Details:

Alternative Title:
JAMA
Personal Author:
Kharbanda, Elyse O. ; Vazquez-Benitez, Gabriela ; Lipkind, Heather S. ; Klein, Nicola P. ; Cheetham, T.Craig ; ... More +
Kharbanda, Elyse O. ; Vazquez-Benitez, Gabriela ; Lipkind, Heather S. ; Klein, Nicola P. ; Cheetham, T.Craig ; Naleway, Allison ; Omer, Saad B. ; Hambidge, Simon J. ; Lee, Grace M. ; Jackson, Michael L. ; McCarthy, Natalie L. ; DeStefano, Frank ; Nordin, James D. Less -
Description:
IMPORTANCE

In 2010, due to a pertussis outbreak and neonatal deaths, the California Department of Health recommended that the tetanus toxoid, reduced diphtheria toxoid, and acellular pertussis vaccine (Tdap) be administered during pregnancy. Tdap is now recommended by the Advisory Committee on Immunization Practices for all pregnant women, preferably between 27 and 36 weeks’ gestation. Limited data exist on Tdap safety during pregnancy.

OBJECTIVE

To evaluate whether maternal Tdap vaccination during pregnancy is associated with increased risks of adverse obstetric events or adverse birth outcomes.

DESIGN AND SETTING

Retrospective, observational cohort study using administrative health care databases from 2 California Vaccine Safety Datalink sites.

PARTICIPANTS AND EXPOSURES

Of 123 494 women with singleton pregnancies ending in a live birth between January 1, 2010, and November 15, 2012, 26 229 (21%) received Tdap during pregnancy and 97 265 did not.

MAIN OUTCOMES AND MEASURES

Risks of small-for-gestational-age (SGA) births (<10th percentile), chorioamnionitis, preterm birth (<37 weeks’ gestation), and hypertensive disorders of pregnancy were evaluated. Relative risk (RR) estimates were adjusted for site, receipt of another vaccine during pregnancy, and propensity to receive Tdap during pregnancy. Cox regression was used for preterm delivery, and Poisson regression for other outcomes.

RESULTS

Vaccination was not associated with increased risks of adverse birth outcomes: crude estimates for preterm delivery were 6.3% of vaccinated and 7.8% of unvaccinated women (adjusted RR, 1.03; 95% CI, 0.97–1.09); 8.4% of vaccinated and 8.3% of unvaccinated had an SGA birth (adjusted RR, 1.00; 95% CI, 0.96–1.06). Receipt of Tdap before 20 weeks was not associated with hypertensive disorder of pregnancy (adjusted RR, 1.09; 95% CI, 0.99–1.20); chorioamnionitis was diagnosed in 6.1% of vaccinated and 5.5% of unvaccinated women (adjusted RR, 1.19; 95% CI, 1.13–1.26).

CONCLUSIONS AND RELEVANCE

In this cohort of women with singleton pregnancies that ended in live birth, receipt of Tdap during pregnancy was not associated with increased risk of hypertensive disorders of pregnancy or preterm or SGA birth, although a small but statistically significant increased risk of chorioamnionitis diagnosis was observed.


Subject:
[+]
Adolescent
Adult
Article
California
Chorioamnionitis
Cohort Studies
Diphtheria-Tetanus-acellular Pertussis Vaccines
Female
Humans
Hypertension, Pregnancy-Induced
Infant, Newborn
Infant, Small For Gestational Age
Pregnancy
Premature Birth
Retrospective Studies
Risk
Vaccination
Whooping Cough
Young Adult

Source:
JAMA. 312(18):1897-1904
Pubmed ID:
25387187
Pubmed Central ID:
PMC6599584
Document Type:
Journal Article
Funding:
CC999999/Intramural CDC HHS/United States ; 200-2012-53526/PHS HHS/United States ; 200-2012-53580/PHS HHS/United States ; 200-2012-53581/PHS HHS/United States
CC999999/Intramural CDC HHS/United States ; 200-2012-53526/PHS HHS/United States ; 200-2012-53580/PHS HHS/United States ; 200-2012-53581/PHS HHS/United States Less -
Collection(s):
CDC Public Access
Main Document Checksum:
[+]
urn:sha256:228d9c983914752166c85bbc9de448032ae12c2a20fe8f3bb884fb0be8bace33
File Type:

Supporting Files

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  	nihms-1023951-f0001.jpg	jpeg
  	nihms-1023951.nxml	xml
  	NIHMS1023951-supplement.pdf	pdf

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