Observational studyBMJ (Clinical research ed.)2014
Safety of pertussis vaccination in pregnant women in UK: observational study.
Observational study in BMJ (Clinical research ed.), 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 97 papers, 12 of them syntheses that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
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.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
97 citing papers in PubMed, 12 syntheses or guidelines pooled it, 282 citations in OpenAlex.
- Pooled it
- Vaccination dropout among children in Sub-Saharan Africa: Systematic review and meta-analysis.Human vaccines & immunotherapeutics · 2022Pooled it
- Safety and effectiveness of acellular pertussis vaccination during pregnancy: a systematic review.BMC infectious diseases · 2020Pooled it
- Limitations for health research with restricted data collection from UK primary care.Pharmacoepidemiology and drug safety · 2019Pooled it
- Guideline
- Prevention of Pertussis, Tetanus, and Diphtheria with Vaccines in the United States: Recommendations of the Advisory Committee on Immunization Practices (ACIP).MMWR. Recommendations and reports : Morbidity and mortality weekly report. Recommendations and reports · 2018Guideline
- Guideline
- Guideline
- Efficacy and safety of pertussis vaccination for pregnant women - a systematic review of randomised controlled trials and observational studies.BMC pregnancy and childbirth · 2017Pooled it
- Preterm birth: Case definition & guidelines for data collection, analysis, and presentation of immunisation safety data.Vaccine · 2016Guideline
- Neonatal death: Case definition & guidelines for data collection, analysis, and presentation of immunization safety data.Vaccine · 2016Guideline
- Guideline for collection, analysis and presentation of safety data in clinical trials of vaccines in pregnant women.Vaccine · 2016Guideline
- Trial
- A phase IV, multi-centre, randomized clinical trial comparing two pertussis-containing vaccines in pregnant women in England and vaccine responses in their infants.BMC medicine · 2021Trial
- Robust Humoral and Cellular Immune Responses to Pertussis in Adults After a First Acellular Booster Vaccination.Frontiers in immunology · 2018Trial
- Randomized clinical trial of the safety and immunogenicity of the Tdap vaccine in pregnant Mexican women.Human vaccines & immunotherapeutics · 2017Trial
- Under-recognized pertussis in adults from Asian countries: a cross-sectional seroprevalence study in Malaysia, Taiwan and Thailand.Epidemiology and infection · 2016Trial
- Biometric Strategies to Improve Vaccine Immunogenicity and Effectiveness.Biomimetics (Basel, Switzerland) · 2025Review
- Risk signal assessment of Tdap vaccine use alone by pregnant women: An updated pharmacoepidemiological study.Frontiers in cellular and infection microbiology · 2025Article
- Review
37 more citing papers are in PubMed but not listed here.
Corrections and comments
- Commented on by
Authors and funding
3 authors at 1 institution in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
objectiveTo examine the safety of pertussis vaccination in pregnancy.
designObservational cohort study.
settingThe UK Clinical Practice Research Datalink.
participants20,074 pregnant women with a median age of 30 who received the pertussis vaccine and a matched historical unvaccinated control group.
main outcome measureAdverse events identified from clinical diagnoses during pregnancy, with additional data from the matched child record identified through mother-child linkage. The primary event of interest was stillbirth (intrauterine death after 24 weeks' gestation).
resultsThere was no evidence of an increased risk of stillbirth in the 14 days immediately after vaccination (incidence rate ratio 0.69, 95% confidence interval 0.23 to 1.62) or later in pregnancy (0.85, 0.44 to 1.61) compared with historical national rates. Compared with a matched historical cohort of unvaccinated pregnant women, there was no evidence that vaccination accelerated the time to delivery (hazard ratio 1.00, 0.97 to 1.02). Furthermore, there was no evidence of an increased risk of stillbirth, maternal or neonatal death, pre-eclampsia or eclampsia, haemorrhage, fetal distress, uterine rupture, placenta or vasa praevia, caesarean delivery, low birth weight, or neonatal renal failure, all serious events that can occur naturally in pregnancy.
conclusionIn women given pertussis vaccination in the third trimester, there is no evidence of an increased risk of any of an extensive predefined list of adverse events related to pregnancy. In particular, there was no evidence of an increased risk of stillbirth. Given the recent increases in the rate of pertussis infection and morbidity and mortality in neonates, these early data provide initial evidence for evaluating the safety of the vaccine in pregnancy for health professionals and the public and can help to inform vaccination policy making.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.