Evidence map›Paper›PMID 37117057›Full record

Observational studyVaccine2023

Tdap vaccination during pregnancy and risk of chorioamnionitis and related infant outcomes.

Victoria Greenberg, Gabriela Vazquez-Benitez, Elyse O Kharbanda, Matthew F Daley, Hung Fu Tseng, Nicola P Klein, Allison L Naleway, Joshua T B Williams, James Donahue, Lisa Jackson and 3 more

Open access · hybridAbstract readObservational Study
In one paragraph

Observational study in Vaccine, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 6 papers.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed
2.4field-weighted citation impact, top 11% of its field
1 · What the graph read from 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.

2 · The registry

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.

3 · Its place in the literature

Who cites it

6 citing papers in PubMed, 11 citations in OpenAlex.

  1. Review
  2. Article
  3. Article
  4. Review
  5. Review
  6. Safety and Clinical Benefits of AdacelInfectious diseases and therapy · 2023
    Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

13 authors at 8 institutions in 1 country.

Victoria GreenbergMedStar Washington Hospital Center, Washington, DC, United States. Electronic address: victoria.r.greenberg@medstar.net.
Gabriela Vazquez-BenitezHealthPartners Institute, Bloomington, MN, United States.
Elyse O KharbandaHealthPartners Institute, Bloomington, MN, United States.
Matthew F DaleyInstitute for Health Research, Kaiser Permanente Colorado, Denver, CO, United States.
Hung Fu TsengKaiser Permanente Southern California, Pasadena, CA, United States.
Nicola P KleinKaiser Permanente Vaccine Study Center, Oakland, CA, United States.
Allison L NalewayCenter for Health Research, Kaiser Permanente Northwest, Portland, OR, United States.
Joshua T B WilliamsAmbulatory Care Services, Denver Health, Denver, CO, United States.
James DonahueMarshfield Clinic, Research Institute, Marshfield, WI, United States.
Lisa JacksonKaiser Permanente Washington, Seattle, WA, United States.
Eric WeintraubImmunization Safety Office, U.S. Centers for Disease Control and Prevention, Atlanta, GA, United States.
Heather LipkindWeill Cornell Medicine, New York, NY, United States.
Malini B DeSilvaHealthPartners Institute, Bloomington, MN, United States.
Kaiser Permanente · USHealthPartners · USCenters for Disease Control and Prevention · USCornell University · USDenver Health Medical Center · USKaiser Permanente Center for Health Research · USMarshfield Clinic · USMedStar Washington Hospital Center · US

Funding

Intramural CDC HHS CC999999
6 · The paper itself

Abstract

introductionAn increased risk of chorioamnionitis in people receiving tetanus toxoid, reduced diphtheria toxoid, and acellular pertussis (Tdap) vaccine during pregnancy has been reported. The importance of this association is unclear as additional study has not demonstrated increased adverse infant outcomes associated with Tdap vaccination in pregnancy.

methodsWe conducted a retrospective observational cohort study of pregnant people ages 15-49 years with singleton pregnancies ending in live birth who were members of 8 Vaccine Safety Datalink (VSD) sites during October 2016-September 2018. We used a time-dependent covariate Cox model with stabilized inverse probability weights applied to evaluate associations between Tdap vaccination during pregnancy and chorioamnionitis and preterm birth outcomes. We used Poisson regression with robust variance with stabilized inverse probability weights applied to evaluate the association of Tdap vaccination with adverse infant outcomes. We performed medical record reviews on a random sample of patients with ICD-10-CM-diagnosed chorioamnionitis to determine positive predictive values (PPV) of coded chorioamnionitisfor "probable clinical chorioamnionitis," "possible clinical chorioamnionitis," or "histologic chorioamnionitis."

resultsWe included 118,211 pregnant people; 103,258 (87%) received Tdap vaccine during pregnancy; 8098 (7%) were diagnosed with chorioamnionitis. The adjusted hazard ratio for chorioamnionitis in the Tdap vaccine-exposed group compared to unexposed was 0.96 (95% CI 0.90-1.03). There was no association between Tdap vaccine and preterm birth or adverse infant outcomes associated with chorioamnionitis. Chart reviews were performed for 528 pregnant people with chorioamnionitis. The PPV for clinical (probable or possible clinical chorioamnionitis) was 48% and 59% for histologic chorioamnionitis. The PPV for the combined outcome of clinical or histologic chorioamnionitis was 81%. CONCLUSIONS AND RELEVANCE: Tdap vaccine exposure during pregnancy was not associated with chorioamnionitis, preterm birth, or adverse infant outcomes. ICD-10 codes for chorioamnionitis lack specificity for clinical chorioamnionitis and should be a recognized limitation when interpreting results.

Indexed as

ChorioamnionitisDiphtheria-Tetanus-acellular Pertussis VaccinesPremature BirthTetanusWhooping CoughFemaleHumansInfantInfant, NewbornRetrospective StudiesToxoidsVaccinationDiphtheria-Tetanus-acellular Pertussis VaccinesToxoidsChorioamnionitisInfantPregnancyVaccination

Identifiers

PMID37117057
PMCPMC10466272
OpenAlexW4367042676

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

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.