Risks associated with smallpox vaccination in pregnancy

A systematic review and meta-analysis

Martina L. Badell, Dana Meaney-Delman, Methodius G. Tuuli, Sonja A. Rasmussen, Brett W. Petersen, Jeanne Sheffield, Richard H. Beigi, Inger K. Damon, Denise J. Jamieson

Research output: Contribution to journalReview article

Abstract

Objective: To estimate the maternal and fetal risks of smallpox vaccination during pregnancy. DATA SOURCES: MEDLINE, Web of Science, EMBASE, Global Health, ClinicalTrials.gov, and CINHAL from inception to September 2014. METHODS OF STUDY SELECTION: We included published articles containing primary data regarding smallpox vaccination during pregnancy that reported maternal or fetal outcomes (spontaneous abortion, congenital defect, stillbirth, preterm birth, or fetal vaccinia). TABULATIONS, INTEGRATION, AND Results: The primary search yielded 887 articles. After hand-searching, 37 articles were included: 18 articles with fetal outcome data and 19 case reports of fetal vaccinia. Outcomes of smallpox vaccination in 12,201 pregnant women were included. Smallpox vaccination was not associated with an increased risk of spontaneous abortion (pooled relative risk [RR] 1.03, confidence interval [CI] 0.76-1.41), stillbirth (pooled RR 1.03, CI 0.75-1.40), or preterm birth (pooled RR 0.84, CI 0.62-1.15). When vaccination in any trimester was considered, smallpox vaccination was not associated with an increased risk of congenital defects (pooled RR 1.25, CI 0.99-1.56); however, first-trimester exposure was associated with an increased risk of congenital defects (2.4% compared with 1.5%, pooled RR 1.34, CI 1.02-1.77). No cases of fetal vaccinia were reported in the studies examining fetal outcomes; 21 cases of fetal vaccinia were identified in the literature, of which three neonates survived. Conclusion: The overall risk associated with maternal smallpox vaccination appears low. No association between smallpox vaccination and spontaneous abortion, preterm birth, or stillbirth was identified. First-trimester vaccination was associated with a small increase in congenital defects, but the effect size was small and based on limited data. Fetal vaccinia appears to be a rare consequence of maternal smallpox vaccination but is associated with a high rate of fetal loss.

Original languageEnglish (US)
Pages (from-to)1439-1451
Number of pages13
JournalObstetrics and Gynecology
Volume125
Issue number6
DOIs
StatePublished - Jun 28 2015
Externally publishedYes

Fingerprint

Smallpox
Meta-Analysis
Vaccination
Vaccinia
Pregnancy
Stillbirth
Confidence Intervals
Premature Birth
Spontaneous Abortion
Mothers
First Pregnancy Trimester
MEDLINE
Pregnant Women
Newborn Infant

ASJC Scopus subject areas

  • Obstetrics and Gynecology
  • Medicine(all)

Cite this

Badell, M. L., Meaney-Delman, D., Tuuli, M. G., Rasmussen, S. A., Petersen, B. W., Sheffield, J., ... Jamieson, D. J. (2015). Risks associated with smallpox vaccination in pregnancy: A systematic review and meta-analysis. Obstetrics and Gynecology, 125(6), 1439-1451. https://doi.org/10.1097/AOG.0000000000000857

Risks associated with smallpox vaccination in pregnancy : A systematic review and meta-analysis. / Badell, Martina L.; Meaney-Delman, Dana; Tuuli, Methodius G.; Rasmussen, Sonja A.; Petersen, Brett W.; Sheffield, Jeanne; Beigi, Richard H.; Damon, Inger K.; Jamieson, Denise J.

In: Obstetrics and Gynecology, Vol. 125, No. 6, 28.06.2015, p. 1439-1451.

Research output: Contribution to journalReview article

Badell, ML, Meaney-Delman, D, Tuuli, MG, Rasmussen, SA, Petersen, BW, Sheffield, J, Beigi, RH, Damon, IK & Jamieson, DJ 2015, 'Risks associated with smallpox vaccination in pregnancy: A systematic review and meta-analysis', Obstetrics and Gynecology, vol. 125, no. 6, pp. 1439-1451. https://doi.org/10.1097/AOG.0000000000000857
Badell, Martina L. ; Meaney-Delman, Dana ; Tuuli, Methodius G. ; Rasmussen, Sonja A. ; Petersen, Brett W. ; Sheffield, Jeanne ; Beigi, Richard H. ; Damon, Inger K. ; Jamieson, Denise J. / Risks associated with smallpox vaccination in pregnancy : A systematic review and meta-analysis. In: Obstetrics and Gynecology. 2015 ; Vol. 125, No. 6. pp. 1439-1451.
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abstract = "Objective: To estimate the maternal and fetal risks of smallpox vaccination during pregnancy. DATA SOURCES: MEDLINE, Web of Science, EMBASE, Global Health, ClinicalTrials.gov, and CINHAL from inception to September 2014. METHODS OF STUDY SELECTION: We included published articles containing primary data regarding smallpox vaccination during pregnancy that reported maternal or fetal outcomes (spontaneous abortion, congenital defect, stillbirth, preterm birth, or fetal vaccinia). TABULATIONS, INTEGRATION, AND Results: The primary search yielded 887 articles. After hand-searching, 37 articles were included: 18 articles with fetal outcome data and 19 case reports of fetal vaccinia. Outcomes of smallpox vaccination in 12,201 pregnant women were included. Smallpox vaccination was not associated with an increased risk of spontaneous abortion (pooled relative risk [RR] 1.03, confidence interval [CI] 0.76-1.41), stillbirth (pooled RR 1.03, CI 0.75-1.40), or preterm birth (pooled RR 0.84, CI 0.62-1.15). When vaccination in any trimester was considered, smallpox vaccination was not associated with an increased risk of congenital defects (pooled RR 1.25, CI 0.99-1.56); however, first-trimester exposure was associated with an increased risk of congenital defects (2.4{\%} compared with 1.5{\%}, pooled RR 1.34, CI 1.02-1.77). No cases of fetal vaccinia were reported in the studies examining fetal outcomes; 21 cases of fetal vaccinia were identified in the literature, of which three neonates survived. Conclusion: The overall risk associated with maternal smallpox vaccination appears low. No association between smallpox vaccination and spontaneous abortion, preterm birth, or stillbirth was identified. First-trimester vaccination was associated with a small increase in congenital defects, but the effect size was small and based on limited data. Fetal vaccinia appears to be a rare consequence of maternal smallpox vaccination but is associated with a high rate of fetal loss.",
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T1 - Risks associated with smallpox vaccination in pregnancy

T2 - A systematic review and meta-analysis

AU - Badell, Martina L.

AU - Meaney-Delman, Dana

AU - Tuuli, Methodius G.

AU - Rasmussen, Sonja A.

AU - Petersen, Brett W.

AU - Sheffield, Jeanne

AU - Beigi, Richard H.

AU - Damon, Inger K.

AU - Jamieson, Denise J.

PY - 2015/6/28

Y1 - 2015/6/28

N2 - Objective: To estimate the maternal and fetal risks of smallpox vaccination during pregnancy. DATA SOURCES: MEDLINE, Web of Science, EMBASE, Global Health, ClinicalTrials.gov, and CINHAL from inception to September 2014. METHODS OF STUDY SELECTION: We included published articles containing primary data regarding smallpox vaccination during pregnancy that reported maternal or fetal outcomes (spontaneous abortion, congenital defect, stillbirth, preterm birth, or fetal vaccinia). TABULATIONS, INTEGRATION, AND Results: The primary search yielded 887 articles. After hand-searching, 37 articles were included: 18 articles with fetal outcome data and 19 case reports of fetal vaccinia. Outcomes of smallpox vaccination in 12,201 pregnant women were included. Smallpox vaccination was not associated with an increased risk of spontaneous abortion (pooled relative risk [RR] 1.03, confidence interval [CI] 0.76-1.41), stillbirth (pooled RR 1.03, CI 0.75-1.40), or preterm birth (pooled RR 0.84, CI 0.62-1.15). When vaccination in any trimester was considered, smallpox vaccination was not associated with an increased risk of congenital defects (pooled RR 1.25, CI 0.99-1.56); however, first-trimester exposure was associated with an increased risk of congenital defects (2.4% compared with 1.5%, pooled RR 1.34, CI 1.02-1.77). No cases of fetal vaccinia were reported in the studies examining fetal outcomes; 21 cases of fetal vaccinia were identified in the literature, of which three neonates survived. Conclusion: The overall risk associated with maternal smallpox vaccination appears low. No association between smallpox vaccination and spontaneous abortion, preterm birth, or stillbirth was identified. First-trimester vaccination was associated with a small increase in congenital defects, but the effect size was small and based on limited data. Fetal vaccinia appears to be a rare consequence of maternal smallpox vaccination but is associated with a high rate of fetal loss.

AB - Objective: To estimate the maternal and fetal risks of smallpox vaccination during pregnancy. DATA SOURCES: MEDLINE, Web of Science, EMBASE, Global Health, ClinicalTrials.gov, and CINHAL from inception to September 2014. METHODS OF STUDY SELECTION: We included published articles containing primary data regarding smallpox vaccination during pregnancy that reported maternal or fetal outcomes (spontaneous abortion, congenital defect, stillbirth, preterm birth, or fetal vaccinia). TABULATIONS, INTEGRATION, AND Results: The primary search yielded 887 articles. After hand-searching, 37 articles were included: 18 articles with fetal outcome data and 19 case reports of fetal vaccinia. Outcomes of smallpox vaccination in 12,201 pregnant women were included. Smallpox vaccination was not associated with an increased risk of spontaneous abortion (pooled relative risk [RR] 1.03, confidence interval [CI] 0.76-1.41), stillbirth (pooled RR 1.03, CI 0.75-1.40), or preterm birth (pooled RR 0.84, CI 0.62-1.15). When vaccination in any trimester was considered, smallpox vaccination was not associated with an increased risk of congenital defects (pooled RR 1.25, CI 0.99-1.56); however, first-trimester exposure was associated with an increased risk of congenital defects (2.4% compared with 1.5%, pooled RR 1.34, CI 1.02-1.77). No cases of fetal vaccinia were reported in the studies examining fetal outcomes; 21 cases of fetal vaccinia were identified in the literature, of which three neonates survived. Conclusion: The overall risk associated with maternal smallpox vaccination appears low. No association between smallpox vaccination and spontaneous abortion, preterm birth, or stillbirth was identified. First-trimester vaccination was associated with a small increase in congenital defects, but the effect size was small and based on limited data. Fetal vaccinia appears to be a rare consequence of maternal smallpox vaccination but is associated with a high rate of fetal loss.

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