this map. Cited by 4 papers.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
A Post-marketing, Observational, Retrospective, Cohort Study to Assess the Safety of RefortrixTM (Tdap) When Administered During Pregnancy in a Maternal Immunization Program in Brazil.
Who cites it
4 citing papers in PubMed, 15 citations in OpenAlex.
- Defining and reporting adverse events of special interest in comparative maternal vaccine studies: a systematic review.Vaccine: X · 2024Review
- Maternal Vaccination to Prevent Adverse Pregnancy Outcomes: An Underutilized Molecular Immunological Intervention?Journal of molecular biology · 2023Review
- Investigating Tetanus, Diphtheria, Acellular Pertussis Vaccination During Pregnancy and Risk of Congenital Anomalies.Infectious diseases and therapy · 2023Article
- Article
Corrections and comments
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Authors and funding
6 authors at 3 institutions in 2 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Reduced antigen diphtheria-tetanus-acellular pertussis (Tdap) vaccination is included in the maternal immunization program in Brazil since September 2014. We investigated associations between maternal Tdap vaccination and pregnancy-related adverse events (AEs) (gestational diabetes, pregnancy-related hypertension, and pregnancy hemorrhage) and neonatal AEs of interest (preterm birth and small for gestational age). This descriptive, observational, retrospective, single-center study in Brazil (NCT02757950) compared data from medical charts of 1203 pregnant women who received Tdap as part of the maternal immunization program and delivered between May 2015 and February 2017 (exposed cohort) and 1259 unvaccinated women who delivered between September 2012 and August 2014 (unexposed cohort). Index dates were defined as the time of vaccination (27-39 gestational weeks; exposed cohort) or 27 gestational weeks (unexposed cohort). Cumulative incidences were calculated as the number of women with each event between index and delivery dates divided by the total number of women with vaccination date available in the exposed cohort (N = 1199) or the total number of women in the unexposed cohort (N = 1259). Cumulative incidences per 1000 persons were 8.34 versus 17.47 for gestational diabetes, 9.17 versus 24.62 for pregnancy-related hypertension, 3.34 versus 15.09 for pregnancy hemorrhage, 53.38 versus 96.11 for preterm birth, and 57.55 versus 49.25 for small for gestational age in the exposed versus unexposed cohorts. No increased risk of pregnancy-related AEs or neonatal AEs of interest was found following maternal vaccination with Tdap. These results should be interpreted cautiously due to limitations inherent to retrospective observational studies.
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Registered trials
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