Detecting congenital malformations - Lessons learned from the Mpepu study, Botswana
Identifieur interne : 000328 ( Pmc/Checkpoint ); précédent : 000327; suivant : 000329Detecting congenital malformations - Lessons learned from the Mpepu study, Botswana
Auteurs : Gbolahan Ajibola [Botswana] ; Rebecca Zash [Botswana, États-Unis] ; Roger L. Shapiro [Botswana, États-Unis] ; Oganne Batlang [Botswana] ; Kerapetse Botebele [Botswana] ; Kara Bennett [États-Unis] ; Florence Chilisa [Botswana] ; Erik Von Widenfelt [Botswana] ; Joseph Makhema [Botswana] ; Shahin Lockman [Botswana, États-Unis] ; Lewis B. Holmes [États-Unis] ; Kathleen M. Powis [Botswana, États-Unis]Source :
- PLoS ONE [ 1932-6203 ] ; 2017.
Abstract
A large and increasing number of HIV-infected women are conceiving on antiretroviral treatment (ART). While most antiretrovirals are considered safe in pregnancy, monitoring for rare pregnancy and infant adverse outcomes is warranted.
We conducted a retrospective secondary analysis nested within a clinical trial of infant cotrimoxazole vs. placebo prophylaxis in Botswana (the Mpepu Study). Infants were examined at birth, and at least every 3 months through 18 months of age. Abnormal physical findings and diagnostic testing revealing malformations were documented. Post hoc, a geneticist classified all reported malformations based on available documentation. Structural malformations with surgical, medical or cosmetic importance were classified as major malformations. We present a descriptive analysis of identified malformations.
Between 2011 and 2014, 2,933 HIV-infected women who enrolled in the Mpepu study delivered 2,971 live-born infants. Study staff conducted 2,944 (99%) newborn exams. One thousand eighty-eight (38%) women were taking ART at conception; 1,147 (40%) started ART during pregnancy; 442 (15%) received zidovudine monotherapy; and 223 (7%) received no antiretroviral during pregnancy. Of 33 reported anomalies, 25 (76%) met congenital malformations criteria, 10 (30%) were classified as major malformations, 4 (40%) of which were identified after the birth exam.
Our results highlight the importance of staff training on identification of congenital malformations, programmatic monitoring beyond the birth examination and the value of geneticist involvement in the malformations classification process in resource-limited settings. These elements will be important to fully define antiretroviral drug safety in pregnancy.
Surveillance systems for monitoring the safety of antiretroviral use during pregnancy among HIV-infected women in resource-limited setting are lacking. The World Health Organization’s published programmatic recommendations for such surveillance systems represents the gold standard. We employed data from a clinical trial in Botswana, a country with a generalized HIV epidemic and high antiretroviral uptake by HIV-infected women, to highlight practical opportunities to strengthen congenital malformation surveillance systems in these settings where over 1 million HIV infected pregnant women reside.
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DOI: 10.1371/journal.pone.0173800
PubMed: 28339500
PubMed Central: 5365099
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<record><TEI><teiHeader><fileDesc><titleStmt><title xml:lang="en">Detecting congenital malformations - Lessons learned from the Mpepu study, Botswana</title><author><name sortKey="Ajibola, Gbolahan" sort="Ajibola, Gbolahan" uniqKey="Ajibola G" first="Gbolahan" last="Ajibola">Gbolahan Ajibola</name><affiliation wicri:level="1"><nlm:aff id="aff001"><addr-line>Botswana Harvard AIDS Institute Partnership, Gaborone, Botswana</addr-line></nlm:aff><country xml:lang="fr">Botswana</country><wicri:regionArea>Botswana Harvard AIDS Institute Partnership, Gaborone</wicri:regionArea><wicri:noRegion>Gaborone</wicri:noRegion></affiliation></author><author><name sortKey="Zash, Rebecca" sort="Zash, Rebecca" uniqKey="Zash R" first="Rebecca" last="Zash">Rebecca Zash</name><affiliation wicri:level="1"><nlm:aff id="aff001"><addr-line>Botswana Harvard AIDS Institute Partnership, Gaborone, Botswana</addr-line></nlm:aff><country xml:lang="fr">Botswana</country><wicri:regionArea>Botswana Harvard AIDS Institute Partnership, Gaborone</wicri:regionArea><wicri:noRegion>Gaborone</wicri:noRegion></affiliation><affiliation wicri:level="2"><nlm:aff id="aff002"><addr-line>Division of Infectious Diseases, Beth Israel Deaconess Medical Center, Boston, Massachusetts, United States of America</addr-line></nlm:aff><country xml:lang="fr">États-Unis</country><wicri:regionArea>Division of Infectious Diseases, Beth Israel Deaconess Medical Center, Boston, Massachusetts</wicri:regionArea><placeName><region type="state">Massachusetts</region></placeName></affiliation><affiliation wicri:level="2"><nlm:aff id="aff003"><addr-line>Department of Immunology and Infectious Diseases, Harvard T.H. Chan School of Public Health, Boston, Massachusetts, United States of America</addr-line></nlm:aff><country xml:lang="fr">États-Unis</country><wicri:regionArea>Department of Immunology and Infectious Diseases, Harvard T.H. Chan School of Public Health, Boston, Massachusetts</wicri:regionArea><placeName><region type="state">Massachusetts</region></placeName></affiliation></author><author><name sortKey="Shapiro, Roger L" sort="Shapiro, Roger L" uniqKey="Shapiro R" first="Roger L." last="Shapiro">Roger L. Shapiro</name><affiliation wicri:level="1"><nlm:aff id="aff001"><addr-line>Botswana Harvard AIDS Institute Partnership, Gaborone, Botswana</addr-line></nlm:aff><country xml:lang="fr">Botswana</country><wicri:regionArea>Botswana Harvard AIDS Institute Partnership, Gaborone</wicri:regionArea><wicri:noRegion>Gaborone</wicri:noRegion></affiliation><affiliation wicri:level="2"><nlm:aff id="aff003"><addr-line>Department of Immunology and Infectious Diseases, Harvard T.H. Chan School of Public Health, Boston, Massachusetts, United States of America</addr-line></nlm:aff><country xml:lang="fr">États-Unis</country><wicri:regionArea>Department of Immunology and Infectious Diseases, Harvard T.H. 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Chan School of Public Health, Boston, Massachusetts, United States of America</addr-line></nlm:aff><country xml:lang="fr">États-Unis</country><wicri:regionArea>Department of Immunology and Infectious Diseases, Harvard T.H. Chan School of Public Health, Boston, Massachusetts</wicri:regionArea><placeName><region type="state">Massachusetts</region></placeName></affiliation><affiliation wicri:level="2"><nlm:aff id="aff005"><addr-line>Infectious Disease Unit, Brigham and Women's Hospital, Boston, Massachusetts, United States of America</addr-line></nlm:aff><country xml:lang="fr">États-Unis</country><wicri:regionArea>Infectious Disease Unit, Brigham and Women's Hospital, Boston, Massachusetts</wicri:regionArea><placeName><region type="state">Massachusetts</region></placeName></affiliation></author><author><name sortKey="Holmes, Lewis B" sort="Holmes, Lewis B" uniqKey="Holmes L" first="Lewis B." last="Holmes">Lewis B. 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Chan School of Public Health, Boston, Massachusetts, United States of America</addr-line></nlm:aff><country xml:lang="fr">États-Unis</country><wicri:regionArea>Department of Immunology and Infectious Diseases, Harvard T.H. Chan School of Public Health, Boston, Massachusetts</wicri:regionArea><placeName><region type="state">Massachusetts</region></placeName></affiliation></author><author><name sortKey="Shapiro, Roger L" sort="Shapiro, Roger L" uniqKey="Shapiro R" first="Roger L." last="Shapiro">Roger L. Shapiro</name><affiliation wicri:level="1"><nlm:aff id="aff001"><addr-line>Botswana Harvard AIDS Institute Partnership, Gaborone, Botswana</addr-line></nlm:aff><country xml:lang="fr">Botswana</country><wicri:regionArea>Botswana Harvard AIDS Institute Partnership, Gaborone</wicri:regionArea><wicri:noRegion>Gaborone</wicri:noRegion></affiliation><affiliation wicri:level="2"><nlm:aff id="aff003"><addr-line>Department of Immunology and Infectious Diseases, Harvard T.H. Chan School of Public Health, Boston, Massachusetts, United States of America</addr-line></nlm:aff><country xml:lang="fr">États-Unis</country><wicri:regionArea>Department of Immunology and Infectious Diseases, Harvard T.H. Chan School of Public Health, Boston, Massachusetts</wicri:regionArea><placeName><region type="state">Massachusetts</region></placeName></affiliation></author><author><name sortKey="Batlang, Oganne" sort="Batlang, Oganne" uniqKey="Batlang O" first="Oganne" last="Batlang">Oganne Batlang</name><affiliation wicri:level="1"><nlm:aff id="aff001"><addr-line>Botswana Harvard AIDS Institute Partnership, Gaborone, Botswana</addr-line></nlm:aff><country xml:lang="fr">Botswana</country><wicri:regionArea>Botswana Harvard AIDS Institute Partnership, Gaborone</wicri:regionArea><wicri:noRegion>Gaborone</wicri:noRegion></affiliation></author><author><name sortKey="Botebele, Kerapetse" sort="Botebele, Kerapetse" uniqKey="Botebele K" first="Kerapetse" last="Botebele">Kerapetse Botebele</name><affiliation wicri:level="1"><nlm:aff id="aff001"><addr-line>Botswana Harvard AIDS Institute Partnership, Gaborone, Botswana</addr-line></nlm:aff><country xml:lang="fr">Botswana</country><wicri:regionArea>Botswana Harvard AIDS Institute Partnership, Gaborone</wicri:regionArea><wicri:noRegion>Gaborone</wicri:noRegion></affiliation></author><author><name sortKey="Bennett, Kara" sort="Bennett, Kara" uniqKey="Bennett K" first="Kara" last="Bennett">Kara Bennett</name><affiliation wicri:level="2"><nlm:aff id="aff004"><addr-line>Bennett Statistical Consulting, Inc., Ballston Lake, New York, United States of America</addr-line></nlm:aff><country xml:lang="fr">États-Unis</country><wicri:regionArea>Bennett Statistical Consulting, Inc., Ballston Lake, New York</wicri:regionArea><placeName><region type="state">État de New York</region></placeName></affiliation></author><author><name sortKey="Chilisa, Florence" sort="Chilisa, Florence" uniqKey="Chilisa F" first="Florence" last="Chilisa">Florence Chilisa</name><affiliation wicri:level="1"><nlm:aff id="aff001"><addr-line>Botswana Harvard AIDS Institute Partnership, Gaborone, Botswana</addr-line></nlm:aff><country xml:lang="fr">Botswana</country><wicri:regionArea>Botswana Harvard AIDS Institute Partnership, Gaborone</wicri:regionArea><wicri:noRegion>Gaborone</wicri:noRegion></affiliation></author><author><name sortKey="Von Widenfelt, Erik" sort="Von Widenfelt, Erik" uniqKey="Von Widenfelt E" first="Erik" last="Von Widenfelt">Erik Von Widenfelt</name><affiliation wicri:level="1"><nlm:aff id="aff001"><addr-line>Botswana Harvard AIDS Institute Partnership, Gaborone, Botswana</addr-line></nlm:aff><country xml:lang="fr">Botswana</country><wicri:regionArea>Botswana Harvard AIDS Institute Partnership, Gaborone</wicri:regionArea><wicri:noRegion>Gaborone</wicri:noRegion></affiliation></author><author><name sortKey="Makhema, Joseph" sort="Makhema, Joseph" uniqKey="Makhema J" first="Joseph" last="Makhema">Joseph Makhema</name><affiliation wicri:level="1"><nlm:aff id="aff001"><addr-line>Botswana Harvard AIDS Institute Partnership, Gaborone, Botswana</addr-line></nlm:aff><country xml:lang="fr">Botswana</country><wicri:regionArea>Botswana Harvard AIDS Institute Partnership, Gaborone</wicri:regionArea><wicri:noRegion>Gaborone</wicri:noRegion></affiliation></author><author><name sortKey="Lockman, Shahin" sort="Lockman, Shahin" uniqKey="Lockman S" first="Shahin" last="Lockman">Shahin Lockman</name><affiliation wicri:level="1"><nlm:aff id="aff001"><addr-line>Botswana Harvard AIDS Institute Partnership, Gaborone, Botswana</addr-line></nlm:aff><country xml:lang="fr">Botswana</country><wicri:regionArea>Botswana Harvard AIDS Institute Partnership, Gaborone</wicri:regionArea><wicri:noRegion>Gaborone</wicri:noRegion></affiliation><affiliation wicri:level="2"><nlm:aff id="aff003"><addr-line>Department of Immunology and Infectious Diseases, Harvard T.H. Chan School of Public Health, Boston, Massachusetts, United States of America</addr-line></nlm:aff><country xml:lang="fr">États-Unis</country><wicri:regionArea>Department of Immunology and Infectious Diseases, Harvard T.H. Chan School of Public Health, Boston, Massachusetts</wicri:regionArea><placeName><region type="state">Massachusetts</region></placeName></affiliation><affiliation wicri:level="2"><nlm:aff id="aff005"><addr-line>Infectious Disease Unit, Brigham and Women's Hospital, Boston, Massachusetts, United States of America</addr-line></nlm:aff><country xml:lang="fr">États-Unis</country><wicri:regionArea>Infectious Disease Unit, Brigham and Women's Hospital, Boston, Massachusetts</wicri:regionArea><placeName><region type="state">Massachusetts</region></placeName></affiliation></author><author><name sortKey="Holmes, Lewis B" sort="Holmes, Lewis B" uniqKey="Holmes L" first="Lewis B." last="Holmes">Lewis B. Holmes</name><affiliation wicri:level="2"><nlm:aff id="aff006"><addr-line>Genetics Unit, MassGeneral Hospital for Children, Boston, Massachusetts, United States of America</addr-line></nlm:aff><country xml:lang="fr">États-Unis</country><wicri:regionArea>Genetics Unit, MassGeneral Hospital for Children, Boston, Massachusetts</wicri:regionArea><placeName><region type="state">Massachusetts</region></placeName></affiliation></author><author><name sortKey="Powis, Kathleen M" sort="Powis, Kathleen M" uniqKey="Powis K" first="Kathleen M" last="Powis">Kathleen M. Powis</name><affiliation wicri:level="1"><nlm:aff id="aff001"><addr-line>Botswana Harvard AIDS Institute Partnership, Gaborone, Botswana</addr-line></nlm:aff><country xml:lang="fr">Botswana</country><wicri:regionArea>Botswana Harvard AIDS Institute Partnership, Gaborone</wicri:regionArea><wicri:noRegion>Gaborone</wicri:noRegion></affiliation><affiliation wicri:level="2"><nlm:aff id="aff003"><addr-line>Department of Immunology and Infectious Diseases, Harvard T.H. Chan School of Public Health, Boston, Massachusetts, United States of America</addr-line></nlm:aff><country xml:lang="fr">États-Unis</country><wicri:regionArea>Department of Immunology and Infectious Diseases, Harvard T.H. Chan School of Public Health, Boston, Massachusetts</wicri:regionArea><placeName><region type="state">Massachusetts</region></placeName></affiliation><affiliation wicri:level="2"><nlm:aff id="aff007"><addr-line>Department of Internal Medicine, Massachusetts General Hospital, Boston, Massachusetts, United States of America</addr-line></nlm:aff><country xml:lang="fr">États-Unis</country><wicri:regionArea>Department of Internal Medicine, Massachusetts General Hospital, Boston, Massachusetts</wicri:regionArea><placeName><region type="state">Massachusetts</region></placeName></affiliation><affiliation wicri:level="2"><nlm:aff id="aff008"><addr-line>Global Health, MassGeneral Hospital for Children, Boston, Massachusetts, United States of America</addr-line></nlm:aff><country xml:lang="fr">États-Unis</country><wicri:regionArea>Global Health, MassGeneral Hospital for Children, Boston, Massachusetts</wicri:regionArea><placeName><region type="state">Massachusetts</region></placeName></affiliation></author></analytic><series><title level="j">PLoS ONE</title><idno type="eISSN">1932-6203</idno><imprint><date when="2017">2017</date></imprint></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en"><sec id="sec001"><title>Introduction</title><p>A large and increasing number of HIV-infected women are conceiving on antiretroviral treatment (ART). While most antiretrovirals are considered safe in pregnancy, monitoring for rare pregnancy and infant adverse outcomes is warranted.</p></sec><sec id="sec002"><title>Methods</title><p>We conducted a retrospective secondary analysis nested within a clinical trial of infant cotrimoxazole vs. placebo prophylaxis in Botswana (the Mpepu Study). Infants were examined at birth, and at least every 3 months through 18 months of age. Abnormal physical findings and diagnostic testing revealing malformations were documented. Post hoc, a geneticist classified all reported malformations based on available documentation. Structural malformations with surgical, medical or cosmetic importance were classified as major malformations. We present a descriptive analysis of identified malformations.</p></sec><sec id="sec003"><title>Results</title><p>Between 2011 and 2014, 2,933 HIV-infected women who enrolled in the Mpepu study delivered 2,971 live-born infants. Study staff conducted 2,944 (99%) newborn exams. One thousand eighty-eight (38%) women were taking ART at conception; 1,147 (40%) started ART during pregnancy; 442 (15%) received zidovudine monotherapy; and 223 (7%) received no antiretroviral during pregnancy. Of 33 reported anomalies, 25 (76%) met congenital malformations criteria, 10 (30%) were classified as major malformations, 4 (40%) of which were identified after the birth exam.</p></sec><sec id="sec004"><title>Discussion</title><p>Our results highlight the importance of staff training on identification of congenital malformations, programmatic monitoring beyond the birth examination and the value of geneticist involvement in the malformations classification process in resource-limited settings. These elements will be important to fully define antiretroviral drug safety in pregnancy.</p></sec><sec id="sec005"><title>Significance</title><p>Surveillance systems for monitoring the safety of antiretroviral use during pregnancy among HIV-infected women in resource-limited setting are lacking. The World Health Organization’s published programmatic recommendations for such surveillance systems represents the gold standard. We employed data from a clinical trial in Botswana, a country with a generalized HIV epidemic and high antiretroviral uptake by HIV-infected women, to highlight practical opportunities to strengthen congenital malformation surveillance systems in these settings where over 1 million HIV infected pregnant women reside.</p></sec><sec id="sec006"><title>Trial registration</title><p>Clinical Trials.gov <ext-link ext-link-type="uri" xlink:href="https://clinicaltrials.gov/ct2/show/NCT01229761">NCT01229761</ext-link></p></sec></div></front><back><div1 type="bibliography"><listBibl><biblStruct></biblStruct><biblStruct><analytic><author><name sortKey="Shapiro, Rl" uniqKey="Shapiro R">RL Shapiro</name></author><author><name sortKey="Hughes, M" uniqKey="Hughes M">M Hughes</name></author><author><name sortKey="Ogwu, A" uniqKey="Ogwu A">A Ogwu</name></author><author><name sortKey="Kitch, D" uniqKey="Kitch D">D Kitch</name></author><author><name sortKey="Lockman, S" uniqKey="Lockman S">S Lockman</name></author><author><name sortKey="Moffatt, C" uniqKey="Moffatt C">C Moffatt</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Marazzi, Mc" uniqKey="Marazzi M">MC Marazzi</name></author><author><name sortKey="Nielsen Saines, K" uniqKey="Nielsen Saines K">K Nielsen-Saines</name></author><author><name sortKey="Buonomo, E" uniqKey="Buonomo E">E Buonomo</name></author><author><name sortKey="Scarcella, P" uniqKey="Scarcella P">P Scarcella</name></author><author><name sortKey="Germano, P" uniqKey="Germano P">P Germano</name></author><author><name sortKey="Majid, Ma" uniqKey="Majid M">MA Majid</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="De Vincenzi, I" uniqKey="De Vincenzi I">I de Vincenzi</name></author><author><name sortKey="Farley, T" uniqKey="Farley T">T Farley</name></author><author><name sortKey="Gaillard, P" uniqKey="Gaillard P">P Gaillard</name></author><author><name sortKey="Meda, N" uniqKey="Meda N">N Meda</name></author><author><name sortKey="Rollins, N" uniqKey="Rollins N">N Rollins</name></author><author><name sortKey="Luchters, S" uniqKey="Luchters S">S Luchters</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Chasela, Cs" uniqKey="Chasela C">CS Chasela</name></author><author><name sortKey="Hudgens, Mg" uniqKey="Hudgens M">MG Hudgens</name></author><author><name sortKey="Jamieson, Dj" uniqKey="Jamieson D">DJ Jamieson</name></author><author><name sortKey="Kayira, D" uniqKey="Kayira D">D Kayira</name></author><author><name sortKey="Hosseinipour, Mc" uniqKey="Hosseinipour M">MC Hosseinipour</name></author><author><name sortKey="Kourtis, Ap" uniqKey="Kourtis A">AP Kourtis</name></author></analytic></biblStruct><biblStruct></biblStruct><biblStruct><analytic><author><name sortKey="Thang, Meow Keong" uniqKey="Thang M">Meow-Keong Thang</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Sitkin, Na" uniqKey="Sitkin N">NA Sitkin</name></author><author><name sortKey="Ozgetiz, D" uniqKey="Ozgetiz D">D Ozgetiz</name></author><author><name sortKey="Donkor, P" uniqKey="Donkor P">P Donkor</name></author><author><name sortKey="Farmer, Dl" uniqKey="Farmer D">DL Farmer</name></author></analytic></biblStruct><biblStruct></biblStruct><biblStruct><analytic><author><name sortKey="Holmes, Lb" uniqKey="Holmes L">LB Holmes</name></author><author><name sortKey="Westage, Mn" uniqKey="Westage M">MN Westage</name></author></analytic></biblStruct><biblStruct></biblStruct><biblStruct><analytic><author><name sortKey="Smith, Se" uniqKey="Smith S">SE Smith</name></author><author><name sortKey="Ludwig, Jt" uniqKey="Ludwig J">JT Ludwig</name></author><author><name sortKey="Chinchilli, Vm" uniqKey="Chinchilli V">VM Chinchilli</name></author><author><name sortKey="Mehta, K" uniqKey="Mehta K">K Mehta</name></author><author><name sortKey="Stoute, Ja" uniqKey="Stoute J">JA Stoute</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Ramogola Masire, D" uniqKey="Ramogola Masire D">D Ramogola-Masire</name></author><author><name sortKey="De Klerk, R" uniqKey="De Klerk R">R de Klerk</name></author><author><name sortKey="Monare, B" uniqKey="Monare B">B Monare</name></author><author><name sortKey="Ratshaa, B" uniqKey="Ratshaa B">B Ratshaa</name></author><author><name sortKey="Friedman, H" uniqKey="Friedman H">H Friedman</name></author><author><name sortKey="Zetola, Nm" uniqKey="Zetola N">NM Zetola</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Gulley, Ml" uniqKey="Gulley M">ML Gulley</name></author><author><name sortKey="Morgan, Dr" uniqKey="Morgan D">DR Morgan</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Busby, A" uniqKey="Busby A">A Busby</name></author><author><name sortKey="Ritvanen, A" uniqKey="Ritvanen A">A Ritvanen</name></author><author><name sortKey="Dolk, H" uniqKey="Dolk H">H Dolk</name></author><author><name sortKey="Armstrong, N" uniqKey="Armstrong N">N Armstrong</name></author><author><name sortKey="De Walle, H" uniqKey="De Walle H">H De Walle</name></author><author><name sortKey="Riano Galan, I" uniqKey="Riano Galan I">I Riano-Galan</name></author></analytic></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct><analytic><author><name sortKey="Mofenson, Lm" uniqKey="Mofenson L">LM Mofenson</name></author><author><name sortKey="Watts, Dh" uniqKey="Watts D">DH Watts</name></author></analytic></biblStruct></listBibl></div1></back></TEI><pmc article-type="research-article"><pmc-dir>properties open_access</pmc-dir>
<front><journal-meta><journal-id journal-id-type="nlm-ta">PLoS One</journal-id><journal-id journal-id-type="iso-abbrev">PLoS ONE</journal-id><journal-id journal-id-type="publisher-id">plos</journal-id><journal-id journal-id-type="pmc">plosone</journal-id><journal-title-group><journal-title>PLoS ONE</journal-title></journal-title-group><issn pub-type="epub">1932-6203</issn><publisher><publisher-name>Public Library of Science</publisher-name><publisher-loc>San Francisco, CA USA</publisher-loc></publisher></journal-meta><article-meta><article-id pub-id-type="pmid">28339500</article-id><article-id pub-id-type="pmc">5365099</article-id><article-id pub-id-type="doi">10.1371/journal.pone.0173800</article-id><article-id pub-id-type="publisher-id">PONE-D-16-40353</article-id><article-categories><subj-group subj-group-type="heading"><subject>Research Article</subject></subj-group><subj-group subj-group-type="Discipline-v3"><subject>Medicine and Health Sciences</subject><subj-group><subject>Congenital Disorders</subject><subj-group><subject>Congenital Anomalies</subject></subj-group></subj-group></subj-group><subj-group subj-group-type="Discipline-v3"><subject>People and Places</subject><subj-group><subject>Population Groupings</subject><subj-group><subject>Age Groups</subject><subj-group><subject>Children</subject><subj-group><subject>Infants</subject></subj-group></subj-group></subj-group></subj-group></subj-group><subj-group subj-group-type="Discipline-v3"><subject>People and Places</subject><subj-group><subject>Population Groupings</subject><subj-group><subject>Families</subject><subj-group><subject>Children</subject><subj-group><subject>Infants</subject></subj-group></subj-group></subj-group></subj-group></subj-group><subj-group subj-group-type="Discipline-v3"><subject>Medicine and Health Sciences</subject><subj-group><subject>Women's Health</subject><subj-group><subject>Maternal Health</subject><subj-group><subject>Pregnancy</subject></subj-group></subj-group></subj-group></subj-group><subj-group subj-group-type="Discipline-v3"><subject>Medicine and Health Sciences</subject><subj-group><subject>Women's Health</subject><subj-group><subject>Obstetrics and Gynecology</subject><subj-group><subject>Pregnancy</subject></subj-group></subj-group></subj-group></subj-group><subj-group subj-group-type="Discipline-v3"><subject>Medicine and Health Sciences</subject><subj-group><subject>Women's Health</subject><subj-group><subject>Maternal Health</subject><subj-group><subject>Birth</subject></subj-group></subj-group></subj-group></subj-group><subj-group subj-group-type="Discipline-v3"><subject>Medicine and Health Sciences</subject><subj-group><subject>Women's Health</subject><subj-group><subject>Obstetrics and Gynecology</subject><subj-group><subject>Birth</subject></subj-group></subj-group></subj-group></subj-group><subj-group subj-group-type="Discipline-v3"><subject>Medicine and Health Sciences</subject><subj-group><subject>Pharmacology</subject><subj-group><subject>Drugs</subject><subj-group><subject>Antimicrobials</subject><subj-group><subject>Antivirals</subject><subj-group><subject>Antiretrovirals</subject></subj-group></subj-group></subj-group></subj-group></subj-group></subj-group><subj-group subj-group-type="Discipline-v3"><subject>Biology and Life Sciences</subject><subj-group><subject>Microbiology</subject><subj-group><subject>Microbial Control</subject><subj-group><subject>Antimicrobials</subject><subj-group><subject>Antivirals</subject><subj-group><subject>Antiretrovirals</subject></subj-group></subj-group></subj-group></subj-group></subj-group></subj-group><subj-group subj-group-type="Discipline-v3"><subject>Biology and Life Sciences</subject><subj-group><subject>Microbiology</subject><subj-group><subject>Virology</subject><subj-group><subject>Antivirals</subject><subj-group><subject>Antiretrovirals</subject></subj-group></subj-group></subj-group></subj-group></subj-group><subj-group subj-group-type="Discipline-v3"><subject>Biology and Life Sciences</subject><subj-group><subject>Immunology</subject><subj-group><subject>Vaccination and Immunization</subject><subj-group><subject>Antiviral Therapy</subject><subj-group><subject>Antiretroviral Therapy</subject></subj-group></subj-group></subj-group></subj-group></subj-group><subj-group subj-group-type="Discipline-v3"><subject>Medicine and Health Sciences</subject><subj-group><subject>Immunology</subject><subj-group><subject>Vaccination and Immunization</subject><subj-group><subject>Antiviral Therapy</subject><subj-group><subject>Antiretroviral Therapy</subject></subj-group></subj-group></subj-group></subj-group></subj-group><subj-group subj-group-type="Discipline-v3"><subject>Medicine and Health Sciences</subject><subj-group><subject>Public and Occupational Health</subject><subj-group><subject>Preventive Medicine</subject><subj-group><subject>Vaccination and Immunization</subject><subj-group><subject>Antiviral Therapy</subject><subj-group><subject>Antiretroviral Therapy</subject></subj-group></subj-group></subj-group></subj-group></subj-group></subj-group><subj-group subj-group-type="Discipline-v3"><subject>People and Places</subject><subj-group><subject>Geographical Locations</subject><subj-group><subject>Africa</subject><subj-group><subject>Botswana</subject></subj-group></subj-group></subj-group></subj-group><subj-group subj-group-type="Discipline-v3"><subject>Medicine and Health Sciences</subject><subj-group><subject>Women's Health</subject><subj-group><subject>Obstetrics and Gynecology</subject><subj-group><subject>Assisted Reproductive Technology</subject></subj-group></subj-group></subj-group></subj-group></article-categories><title-group><article-title>Detecting congenital malformations - Lessons learned from the Mpepu study, Botswana</article-title><alt-title alt-title-type="running-head">Detecting congenital malformations</alt-title></title-group><contrib-group><contrib contrib-type="author"><contrib-id authenticated="true" contrib-id-type="orcid">http://orcid.org/0000-0002-5408-4823</contrib-id><name><surname>Ajibola</surname><given-names>Gbolahan</given-names></name><xref ref-type="aff" rid="aff001"><sup>1</sup></xref><xref ref-type="corresp" rid="cor001">*</xref></contrib><contrib contrib-type="author"><name><surname>Zash</surname><given-names>Rebecca</given-names></name><xref ref-type="aff" rid="aff001"><sup>1</sup></xref><xref ref-type="aff" rid="aff002"><sup>2</sup></xref><xref ref-type="aff" rid="aff003"><sup>3</sup></xref></contrib><contrib contrib-type="author"><name><surname>Shapiro</surname><given-names>Roger L.</given-names></name><xref ref-type="aff" rid="aff001"><sup>1</sup></xref><xref ref-type="aff" rid="aff003"><sup>3</sup></xref></contrib><contrib contrib-type="author"><name><surname>Batlang</surname><given-names>Oganne</given-names></name><xref ref-type="aff" rid="aff001"><sup>1</sup></xref></contrib><contrib contrib-type="author"><name><surname>Botebele</surname><given-names>Kerapetse</given-names></name><xref ref-type="aff" rid="aff001"><sup>1</sup></xref></contrib><contrib contrib-type="author"><name><surname>Bennett</surname><given-names>Kara</given-names></name><xref ref-type="aff" rid="aff004"><sup>4</sup></xref></contrib><contrib contrib-type="author"><name><surname>Chilisa</surname><given-names>Florence</given-names></name><xref ref-type="aff" rid="aff001"><sup>1</sup></xref></contrib><contrib contrib-type="author"><name><surname>von Widenfelt</surname><given-names>Erik</given-names></name><xref ref-type="aff" rid="aff001"><sup>1</sup></xref></contrib><contrib contrib-type="author"><name><surname>Makhema</surname><given-names>Joseph</given-names></name><xref ref-type="aff" rid="aff001"><sup>1</sup></xref></contrib><contrib contrib-type="author"><name><surname>Lockman</surname><given-names>Shahin</given-names></name><xref ref-type="aff" rid="aff001"><sup>1</sup></xref><xref ref-type="aff" rid="aff003"><sup>3</sup></xref><xref ref-type="aff" rid="aff005"><sup>5</sup></xref></contrib><contrib contrib-type="author"><name><surname>Holmes</surname><given-names>Lewis B.</given-names></name><xref ref-type="aff" rid="aff006"><sup>6</sup></xref></contrib><contrib contrib-type="author"><name><surname>Powis</surname><given-names>Kathleen M</given-names></name><xref ref-type="aff" rid="aff001"><sup>1</sup></xref><xref ref-type="aff" rid="aff003"><sup>3</sup></xref><xref ref-type="aff" rid="aff007"><sup>7</sup></xref><xref ref-type="aff" rid="aff008"><sup>8</sup></xref></contrib></contrib-group><aff id="aff001"><label>1</label><addr-line>Botswana Harvard AIDS Institute Partnership, Gaborone, Botswana</addr-line></aff><aff id="aff002"><label>2</label><addr-line>Division of Infectious Diseases, Beth Israel Deaconess Medical Center, Boston, Massachusetts, United States of America</addr-line></aff><aff id="aff003"><label>3</label><addr-line>Department of Immunology and Infectious Diseases, Harvard T.H. Chan School of Public Health, Boston, Massachusetts, United States of America</addr-line></aff><aff id="aff004"><label>4</label><addr-line>Bennett Statistical Consulting, Inc., Ballston Lake, New York, United States of America</addr-line></aff><aff id="aff005"><label>5</label><addr-line>Infectious Disease Unit, Brigham and Women's Hospital, Boston, Massachusetts, United States of America</addr-line></aff><aff id="aff006"><label>6</label><addr-line>Genetics Unit, MassGeneral Hospital for Children, Boston, Massachusetts, United States of America</addr-line></aff><aff id="aff007"><label>7</label><addr-line>Department of Internal Medicine, Massachusetts General Hospital, Boston, Massachusetts, United States of America</addr-line></aff><aff id="aff008"><label>8</label><addr-line>Global Health, MassGeneral Hospital for Children, Boston, Massachusetts, United States of America</addr-line></aff><contrib-group><contrib contrib-type="editor"><name><surname>De Socio</surname><given-names>Giuseppe Vittorio</given-names></name><role>Editor</role><xref ref-type="aff" rid="edit1"></xref></contrib></contrib-group><aff id="edit1"><addr-line>Azienda Ospedaliera Universitaria di Perugia, ITALY</addr-line></aff><author-notes><fn fn-type="COI-statement" id="coi001"><p><bold>Competing Interests: </bold>Co-author Kara Bennett was sub-contracted to provide statistical support for the study. The sub-contract services provided by Bennett Consulting, Inc, did not alter our adherence to PLOS ONE policies on sharing data and materials. in our cover letter to the editor as advised. No co-author has a competing interest in the areas of employment, consultancy, patents, products in development, or marketed products.</p></fn><fn fn-type="con"><p><list list-type="simple"><list-item><p><bold>Conceptualization:</bold> GA KMP RLS SL.</p></list-item><list-item><p><bold>Data curation:</bold> KB EvW FC GA KMP.</p></list-item><list-item><p><bold>Formal analysis:</bold> KB GA KMP.</p></list-item><list-item><p><bold>Funding acquisition:</bold> KMP RLS.</p></list-item><list-item><p><bold>Investigation:</bold> GA KMP OB KB SL RLS.</p></list-item><list-item><p><bold>Methodology:</bold> GA KMP SL RLS.</p></list-item><list-item><p><bold>Project administration:</bold> GA KMP SL RLS JM.</p></list-item><list-item><p><bold>Resources:</bold> GA KMP RZ OB KB SL RLS JM.</p></list-item><list-item><p><bold>Software:</bold> GA KMP FC EvW KB.</p></list-item><list-item><p><bold>Supervision:</bold> RLS SL LBH KMP.</p></list-item><list-item><p><bold>Validation:</bold> GA KMP LBH.</p></list-item><list-item><p><bold>Visualization:</bold> GA KMP KB SL RLS.</p></list-item><list-item><p><bold>Writing – original draft:</bold> GA KMP RLS SL LBH.</p></list-item><list-item><p><bold>Writing – review & editing:</bold> GA KMP KB LBH JM RLS SL.</p></list-item></list></p></fn><corresp id="cor001">* E-mail: <email>gajibola@bhp.org.bw</email></corresp></author-notes><pub-date pub-type="epub"><day>24</day><month>3</month><year>2017</year></pub-date><pub-date pub-type="collection"><year>2017</year></pub-date><volume>12</volume><issue>3</issue><elocation-id>e0173800</elocation-id><history><date date-type="received"><day>12</day><month>10</month><year>2016</year></date><date date-type="accepted"><day>23</day><month>2</month><year>2017</year></date></history><permissions><license xlink:href="https://creativecommons.org/publicdomain/zero/1.0/"><license-p>This is an open access article, free of all copyright, and may be freely reproduced, distributed, transmitted, modified, built upon, or otherwise used by anyone for any lawful purpose. The work is made available under the <ext-link ext-link-type="uri" xlink:href="https://creativecommons.org/publicdomain/zero/1.0/">Creative Commons CC0</ext-link> public domain dedication.</license-p></license></permissions><self-uri content-type="pdf" xlink:href="pone.0173800.pdf"></self-uri><abstract><sec id="sec001"><title>Introduction</title><p>A large and increasing number of HIV-infected women are conceiving on antiretroviral treatment (ART). While most antiretrovirals are considered safe in pregnancy, monitoring for rare pregnancy and infant adverse outcomes is warranted.</p></sec><sec id="sec002"><title>Methods</title><p>We conducted a retrospective secondary analysis nested within a clinical trial of infant cotrimoxazole vs. placebo prophylaxis in Botswana (the Mpepu Study). Infants were examined at birth, and at least every 3 months through 18 months of age. Abnormal physical findings and diagnostic testing revealing malformations were documented. Post hoc, a geneticist classified all reported malformations based on available documentation. Structural malformations with surgical, medical or cosmetic importance were classified as major malformations. We present a descriptive analysis of identified malformations.</p></sec><sec id="sec003"><title>Results</title><p>Between 2011 and 2014, 2,933 HIV-infected women who enrolled in the Mpepu study delivered 2,971 live-born infants. Study staff conducted 2,944 (99%) newborn exams. One thousand eighty-eight (38%) women were taking ART at conception; 1,147 (40%) started ART during pregnancy; 442 (15%) received zidovudine monotherapy; and 223 (7%) received no antiretroviral during pregnancy. Of 33 reported anomalies, 25 (76%) met congenital malformations criteria, 10 (30%) were classified as major malformations, 4 (40%) of which were identified after the birth exam.</p></sec><sec id="sec004"><title>Discussion</title><p>Our results highlight the importance of staff training on identification of congenital malformations, programmatic monitoring beyond the birth examination and the value of geneticist involvement in the malformations classification process in resource-limited settings. These elements will be important to fully define antiretroviral drug safety in pregnancy.</p></sec><sec id="sec005"><title>Significance</title><p>Surveillance systems for monitoring the safety of antiretroviral use during pregnancy among HIV-infected women in resource-limited setting are lacking. The World Health Organization’s published programmatic recommendations for such surveillance systems represents the gold standard. We employed data from a clinical trial in Botswana, a country with a generalized HIV epidemic and high antiretroviral uptake by HIV-infected women, to highlight practical opportunities to strengthen congenital malformation surveillance systems in these settings where over 1 million HIV infected pregnant women reside.</p></sec><sec id="sec006"><title>Trial registration</title><p>Clinical Trials.gov <ext-link ext-link-type="uri" xlink:href="https://clinicaltrials.gov/ct2/show/NCT01229761">NCT01229761</ext-link></p></sec></abstract><funding-group><award-group id="award001"><funding-source><institution-wrap><institution-id institution-id-type="funder-id">http://dx.doi.org/10.13039/100000071</institution-id><institution>National Institute of Child Health and Human Development</institution></institution-wrap></funding-source><award-id>R01HD061265</award-id><principal-award-recipient><name><surname>Shapiro</surname><given-names>Roger L</given-names></name></principal-award-recipient></award-group><award-group id="award002"><funding-source><institution-wrap><institution-id institution-id-type="funder-id">http://dx.doi.org/10.13039/100000071</institution-id><institution>National Institute of Child Health and Human Development</institution></institution-wrap></funding-source><award-id>K23 HD070774</award-id><principal-award-recipient><name><surname>Powis</surname><given-names>Kathleen M</given-names></name></principal-award-recipient></award-group><funding-statement>The Mpepu study was supported by funding from the National Institute of Child Health and Human Development and the National Institute of Allergy and Infectious Diseases (R01 HD061265). The funder only provided support for the conduct of the study and in the form of salaries for authors [GA, RLS, OB, KB, FC, EvW, JM, SL, and KMP], but did not have any additional role in the study design, data collection and analysis, decision to publish, or preparation of the manuscript. KMP also received salary support from the National Institute of Child Health and Human Development (K23 HD070774). KB, of Bennett Statistical Consulting, was contracted by the study to provide statistical support and assisted with data analysis and manuscript preparation, but did not contribute to study design or data collection.</funding-statement></funding-group><counts><fig-count count="1"></fig-count><table-count count="2"></table-count><page-count count="10"></page-count></counts><custom-meta-group><custom-meta id="data-availability"><meta-name>Data Availability</meta-name><meta-value>The congenital anomalies reported in our manuscript are rare events and publication would place the families of these infants at risks for personal identification, including their HIV status. Therefore, a full dataset cannot be made publicly available. These data are available at the Botswana Harvard AIDS research Institute partnership and the Harvard T.H Chan School of public health Institutional Data Access for researchers who meet the criteria for access to confidential data. Request for use of our Data should be made to RLS through the email address below <email>rshapiro999@gmail.com</email> Trial registrations: Clinical Trials.gov Registration Number: NCT01229761.</meta-value></custom-meta></custom-meta-group></article-meta><notes><title>Data Availability</title><p>The congenital anomalies reported in our manuscript are rare events and publication would place the families of these infants at risks for personal identification, including their HIV status. Therefore, a full dataset cannot be made publicly available. These data are available at the Botswana Harvard AIDS research Institute partnership and the Harvard T.H Chan School of public health Institutional Data Access for researchers who meet the criteria for access to confidential data. Request for use of our Data should be made to RLS through the email address below <email>rshapiro999@gmail.com</email> Trial registrations: Clinical Trials.gov Registration Number: NCT01229761.</p></notes></front></pmc><affiliations><list><country><li>Botswana</li><li>États-Unis</li></country><region><li>Massachusetts</li><li>État de New York</li></region></list><tree><country name="Botswana"><noRegion><name sortKey="Ajibola, Gbolahan" sort="Ajibola, Gbolahan" uniqKey="Ajibola G" first="Gbolahan" last="Ajibola">Gbolahan Ajibola</name></noRegion><name sortKey="Batlang, Oganne" sort="Batlang, Oganne" uniqKey="Batlang O" first="Oganne" last="Batlang">Oganne Batlang</name><name sortKey="Botebele, Kerapetse" sort="Botebele, Kerapetse" uniqKey="Botebele K" first="Kerapetse" last="Botebele">Kerapetse Botebele</name><name sortKey="Chilisa, Florence" sort="Chilisa, Florence" uniqKey="Chilisa F" first="Florence" last="Chilisa">Florence Chilisa</name><name sortKey="Lockman, Shahin" sort="Lockman, Shahin" uniqKey="Lockman S" first="Shahin" last="Lockman">Shahin Lockman</name><name sortKey="Makhema, Joseph" sort="Makhema, Joseph" uniqKey="Makhema J" first="Joseph" last="Makhema">Joseph Makhema</name><name sortKey="Powis, Kathleen M" sort="Powis, Kathleen M" uniqKey="Powis K" first="Kathleen M" last="Powis">Kathleen M. Powis</name><name sortKey="Shapiro, Roger L" sort="Shapiro, Roger L" uniqKey="Shapiro R" first="Roger L." last="Shapiro">Roger L. Shapiro</name><name sortKey="Von Widenfelt, Erik" sort="Von Widenfelt, Erik" uniqKey="Von Widenfelt E" first="Erik" last="Von Widenfelt">Erik Von Widenfelt</name><name sortKey="Zash, Rebecca" sort="Zash, Rebecca" uniqKey="Zash R" first="Rebecca" last="Zash">Rebecca Zash</name></country><country name="États-Unis"><region name="Massachusetts"><name sortKey="Zash, Rebecca" sort="Zash, Rebecca" uniqKey="Zash R" first="Rebecca" last="Zash">Rebecca Zash</name></region><name sortKey="Bennett, Kara" sort="Bennett, Kara" uniqKey="Bennett K" first="Kara" last="Bennett">Kara Bennett</name><name sortKey="Holmes, Lewis B" sort="Holmes, Lewis B" uniqKey="Holmes L" first="Lewis B." last="Holmes">Lewis B. Holmes</name><name sortKey="Lockman, Shahin" sort="Lockman, Shahin" uniqKey="Lockman S" first="Shahin" last="Lockman">Shahin Lockman</name><name sortKey="Lockman, Shahin" sort="Lockman, Shahin" uniqKey="Lockman S" first="Shahin" last="Lockman">Shahin Lockman</name><name sortKey="Powis, Kathleen M" sort="Powis, Kathleen M" uniqKey="Powis K" first="Kathleen M" last="Powis">Kathleen M. Powis</name><name sortKey="Powis, Kathleen M" sort="Powis, Kathleen M" uniqKey="Powis K" first="Kathleen M" last="Powis">Kathleen M. Powis</name><name sortKey="Powis, Kathleen M" sort="Powis, Kathleen M" uniqKey="Powis K" first="Kathleen M" last="Powis">Kathleen M. Powis</name><name sortKey="Shapiro, Roger L" sort="Shapiro, Roger L" uniqKey="Shapiro R" first="Roger L." last="Shapiro">Roger L. Shapiro</name><name sortKey="Zash, Rebecca" sort="Zash, Rebecca" uniqKey="Zash R" first="Rebecca" last="Zash">Rebecca Zash</name></country></tree></affiliations></record>Pour manipuler ce document sous Unix (Dilib)
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