Pregnancy Outcomes after a Mass Vaccination Campaign with an Oral Cholera Vaccine in Guinea: A Retrospective Cohort Study
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{"title"=>"Pregnancy Outcomes after a Mass Vaccination Campaign with an Oral Cholera Vaccine in Guinea: A Retrospective Cohort Study", "type"=>"journal", "authors"=>[{"first_name"=>"Lise", "last_name"=>"Grout", "scopus_author_id"=>"36094015500"}, {"first_name"=>"Isabel", "last_name"=>"Martinez-Pino", "scopus_author_id"=>"35237847300"}, {"first_name"=>"Iza", "last_name"=>"Ciglenecki", "scopus_author_id"=>"13906928800"}, {"first_name"=>"Sakoba", "last_name"=>"Keita", "scopus_author_id"=>"56237053700"}, {"first_name"=>"Alpha Amadou", "last_name"=>"Diallo", "scopus_author_id"=>"57196700750"}, {"first_name"=>"Balla", "last_name"=>"Traore", "scopus_author_id"=>"55921534600"}, {"first_name"=>"Daloka", "last_name"=>"Delamou", "scopus_author_id"=>"57039050700"}, {"first_name"=>"Oumar", "last_name"=>"Toure", "scopus_author_id"=>"57190873038"}, {"first_name"=>"Sarala", "last_name"=>"Nicholas", "scopus_author_id"=>"36904834700"}, {"first_name"=>"Barbara", "last_name"=>"Rusch", "scopus_author_id"=>"37031770200"}, {"first_name"=>"Nelly", "last_name"=>"Staderini", "scopus_author_id"=>"55364073300"}, {"first_name"=>"Micaela", "last_name"=>"Serafini", "scopus_author_id"=>"55922272800"}, {"first_name"=>"Rebecca F.", "last_name"=>"Grais", "scopus_author_id"=>"12801197700"}, {"first_name"=>"Francisco J.", "last_name"=>"Luquero", "scopus_author_id"=>"23479690100"}], "year"=>2015, "source"=>"PLoS Neglected Tropical Diseases", "identifiers"=>{"scopus"=>"2-s2.0-84953256081", "pmid"=>"26713614", "sgr"=>"84953256081", "doi"=>"10.1371/journal.pntd.0004274", "isbn"=>"1935-2727", "issn"=>"19352735", "pui"=>"607461900"}, "id"=>"e58b4fa6-0466-39f8-bc3b-30a819e824cf", "abstract"=>"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.", "link"=>"http://www.mendeley.com/research/pregnancy-outcomes-after-mass-vaccination-campaign-oral-cholera-vaccine-guinea-retrospective-cohort-5", "reader_count"=>19, "reader_count_by_academic_status"=>{"Researcher"=>4, "Student > Doctoral Student"=>1, "Student > Ph. D. Student"=>2, "Student > Postgraduate"=>1, "Student > Master"=>3, "Other"=>3, "Student > Bachelor"=>4, "Lecturer"=>1}, "reader_count_by_user_role"=>{"Researcher"=>4, "Student > Doctoral Student"=>1, "Student > Ph. D. Student"=>2, "Student > Postgraduate"=>1, "Student > Master"=>3, "Other"=>3, "Student > Bachelor"=>4, "Lecturer"=>1}, "reader_count_by_subject_area"=>{"Unspecified"=>2, "Biochemistry, Genetics and Molecular Biology"=>3, "Nursing and Health Professions"=>3, "Mathematics"=>1, "Medicine and Dentistry"=>8, "Design"=>1, "Social Sciences"=>1}, "reader_count_by_subdiscipline"=>{"Design"=>{"Design"=>1}, "Medicine and Dentistry"=>{"Medicine and Dentistry"=>8}, "Social Sciences"=>{"Social Sciences"=>1}, "Nursing and Health Professions"=>{"Nursing and Health Professions"=>3}, "Biochemistry, Genetics and Molecular Biology"=>{"Biochemistry, Genetics and Molecular Biology"=>3}, "Mathematics"=>{"Mathematics"=>1}, "Unspecified"=>{"Unspecified"=>2}}, "reader_count_by_country"=>{"United States"=>1}, "group_count"=>1}

Scopus | Further Information

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Figshare

  • {"files"=>["https://ndownloader.figshare.com/files/2618458"], "description"=>"<p>Timeline of the cholera vaccination campaign and field surveys in Boffa prefecture, Guinea, 2012 and 2013.</p>", "links"=>[], "tags"=>["ocv", "retrospective cohort study", "BivWC vaccine", "mass vaccination campaign", "FindingsFrom 11 November", "Oral Cholera Vaccine", "ci", "pregnancy loss", "binomial regression analysis", "cholera vaccination campaigns"], "article_id"=>1631426, "categories"=>["Biological Sciences"], "users"=>["Lise Grout", "Isabel Martinez-Pino", "Iza Ciglenecki", "Sakoba Keita", "Alpha Amadou Diallo", "Balla Traore", "Daloka Delamou", "Oumar Toure", "Sarala Nicholas", "Barbara Rusch", "Nelly Staderini", "Micaela Serafini", "Rebecca F. Grais", "Francisco J. Luquero"], "doi"=>"https://dx.doi.org/10.1371/journal.pntd.0004274.g001", "stats"=>{"downloads"=>0, "page_views"=>1, "likes"=>0}, "figshare_url"=>"https://figshare.com/articles/_Timeline_of_the_cholera_vaccination_campaign_and_field_surveys_in_Boffa_prefecture_Guinea_2012_and_2013_/1631426", "title"=>"Timeline of the cholera vaccination campaign and field surveys in Boffa prefecture, Guinea, 2012 and 2013.", "pos_in_sequence"=>0, "defined_type"=>1, "published_date"=>"2016-01-05 14:55:14"}
  • {"files"=>["https://ndownloader.figshare.com/files/2618459"], "description"=>"<p>Enrollment of study participants for the primary analysis and the bias-indicator analysis, Boffa prefecture, Guinea, 2013.</p>", "links"=>[], "tags"=>["ocv", "retrospective cohort study", "BivWC vaccine", "mass vaccination campaign", "FindingsFrom 11 November", "Oral Cholera Vaccine", "ci", "pregnancy loss", "binomial regression analysis", "cholera vaccination campaigns"], "article_id"=>1631427, "categories"=>["Biological Sciences"], "users"=>["Lise Grout", "Isabel Martinez-Pino", "Iza Ciglenecki", "Sakoba Keita", "Alpha Amadou Diallo", "Balla Traore", "Daloka Delamou", "Oumar Toure", "Sarala Nicholas", "Barbara Rusch", "Nelly Staderini", "Micaela Serafini", "Rebecca F. Grais", "Francisco J. Luquero"], "doi"=>"https://dx.doi.org/10.1371/journal.pntd.0004274.g002", "stats"=>{"downloads"=>0, "page_views"=>1, "likes"=>0}, "figshare_url"=>"https://figshare.com/articles/_Enrollment_of_study_participants_for_the_primary_analysis_and_the_bias_indicator_analysis_Boffa_prefecture_Guinea_2013_/1631427", "title"=>"Enrollment of study participants for the primary analysis and the bias-indicator analysis, Boffa prefecture, Guinea, 2013.", "pos_in_sequence"=>0, "defined_type"=>1, "published_date"=>"2016-01-05 14:55:12"}
  • {"files"=>["https://ndownloader.figshare.com/files/2618460", "https://ndownloader.figshare.com/files/2618461"], "description"=>"<div><p>Introduction</p><p>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.</p><p>Methods and Findings</p><p>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).</p><p>Conclusions</p><p>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.</p></div>", "links"=>[], "tags"=>["ocv", "retrospective cohort study", "BivWC vaccine", "mass vaccination campaign", "FindingsFrom 11 November", "Oral Cholera Vaccine", "ci", "pregnancy loss", "binomial regression analysis", "cholera vaccination campaigns"], "article_id"=>1631428, "categories"=>["Biological Sciences"], "users"=>["Lise Grout", "Isabel Martinez-Pino", "Iza Ciglenecki", "Sakoba Keita", "Alpha Amadou Diallo", "Balla Traore", "Daloka Delamou", "Oumar Toure", "Sarala Nicholas", "Barbara Rusch", "Nelly Staderini", "Micaela Serafini", "Rebecca F. Grais", "Francisco J. Luquero"], "doi"=>["https://dx.doi.org/10.1371/journal.pntd.0004274.s001", "https://dx.doi.org/10.1371/journal.pntd.0004274.s002"], "stats"=>{"downloads"=>1, "page_views"=>2, "likes"=>0}, "figshare_url"=>"https://figshare.com/articles/_Pregnancy_Outcomes_after_a_Mass_Vaccination_Campaign_with_an_Oral_Cholera_Vaccine_in_Guinea_A_Retrospective_Cohort_Study_/1631428", "title"=>"Pregnancy Outcomes after a Mass Vaccination Campaign with an Oral Cholera Vaccine in Guinea: A Retrospective Cohort Study", "pos_in_sequence"=>0, "defined_type"=>4, "published_date"=>"2016-01-05 14:55:12"}

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Relative Metric

{"start_date"=>"2015-01-01T00:00:00Z", "end_date"=>"2015-12-31T00:00:00Z", "subject_areas"=>[]}
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