Trial reportPloS one2012
Low rate of pandemic A/H1N1 2009 influenza infection and lack of severe complication of vaccination in pregnant women: a prospective cohort study.
Trial report in PloS one, 2012. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01192737 (Cohort Study to Evaluate Clinical Expression and Maternofetal Consequences of A/H1N1 Influenza in Pregnant Women), which is not on this map. Cited by 12 papers, 6 of them syntheses that pooled it.
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.
Cohort Study to Evaluate Clinical Expression and Maternofetal Consequences of A/H1N1 Influenza in Pregnant Women
Who cites it
12 citing papers in PubMed, 6 syntheses or guidelines pooled it, 28 citations in OpenAlex.
- Pooled it
- The safety of inactivated influenza vaccines in pregnancy for birth outcomes: a systematic review.Human vaccines & immunotherapeutics · 2019Pooled it
- Intensive Monitoring Studies for Assessing Medicines: A Systematic Review.Frontiers in medicine · 2019Pooled it
- Vaccines for preventing influenza in healthy adults.The Cochrane database of systematic reviews · 2018Pooled it
- A systematic review of ethical issues in vaccine studies involving pregnant women.Human vaccines & immunotherapeutics · 2016Pooled it
- A systematic review of adverse events following immunization during pregnancy and the newborn period.Vaccine · 2015Pooled it
- Trivalent influenza vaccination randomized control trial of pregnant women and adverse fetal outcomes.Vaccine · 2019Trial
- Evaluating the Protective Effects of Influenza Vaccination in Pregnant Women and Their Infants: An Umbrella Review.Iranian journal of public health · 2025Review
- Article
- Maternal vaccination for the prevention of influenza: current status and hopes for the future.Expert review of vaccines · 2016Review
- Review on the effects of influenza vaccination during pregnancy on preterm births.Human vaccines & immunotherapeutics · 2015Review
- Predictive factors of cytomegalovirus seropositivity among pregnant women in Paris, France.PloS one · 2014Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
14 authors at 6 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundIn 2009, pregnant women were specifically targeted by a national vaccination campaign against pandemic A/H1N1 influenza virus. The objectives of the COFLUPREG study, initially set up to assess the incidence of serious forms of A/H1N1 influenza, were to assess the consequences of maternal vaccination on pregnancy outcomes and maternal seroprotection at delivery.
methodsPregnant women, between 12 and 35 weeks of gestation, non vaccinated against A/H1N1 2009 influenza were randomly selected to be included in a prospective cohort study conducted in three maternity centers in Paris (France) during pandemic period. Blood samples were planned to assess hemagglutination inhibition (HI) antibody against A/H1N1 2009 influenza at inclusion and at delivery.
resultsAmong the 877 pregnant women included in the study, 678 (77.3%) had serum samples both at inclusion and delivery, and 320 (36.5%) received pandemic A/H1N1 2009 influenza vaccine with a median interval between vaccination and delivery of 92 days (95% CI 48-134). At delivery, the proportion of women with seroprotection (HI antibodies titers against A/H1N1 2009 influenza of 1∶40 or greater) was 69.9% in vaccinated women. Of the 422 non-vaccinated women with serological data, 11 (2.6%; 95%CI: 1.3-4.6) had laboratory documented A/H1N1 2009 influenza (1 with positive PCR and 10 with serological seroconversion). None of the 877 study's women was hospitalized for flu. No difference on pregnancy outcomes was evidenced between vaccinated women, non-vaccinated women without seroconversion and non-vaccinated women with flu.
conclusionDespite low vaccine coverage, incidence of pandemic flu was low in this cohort of pregnant women.No effect on pregnancy and delivery outcomes was evidenced after vaccination.
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