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Pregnancy Outcomes after a Mass Vaccination Campaign with an Oral Cholera Vaccine in Guinea: A Retrospective Cohort Study

INTRODUCTION: Since 2010, WHO has recommended oral cholera vaccines as an additional strategy for cholera control. During a cholera episode, pregnant women are at high risk of complications, and the risk of fetal death has been reported to be 2–36%. Due to a lack of safety data, pregnant women have...

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Autores principales: Grout, Lise, Martinez-Pino, Isabel, Ciglenecki, Iza, Keita, Sakoba, Diallo, Alpha Amadou, Traore, Balla, Delamou, Daloka, Toure, Oumar, Nicholas, Sarala, Rusch, Barbara, Staderini, Nelly, Serafini, Micaela, Grais, Rebecca F., Luquero, Francisco J.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Public Library of Science 2015
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4695076/
https://www.ncbi.nlm.nih.gov/pubmed/26713614
http://dx.doi.org/10.1371/journal.pntd.0004274
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author Grout, Lise
Martinez-Pino, Isabel
Ciglenecki, Iza
Keita, Sakoba
Diallo, Alpha Amadou
Traore, Balla
Delamou, Daloka
Toure, Oumar
Nicholas, Sarala
Rusch, Barbara
Staderini, Nelly
Serafini, Micaela
Grais, Rebecca F.
Luquero, Francisco J.
author_facet Grout, Lise
Martinez-Pino, Isabel
Ciglenecki, Iza
Keita, Sakoba
Diallo, Alpha Amadou
Traore, Balla
Delamou, Daloka
Toure, Oumar
Nicholas, Sarala
Rusch, Barbara
Staderini, Nelly
Serafini, Micaela
Grais, Rebecca F.
Luquero, Francisco J.
author_sort Grout, Lise
collection PubMed
description INTRODUCTION: Since 2010, WHO has recommended oral cholera vaccines as an additional strategy for cholera control. During a cholera episode, pregnant women are at high risk of complications, and the risk of fetal death has been reported to be 2–36%. Due to a lack of safety data, pregnant women have been excluded from most cholera vaccination campaigns. In 2012, reactive campaigns using the bivalent killed whole-cell oral cholera vaccine (BivWC), included all people living in the targeted areas aged ≥1 year regardless of pregnancy status, were implemented in Guinea. We aimed to determine whether there was a difference in pregnancy outcomes between vaccinated and non-vaccinated pregnant women. METHODS AND FINDINGS: From 11 November to 4 December 2013, we conducted a retrospective cohort study in Boffa prefecture among women who were pregnant in 2012 during or after the vaccination campaign. The primary outcome was pregnancy loss, as reported by the mother, and fetal malformations, after clinical examination. Primary exposure was the intake of the BivWC vaccine (Shanchol) during pregnancy, as determined by a vaccination card or oral history. We compared the risk of pregnancy loss between vaccinated and non-vaccinated women through binomial regression analysis. A total of 2,494 pregnancies were included in the analysis. The crude incidence of pregnancy loss was 3.7% (95%CI 2.7–4.8) for fetuses exposed to BivWC vaccine and 2.6% (0.7–4.5) for non-exposed fetuses. The incidence of malformation was 0.6% (0.1–1.0) and 1.2% (0.0–2.5) in BivWC-exposed and non-exposed fetuses, respectively. In both crude and adjusted analyses, fetal exposure to BivWC was not significantly associated with pregnancy loss (adjusted risk ratio (aRR = 1.09 [95%CI: 0.5–2.25], p = 0.818) or malformations (aRR = 0.50 [95%CI: 0.13–1.91], p = 0.314). CONCLUSIONS: In this large retrospective cohort study, we found no association between fetal exposure to BivWC and risk of pregnancy loss or malformation. Despite the weaknesses of a retrospective design, we can conclude that if a risk exists, it is very low. Additional prospective studies are warranted to add to the evidence base on OCV use during pregnancy. Pregnant women are particularly vulnerable during cholera episodes and should be included in vaccination campaigns when the risk of cholera is high, such as during outbreaks.
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spelling pubmed-46950762016-01-13 Pregnancy Outcomes after a Mass Vaccination Campaign with an Oral Cholera Vaccine in Guinea: A Retrospective Cohort Study Grout, Lise Martinez-Pino, Isabel Ciglenecki, Iza Keita, Sakoba Diallo, Alpha Amadou Traore, Balla Delamou, Daloka Toure, Oumar Nicholas, Sarala Rusch, Barbara Staderini, Nelly Serafini, Micaela Grais, Rebecca F. Luquero, Francisco J. PLoS Negl Trop Dis Research Article INTRODUCTION: Since 2010, WHO has recommended oral cholera vaccines as an additional strategy for cholera control. During a cholera episode, pregnant women are at high risk of complications, and the risk of fetal death has been reported to be 2–36%. Due to a lack of safety data, pregnant women have been excluded from most cholera vaccination campaigns. In 2012, reactive campaigns using the bivalent killed whole-cell oral cholera vaccine (BivWC), included all people living in the targeted areas aged ≥1 year regardless of pregnancy status, were implemented in Guinea. We aimed to determine whether there was a difference in pregnancy outcomes between vaccinated and non-vaccinated pregnant women. METHODS AND FINDINGS: From 11 November to 4 December 2013, we conducted a retrospective cohort study in Boffa prefecture among women who were pregnant in 2012 during or after the vaccination campaign. The primary outcome was pregnancy loss, as reported by the mother, and fetal malformations, after clinical examination. Primary exposure was the intake of the BivWC vaccine (Shanchol) during pregnancy, as determined by a vaccination card or oral history. We compared the risk of pregnancy loss between vaccinated and non-vaccinated women through binomial regression analysis. A total of 2,494 pregnancies were included in the analysis. The crude incidence of pregnancy loss was 3.7% (95%CI 2.7–4.8) for fetuses exposed to BivWC vaccine and 2.6% (0.7–4.5) for non-exposed fetuses. The incidence of malformation was 0.6% (0.1–1.0) and 1.2% (0.0–2.5) in BivWC-exposed and non-exposed fetuses, respectively. In both crude and adjusted analyses, fetal exposure to BivWC was not significantly associated with pregnancy loss (adjusted risk ratio (aRR = 1.09 [95%CI: 0.5–2.25], p = 0.818) or malformations (aRR = 0.50 [95%CI: 0.13–1.91], p = 0.314). CONCLUSIONS: In this large retrospective cohort study, we found no association between fetal exposure to BivWC and risk of pregnancy loss or malformation. Despite the weaknesses of a retrospective design, we can conclude that if a risk exists, it is very low. Additional prospective studies are warranted to add to the evidence base on OCV use during pregnancy. Pregnant women are particularly vulnerable during cholera episodes and should be included in vaccination campaigns when the risk of cholera is high, such as during outbreaks. Public Library of Science 2015-12-29 /pmc/articles/PMC4695076/ /pubmed/26713614 http://dx.doi.org/10.1371/journal.pntd.0004274 Text en © 2015 Grout et al http://creativecommons.org/licenses/by/4.0/ This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are properly credited.
spellingShingle Research Article
Grout, Lise
Martinez-Pino, Isabel
Ciglenecki, Iza
Keita, Sakoba
Diallo, Alpha Amadou
Traore, Balla
Delamou, Daloka
Toure, Oumar
Nicholas, Sarala
Rusch, Barbara
Staderini, Nelly
Serafini, Micaela
Grais, Rebecca F.
Luquero, Francisco J.
Pregnancy Outcomes after a Mass Vaccination Campaign with an Oral Cholera Vaccine in Guinea: A Retrospective Cohort Study
title Pregnancy Outcomes after a Mass Vaccination Campaign with an Oral Cholera Vaccine in Guinea: A Retrospective Cohort Study
title_full Pregnancy Outcomes after a Mass Vaccination Campaign with an Oral Cholera Vaccine in Guinea: A Retrospective Cohort Study
title_fullStr Pregnancy Outcomes after a Mass Vaccination Campaign with an Oral Cholera Vaccine in Guinea: A Retrospective Cohort Study
title_full_unstemmed Pregnancy Outcomes after a Mass Vaccination Campaign with an Oral Cholera Vaccine in Guinea: A Retrospective Cohort Study
title_short Pregnancy Outcomes after a Mass Vaccination Campaign with an Oral Cholera Vaccine in Guinea: A Retrospective Cohort Study
title_sort pregnancy outcomes after a mass vaccination campaign with an oral cholera vaccine in guinea: a retrospective cohort study
topic Research Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4695076/
https://www.ncbi.nlm.nih.gov/pubmed/26713614
http://dx.doi.org/10.1371/journal.pntd.0004274
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