Stillbirth: Case definition and guidelines for data collection, analysis, and presentation of maternal immunization safety data☆
Identifieur interne : 000597 ( Pmc/Checkpoint ); précédent : 000596; suivant : 000598Stillbirth: Case definition and guidelines for data collection, analysis, and presentation of maternal immunization safety data☆
Auteurs : Fernanda Tavares Da Silva [Belgique] ; Bernard Gonik [États-Unis] ; Mark Mcmillan [Australie] ; Cheryl Keech [États-Unis] ; Stephanie Dellicour [Royaume-Uni] ; Shraddha Bhange [Inde] ; Mihaela Tila [France] ; Diana M. Harper [États-Unis] ; Charles Woods [États-Unis] ; Alison Tse Kawai [États-Unis] ; Sonali Kochhar [Inde] ; Flor M. Munoz [États-Unis]Source :
- Vaccine [ 0264-410X ] ; 2016.
Url:
DOI: 10.1016/j.vaccine.2016.03.044
PubMed: 27431422
PubMed Central: 5139804
Affiliations:
- Australie, Belgique, France, Inde, Royaume-Uni, États-Unis
- Auvergne-Rhône-Alpes, Kentucky, Massachusetts, Michigan, Rhône-Alpes, Texas, Washington (État)
- Lyon
Links toward previous steps (curation, corpus...)
Links to Exploration step
PMC:5139804Le document en format XML
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<front><journal-meta><journal-id journal-id-type="nlm-ta">Vaccine</journal-id><journal-id journal-id-type="iso-abbrev">Vaccine</journal-id><journal-title-group><journal-title>Vaccine</journal-title></journal-title-group><issn pub-type="ppub">0264-410X</issn><issn pub-type="epub">1873-2518</issn><publisher><publisher-name>Elsevier Science</publisher-name></publisher></journal-meta><article-meta><article-id pub-id-type="pmid">27431422</article-id><article-id pub-id-type="pmc">5139804</article-id><article-id pub-id-type="publisher-id">S0264-410X(16)30027-5</article-id><article-id pub-id-type="doi">10.1016/j.vaccine.2016.03.044</article-id><article-categories><subj-group subj-group-type="heading"><subject>Article</subject></subj-group></article-categories><title-group><article-title>Stillbirth: Case definition and guidelines for data collection, analysis, and presentation of maternal immunization safety data<sup><xref ref-type="fn" rid="d32e165">☆</xref></sup></article-title></title-group><contrib-group><contrib contrib-type="author"><name><surname>Da Silva</surname><given-names>Fernanda Tavares</given-names></name><xref rid="aff0005" ref-type="aff">a</xref></contrib><contrib contrib-type="author"><name><surname>Gonik</surname><given-names>Bernard</given-names></name><xref rid="aff0010" ref-type="aff">b</xref></contrib><contrib contrib-type="author"><name><surname>McMillan</surname><given-names>Mark</given-names></name><xref rid="aff0015" ref-type="aff">c</xref></contrib><contrib contrib-type="author"><name><surname>Keech</surname><given-names>Cheryl</given-names></name><xref rid="aff0020" ref-type="aff">d</xref></contrib><contrib contrib-type="author"><name><surname>Dellicour</surname><given-names>Stephanie</given-names></name><xref rid="aff0025" ref-type="aff">e</xref></contrib><contrib contrib-type="author"><name><surname>Bhange</surname><given-names>Shraddha</given-names></name><xref rid="aff0030" ref-type="aff">f</xref></contrib><contrib contrib-type="author"><name><surname>Tila</surname><given-names>Mihaela</given-names></name><xref rid="aff0035" ref-type="aff">g</xref></contrib><contrib contrib-type="author"><name><surname>Harper</surname><given-names>Diana M.</given-names></name><xref rid="aff0040" ref-type="aff">h</xref></contrib><contrib contrib-type="author"><name><surname>Woods</surname><given-names>Charles</given-names></name><xref rid="aff0040" ref-type="aff">h</xref></contrib><contrib contrib-type="author"><name><surname>Kawai</surname><given-names>Alison Tse</given-names></name><xref rid="aff0045" ref-type="aff">i</xref></contrib><contrib contrib-type="author"><name><surname>Kochhar</surname><given-names>Sonali</given-names></name><xref rid="aff0050" ref-type="aff">j</xref></contrib><contrib contrib-type="author"><name><surname>Munoz</surname><given-names>Flor M.</given-names></name><email>contact@brightoncollaboration.org</email><email>secretariat@brightoncollaboration.org</email><xref rid="aff0055" ref-type="aff">k</xref><xref rid="cor0005" ref-type="corresp">⁎</xref></contrib><contrib contrib-type="author"><collab>The Brighton Collaboration Stillbirth Working Group</collab><xref rid="fn0075" ref-type="fn">1</xref></contrib></contrib-group><aff id="aff0005"><label>a</label>GlaxoSmithKline Biologicals, Wavre, Belgium</aff><aff id="aff0010"><label>b</label>Wayne State University School of Medicine, Detroit, MI, USA</aff><aff id="aff0015"><label>c</label>The University of Adelaide, North Adelaide, South Australia, Australia</aff><aff id="aff0020"><label>d</label>PATH, Seattle, WA, USA</aff><aff id="aff0025"><label>e</label>Liverpool School of Tropical Medicine, Liverpool, United Kingdom</aff><aff id="aff0030"><label>f</label>Novartis Healthcare, Hyderabad, India</aff><aff id="aff0035"><label>g</label>Sanofi Pasteur, Lyon, France</aff><aff id="aff0040"><label>h</label>University of Louisville School of Medicine, Louisville, KY, USA</aff><aff id="aff0045"><label>i</label>Harvard Medical School and Harvard Pilgrim Health Care Institute, MA, USA</aff><aff id="aff0050"><label>j</label>Global Healthcare Consulting, India</aff><aff id="aff0055"><label>k</label>Baylor College of Medicine, Houston, TX, USA</aff><author-notes><corresp id="cor0005"><label>⁎</label>Corresponding author. Tel.: +1 713 798 5248/832 824 4371. <email>contact@brightoncollaboration.org</email><email>secretariat@brightoncollaboration.org</email></corresp><fn id="fn0075"><label>1</label><p id="npar0010">Brighton Collaboration home page: <ext-link ext-link-type="uri" xlink:href="http://www.brightoncollaboration.org/" id="intr0005">http://www.brightoncollaboration.org</ext-link>.</p></fn></author-notes><pub-date pub-type="pmc-release"><day>01</day><month>12</month><year>2016</year></pub-date><pmc-comment> PMC Release delay is 0 months and 0 days and was based on .</pmc-comment>
<pub-date pub-type="ppub"><day>01</day><month>12</month><year>2016</year></pub-date><volume>34</volume><issue>49</issue><fpage>6057</fpage><lpage>6068</lpage><permissions><copyright-statement>© 2016 Published by Elsevier Ltd.</copyright-statement><copyright-year>2016</copyright-year><copyright-holder></copyright-holder><license license-type="CC BY" xlink:href="http://creativecommons.org/licenses/by/4.0/"><license-p>This is an open access article under the CC BY license (http://creativecommons.org/licenses/by/4.0/).</license-p></license></permissions><kwd-group id="kwd0005"><title>Keywords</title><kwd>Stillbirth</kwd><kwd>Fetal death</kwd><kwd>Adverse event</kwd><kwd>Immunization</kwd><kwd>Guidelines</kwd><kwd>Case definition</kwd></kwd-group></article-meta></front><floats-group><table-wrap id="tbl0010" position="float"><label>Table 1</label><caption><p>Existing conventional definitions for Stillbirth.</p></caption><alt-text id="at1">Table 1</alt-text><table frame="hsides" rules="groups"><thead><tr><th align="left">Source</th><th align="left">Gestational Age (weeks)</th><th align="left">Birth weight (g)</th><th align="left">Height criteria (crown-heel length)</th><th align="left">Definition</th></tr></thead><tbody><tr><td align="left">USA (CDC)</td><td align="left">≥20 0/7</td><td align="char">≥350</td><td></td><td align="left">The US federal guidelines recommend reporting those fetal deaths whose birth weight is of 350 g or more, or if weight is unknown, of 20 completed weeks gestation or more, calculated from the date last normal menstrual period; the death shall be reported within 5 days after delivery to the Office of Vital Statistics or as otherwise directed by the State Registrar. Forty-one areas use a definition very similar to the federal definition, thirteen areas use a shortened definition of fetal death, and three areas have no formal definition of fetal death. Only 11 areas specifically use the term ‘stillbirth’, often synonymously with late fetal death; however they are split between whether stillbirths are irrespective of the duration of pregnancy, and whether some age or weight constraint is applied <xref rid="bib1015" ref-type="bibr">[92]</xref>.</td></tr><tr><td align="left">WHO/ICD (use for general statistics and registration)</td><td align="left">≥22 0/7</td><td align="char">≥500</td><td align="char">≥25</td><td align="left">The International Classification of Diseases, 10th revision (ICD-10) defines a fetal death as: “<italic>death prior to the complete expulsion or extraction from its mother of a product of conception, irrespective of the duration of pregnancy; the death is indicated by the fact that after such separation the fetus does not breathe or show any other evidence of life, such as beating of the heart, pulsation of the umbilical cord, or definite movement of voluntary muscles without specification of the duration of pregnancy</italic>”. WHO/ICD defines stillbirths as the death of a fetus that has reached a birth weight of 500 g, or if birth weight is unavailable, gestational age of 22 weeks or crown-to-heel length of 25 cm. Within this category, ICD classifies late fetal deaths (greater than 1000 g or after 28 weeks) and early fetal deaths (500–1000 g or 22–28 weeks). The legal requirements for registration of fetal deaths vary between and even within countries. WHO recommends that, if possible, all fetuses and infants weighing at least 500 g at birth, whether alive or dead, should be included in the statistics. The inclusion in national statistics of fetuses and infants weighing between 500 g and 1000 g is recommended both because of its inherent value and because it improves the coverage of reporting at 1000 g and over <xref rid="bib0580" ref-type="bibr">[5]</xref>, <xref rid="bib0590" ref-type="bibr">[7]</xref>.</td></tr><tr><td align="left">WHO/ICD (for International comparison and reporting)</td><td align="left">≥28 0/7</td><td align="char">≥1000</td><td align="char">≥35</td><td align="left">The WHO recommends using the higher limit (1000 g/28 weeks/35 cm) of third-trimester stillbirths for international comparisons and reporting <xref rid="bib0580" ref-type="bibr">[5]</xref>, <xref rid="bib0590" ref-type="bibr">[7]</xref>.</td></tr><tr><td align="left">EMA</td><td align="left">≥22 0/7</td><td></td><td></td><td align="left">The European Medicines Agency (EMA) uses the term stillbirth as the synonym of late fetal death, which is the death after 22 completed weeks of gestation <xref rid="bib1065" ref-type="bibr">[102]</xref></td></tr><tr><td align="left">NICHD – SCRN US, VPDC Australia</td><td align="left">≥20 0/7</td><td align="char">≥400</td><td></td><td align="left">The Stillbirth Collaborative Research Network (SCRN) defines stillbirth as Fetal death at ≥20 completed weeks of gestation or ≥400 g birth weight. In Australia, stillbirth is also defined as fetal death (no signs of life), whether antepartum or intrapartum, at ≥20 weeks of gestation or ≥400 g birthweight, if gestational age is unknown, and it must be registered <xref rid="bib1070" ref-type="bibr">[103]</xref>, <xref rid="bib1075" ref-type="bibr">[104]</xref>.</td></tr><tr><td align="left">ACOG (US)</td><td align="left">≥20 0/7</td><td align="char">≥350</td><td></td><td align="left">The American College of Obstetricians and Gynecologists (ACOG) defines stillbirth as delivery of fetus which shows no signs of life e.g. absence of breathing, heart beats, pulsations in umbilical cord are absent, no voluntary movement of muscle. The suggested requirement is to report fetal deaths at 20 weeks or greater of gestation (if the gestational age is known) or a weight greater than or equal to 350 g if the gestational age is not known. The cut-off of 350 g is the 50th percentile for weight at 20 weeks gestation <xref rid="bib0565" ref-type="bibr">[2]</xref>.</td></tr><tr><td align="left">UK</td><td align="left">≥24 0/7</td><td></td><td></td><td align="left">The United Kingdom defines stillbirth as fetal death at 24 or more completed weeks of gestation <xref rid="bib1080" ref-type="bibr">[105]</xref>, <xref rid="bib1085" ref-type="bibr">[106]</xref>.</td></tr></tbody></table></table-wrap></floats-group></pmc><affiliations><list><country><li>Australie</li><li>Belgique</li><li>France</li><li>Inde</li><li>Royaume-Uni</li><li>États-Unis</li></country><region><li>Auvergne-Rhône-Alpes</li><li>Kentucky</li><li>Massachusetts</li><li>Michigan</li><li>Rhône-Alpes</li><li>Texas</li><li>Washington (État)</li></region><settlement><li>Lyon</li></settlement></list><tree><country name="Belgique"><noRegion><name sortKey="Da Silva, Fernanda Tavares" sort="Da Silva, Fernanda Tavares" uniqKey="Da Silva F" first="Fernanda Tavares" last="Da Silva">Fernanda Tavares Da Silva</name></noRegion></country><country name="États-Unis"><region name="Michigan"><name sortKey="Gonik, Bernard" sort="Gonik, Bernard" uniqKey="Gonik B" first="Bernard" last="Gonik">Bernard Gonik</name></region><name sortKey="Harper, Diana M" sort="Harper, Diana M" uniqKey="Harper D" first="Diana M." last="Harper">Diana M. Harper</name><name sortKey="Kawai, Alison Tse" sort="Kawai, Alison Tse" uniqKey="Kawai A" first="Alison Tse" last="Kawai">Alison Tse Kawai</name><name sortKey="Keech, Cheryl" sort="Keech, Cheryl" uniqKey="Keech C" first="Cheryl" last="Keech">Cheryl Keech</name><name sortKey="Munoz, Flor M" sort="Munoz, Flor M" uniqKey="Munoz F" first="Flor M." last="Munoz">Flor M. Munoz</name><name sortKey="Woods, Charles" sort="Woods, Charles" uniqKey="Woods C" first="Charles" last="Woods">Charles Woods</name></country><country name="Australie"><noRegion><name sortKey="Mcmillan, Mark" sort="Mcmillan, Mark" uniqKey="Mcmillan M" first="Mark" last="Mcmillan">Mark Mcmillan</name></noRegion></country><country name="Royaume-Uni"><noRegion><name sortKey="Dellicour, Stephanie" sort="Dellicour, Stephanie" uniqKey="Dellicour S" first="Stephanie" last="Dellicour">Stephanie Dellicour</name></noRegion></country><country name="Inde"><noRegion><name sortKey="Bhange, Shraddha" sort="Bhange, Shraddha" uniqKey="Bhange S" first="Shraddha" last="Bhange">Shraddha Bhange</name></noRegion><name sortKey="Kochhar, Sonali" sort="Kochhar, Sonali" uniqKey="Kochhar S" first="Sonali" last="Kochhar">Sonali Kochhar</name></country><country name="France"><region name="Auvergne-Rhône-Alpes"><name sortKey="Tila, Mihaela" sort="Tila, Mihaela" uniqKey="Tila M" first="Mihaela" last="Tila">Mihaela Tila</name></region></country></tree></affiliations></record>Pour manipuler ce document sous Unix (Dilib)
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