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<record><TEI><teiHeader><fileDesc><titleStmt><title xml:lang="en">Elective cesarean section for women living with HIV: a systematic review of risks and benefits</title><author><name sortKey="Kennedy, Caitlin E" sort="Kennedy, Caitlin E" uniqKey="Kennedy C" first="Caitlin E." last="Kennedy">Caitlin E. Kennedy</name><affiliation><nlm:aff id="aff1">Department of International Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland, USA</nlm:aff></affiliation></author><author><name sortKey="Yeh, Ping T" sort="Yeh, Ping T" uniqKey="Yeh P" first="Ping T." last="Yeh">Ping T. Yeh</name><affiliation><nlm:aff id="aff1">Department of International Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland, USA</nlm:aff></affiliation></author><author><name sortKey="Pandey, Shristi" sort="Pandey, Shristi" uniqKey="Pandey S" first="Shristi" last="Pandey">Shristi Pandey</name><affiliation><nlm:aff id="aff1">Department of International Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland, USA</nlm:aff></affiliation></author><author><name sortKey="Betran, Ana P" sort="Betran, Ana P" uniqKey="Betran A" first="Ana P." last="Betran">Ana P. Betran</name><affiliation><nlm:aff id="aff2">Department of Reproductive Health and Research, World Health Organization, including the UNDP, UNFPA, UNICEF, WHO, World Bank, Special Programme of Research, Development and Research Training in Human Reproduction (HRP), Geneva, Switzerland.</nlm:aff></affiliation></author><author><name sortKey="Narasimhan, Manjulaa" sort="Narasimhan, Manjulaa" uniqKey="Narasimhan M" first="Manjulaa" last="Narasimhan">Manjulaa Narasimhan</name><affiliation><nlm:aff id="aff2">Department of Reproductive Health and Research, World Health Organization, including the UNDP, UNFPA, UNICEF, WHO, World Bank, Special Programme of Research, Development and Research Training in Human Reproduction (HRP), Geneva, Switzerland.</nlm:aff></affiliation></author></titleStmt><publicationStmt><idno type="wicri:source">PMC</idno><idno type="pmid">28481770</idno><idno type="pmc">5491238</idno><idno type="url">http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5491238</idno><idno type="RBID">PMC:5491238</idno><idno type="doi">10.1097/QAD.0000000000001535</idno><date when="2017">2017</date><idno type="wicri:Area/Pmc/Corpus">002120</idno><idno type="wicri:explorRef" wicri:stream="Pmc" wicri:step="Corpus" wicri:corpus="PMC">002120</idno></publicationStmt><sourceDesc><biblStruct><analytic><title xml:lang="en" level="a" type="main">Elective cesarean section for women living with HIV: a systematic review of risks and benefits</title><author><name sortKey="Kennedy, Caitlin E" sort="Kennedy, Caitlin E" uniqKey="Kennedy C" first="Caitlin E." last="Kennedy">Caitlin E. Kennedy</name><affiliation><nlm:aff id="aff1">Department of International Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland, USA</nlm:aff></affiliation></author><author><name sortKey="Yeh, Ping T" sort="Yeh, Ping T" uniqKey="Yeh P" first="Ping T." last="Yeh">Ping T. Yeh</name><affiliation><nlm:aff id="aff1">Department of International Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland, USA</nlm:aff></affiliation></author><author><name sortKey="Pandey, Shristi" sort="Pandey, Shristi" uniqKey="Pandey S" first="Shristi" last="Pandey">Shristi Pandey</name><affiliation><nlm:aff id="aff1">Department of International Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland, USA</nlm:aff></affiliation></author><author><name sortKey="Betran, Ana P" sort="Betran, Ana P" uniqKey="Betran A" first="Ana P." last="Betran">Ana P. Betran</name><affiliation><nlm:aff id="aff2">Department of Reproductive Health and Research, World Health Organization, including the UNDP, UNFPA, UNICEF, WHO, World Bank, Special Programme of Research, Development and Research Training in Human Reproduction (HRP), Geneva, Switzerland.</nlm:aff></affiliation></author><author><name sortKey="Narasimhan, Manjulaa" sort="Narasimhan, Manjulaa" uniqKey="Narasimhan M" first="Manjulaa" last="Narasimhan">Manjulaa Narasimhan</name><affiliation><nlm:aff id="aff2">Department of Reproductive Health and Research, World Health Organization, including the UNDP, UNFPA, UNICEF, WHO, World Bank, Special Programme of Research, Development and Research Training in Human Reproduction (HRP), Geneva, Switzerland.</nlm:aff></affiliation></author></analytic><series><title level="j">AIDS (London, England)</title><idno type="ISSN">0269-9370</idno><idno type="eISSN">1473-5571</idno><imprint><date when="2017">2017</date></imprint></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en"><p>Supplemental Digital Content is available in the text</p></div></front><back><div1 type="bibliography"><listBibl><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct><analytic><author><name sortKey="Calvert, C" uniqKey="Calvert C">C Calvert</name></author><author><name sortKey="Ronsmans, C" uniqKey="Ronsmans C">C Ronsmans</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Read, Js" uniqKey="Read J">JS Read</name></author><author><name sortKey="Newell, Mk" uniqKey="Newell M">MK Newell</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Orza, L" uniqKey="Orza L">L Orza</name></author><author><name sortKey="Welbourn, A" uniqKey="Welbourn A">A Welbourn</name></author><author><name sortKey="Bewley, S" 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<front><journal-meta><journal-id journal-id-type="nlm-ta">AIDS</journal-id><journal-id journal-id-type="iso-abbrev">AIDS</journal-id><journal-id journal-id-type="publisher-id">AIDS</journal-id><journal-title-group><journal-title>AIDS (London, England)</journal-title></journal-title-group><issn pub-type="ppub">0269-9370</issn><issn pub-type="epub">1473-5571</issn><publisher><publisher-name>Lippincott Williams & Wilkins</publisher-name></publisher></journal-meta><article-meta><article-id pub-id-type="pmid">28481770</article-id><article-id pub-id-type="pmc">5491238</article-id><article-id pub-id-type="publisher-id">AIDS-D-17-00008</article-id><article-id pub-id-type="doi">10.1097/QAD.0000000000001535</article-id><article-id pub-id-type="art-access-id">00010</article-id><article-categories><subj-group subj-group-type="heading"><subject>Epidemiology and Social</subject></subj-group></article-categories><title-group><article-title>Elective cesarean section for women living with HIV: a systematic review of risks and benefits</article-title></title-group><contrib-group><contrib contrib-type="author"><name><surname>Kennedy</surname><given-names>Caitlin E.</given-names></name><xref ref-type="aff" rid="aff1"><sup>a</sup></xref></contrib><contrib contrib-type="author"><name><surname>Yeh</surname><given-names>Ping T.</given-names></name><xref ref-type="aff" rid="aff1"><sup>a</sup></xref></contrib><contrib contrib-type="author"><name><surname>Pandey</surname><given-names>Shristi</given-names></name><xref ref-type="aff" rid="aff1"><sup>a</sup></xref></contrib><contrib contrib-type="author"><name><surname>Betran</surname><given-names>Ana P.</given-names></name><xref ref-type="aff" rid="aff2"><sup>b</sup></xref></contrib><contrib contrib-type="author"><name><surname>Narasimhan</surname><given-names>Manjulaa</given-names></name><xref ref-type="aff" rid="aff2"><sup>b</sup></xref></contrib></contrib-group><aff id="aff1"><label>a</label>Department of International Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland, USA</aff><aff id="aff2"><label>b</label>Department of Reproductive Health and Research, World Health Organization, including the UNDP, UNFPA, UNICEF, WHO, World Bank, Special Programme of Research, Development and Research Training in Human Reproduction (HRP), Geneva, Switzerland.</aff><author-notes><corresp>Correspondence to Caitlin E. Kennedy, PhD, Department of International Health, Johns Hopkins Bloomberg School of Public Health, 615 N. Wolfe Street, Room E5547, Baltimore, MD 21205, USA. Tel: +1 443 287 8794; e-mail: <email>caitlinkennedy@jhu.edu</email></corresp></author-notes><pub-date pub-type="ppub"><day>17</day><month>7</month><year>2017</year></pub-date><pub-date pub-type="epub"><day>28</day><month>6</month><year>2017</year></pub-date><volume>31</volume><issue>11</issue><fpage>1579</fpage><lpage>1591</lpage><history><date date-type="received"><day>22</day><month>12</month><year>2016</year></date><date date-type="rev-recd"><day>27</day><month>4</month><year>2017</year></date><date date-type="accepted"><day>02</day><month>5</month><year>2017</year></date></history><permissions><copyright-statement>Copyright © 2017 The Author(s). Published by Wolters Kluwer Health, Inc.</copyright-statement><copyright-year>2017</copyright-year><license license-type="open-access" xlink:href="http://creativecommons.org/licenses/by/4.0"><license-p>This is an open access article distributed under the Creative Commons Attribution License 4.0 (CCBY), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. <ext-link ext-link-type="uri" xlink:href="http://creativecommons.org/licenses/by/4.0">http://creativecommons.org/licenses/by/4.0</ext-link></license-p></license></permissions><self-uri xlink:type="simple" xlink:href="aids-31-1579.pdf"></self-uri><abstract abstract-type="toc"><p>Supplemental Digital Content is available in the text</p></abstract><abstract><sec><title>Objective and design:</title><p>To inform WHO guidelines, we conducted a systematic review and meta-analysis to assess maternal and perinatal outcomes comparing cesarean section (c-section) before labor and rupture of membranes [elective c-section (ECS)] with other modes of delivery for women living with HIV.</p></sec><sec sec-type="methods"><title>Methods:</title><p>We searched PubMed, CINAHL, Embase, CENTRAL, and previous reviews to identify published trials and observational studies through October 2015. Results were synthesized using random-effects meta-analysis, stratifying for combination antiretroviral therapy (cART), CD4<sup>+</sup>/viral load (VL), delivery at term, and low-income/middle-income countries.</p></sec><sec sec-type="results"><title>Results:</title><p>From 2567 citations identified, 36 articles met inclusion criteria. The single randomized trial, published in 1999, reported minimal maternal morbidity and significantly fewer infant HIV infections with ECS [odds ratio (OR) 0.2, 95% confidence interval (CI) 0.0–0.5]. Across observational studies, ECS was associated with increased maternal morbidity compared with vaginal delivery (OR 3.12, 95% CI 2.21–4.41). ECS was also associated with decreased infant HIV infection overall (OR 0.43, 95% CI 0.30–0.63) and in low-income/middle-income countries (OR 0.27, 95% CI 0.16–0.45), but not among women on cART (OR 0.82, 95% CI 0.47–1.43) or with CD4<sup>+</sup> cell count more than 200/VL less than 400/term delivery (OR 0.59, 95% CI 0.21–1.63). Infant morbidity moderately increased with ECS.</p></sec><sec sec-type="conclusion"><title>Conclusion:</title><p>Although ECS may reduce infant HIV infection, this effect was not statistically significant in the context of cART and viral suppression. As ECS poses other risks, routine ECS for all women living with HIV may not be appropriate. Risks and benefits will differ across settings, depending on underlying risks of ECS complications and vertical transmission during delivery. Understanding individual client risks and benefits and respecting women's autonomy remain important.</p></sec></abstract><kwd-group><title>Keywords</title><kwd>cesarean-section</kwd><kwd>elective cesarean-section</kwd><kwd>maternal health</kwd><kwd>mode of delivery</kwd><kwd>mother-to-child transmission</kwd><kwd>reproductive health</kwd><kwd>vertical transmission</kwd></kwd-group><custom-meta-group><custom-meta><meta-name>OPEN-ACCESS</meta-name><meta-value>TRUE</meta-value></custom-meta><custom-meta><meta-name>SDC</meta-name><meta-value>T</meta-value></custom-meta></custom-meta-group></article-meta></front><body><sec sec-type="intro"><title>Introduction</title><p>Cesarean section (c-section) before labor and before rupture of membranes [elective c-section (ECS)] has been suggested as an intervention to prevent vertical transmission of HIV in high-income settings where training and resources exist to conduct c-sections safely [<xref rid="R1" ref-type="bibr">1</xref>]. The decision to offer ECS to women living with HIV must consider a range of potential risks as well as benefits for both the mother and the child. These risks and benefits vary depending on the underlying risk of vertical transmission of HIV during delivery, which is associated with disease stage and antiretroviral treatment (ART) use [<xref rid="R2" ref-type="bibr">2</xref>], as well as on the underlying risks of ECS compared with vaginal delivery for both mother and child, which is associated with the local capacity and skills to perform c-sections and treat potential complications [<xref rid="R3" ref-type="bibr">3</xref>]. Unfortunately, many women in low-income and middle-income countries (LMICs), in particular, lack access to high-quality obstetric services, a critical concern in the context of rising c-section rates globally [<xref rid="R3" ref-type="bibr">3</xref>]. Furthermore, women living with HIV may experience higher rates of some obstetric complications compared with HIV-uninfected women [<xref rid="R4" ref-type="bibr">4</xref>].</p><p>In 2005, Read and Newell published a Cochrane systematic review, which identified one clinical trial and five observational studies evaluating the safety of ECS versus vaginal delivery among HIV-1-infected women [<xref rid="R5" ref-type="bibr">5</xref>]. Taken together, these studies indicated that ECS can substantially reduce the risk of mother to child HIV transmission, whereas it also resulted in slightly higher rates of postpartum maternal morbidity, such morbidity was generally rated as minor [<xref rid="R5" ref-type="bibr">5</xref>]. The authors concluded that in general, the benefit of ECS outweighs the risks, but the risk-to-benefit ratio depends upon the underlying rate of vertical HIV transmission [<xref rid="R5" ref-type="bibr">5</xref>].</p><p>There were several limitations to the data available at the time of the Read and Newell review [<xref rid="R5" ref-type="bibr">5</xref>] as well as to its interpretation and applicability 12 years later. The single trial included only HIV-1-infected women taking no ART during pregnancy or taking only zidovudine. In addition to this, HIV infection, no infant outcomes were measured in any of the included studies. Furthermore, all studies were conducted in high-income countries in Europe or North America, where ECS is a relatively safe procedure. The vast majority of women living with HIV live in sub-Saharan Africa and other LMIC settings, where higher rates of morbidity and mortality may be ascribed to the c-section surgery itself. Since the single trial, published in 1999 with data collected in the mid-1990s, ART use has expanded greatly worldwide, and more effective regimens have been developed. In 2015, the WHO recommended offering immediate ART to all individuals living with HIV [<xref rid="R2" ref-type="bibr">2</xref>]. These actions should significantly reduce vertical HIV transmission.</p><p>Women living with HIV have the right to the most up-to-date knowledge about risks and benefits of sexual and reproductive health decisions they will make, with the support of their healthcare providers [<xref rid="R6" ref-type="bibr">6</xref>]. To inform WHO recommendations on the sexual and reproductive health and rights of women living with HIV, we sought to update the Read and Newell review [<xref rid="R5" ref-type="bibr">5</xref>] to consider the current existing evidence on ECS for women living with HIV globally.</p></sec><sec sec-type="methods"><title>Methods</title><p>This systematic review and meta-analysis followed Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines [<xref rid="R7" ref-type="bibr">7</xref>,<xref rid="R8" ref-type="bibr">8</xref>] to answer the question: does ECS in women living with HIV result in better maternal and perinatal outcomes than other modes of delivery?</p><sec><title>Inclusion/exclusion criteria</title><p>To be included in the review, an article had to present primary research comparing outcomes of ECS to other modes of delivery (e.g. non-ECS, vaginal delivery) among women living with HIV and their children; measure any of the following outcomes: morbidity and mortality among women [e.g. febrile morbidity, endometritis, hemorrhage or severe anemia, pneumonia, urinary tract infections (UTIs)], HIV infection in infants (efficacy of prevention of vertical transmission), other morbidity and mortality among infants (e.g., respiratory morbidity and skin lacerations), or breastfeeding (success or timing of initiation and continuation); and be published in a peer-reviewed journal prior to the search date of 1 October 2015. Analytic epidemiologic studies, both observational (case–control and cohort studies) and interventional (clinical trials), were included; ecological and historical-control studies were not. Mode of delivery had to be explicitly described. Studies from any geographical location including any women living with HIV of childbearing age were eligible for inclusion. Studies published in all languages were eligible for inclusion.</p><p>For this review, we defined ECS as a c-section conducted before start of labor and before rupture of membranes. However, we included any study that used the term ECS, without requiring further definition by study authors. We similarly accepted author-provided definitions for all outcomes.</p></sec><sec><title>Search strategy</title><p>We searched four electronic databases: PubMed, CINAHL, Embase, and the Cochrane Central Register of Controlled Trials (CENTRAL). For each online database, we used the following search strategy: (HIV OR AIDS) AND (‘mode of delivery’ or ‘cesarean section’ or ‘cesarean section’ or ‘c-section’). We conducted secondary reference searching on all included studies and the previous Read and Newell review [<xref rid="R5" ref-type="bibr">5</xref>].</p><p>Titles, abstracts, citation information, and descriptor terms of citations identified through the search strategy were screened by a member of the study staff. When a citation was considered relevant or when title/abstract was deemed insufficient for inclusion/exclusion decision, the full-texts were retrieved and evaluated. Two reviewers (independently and in duplicate) assessed all full-text articles for eligibility to determine final study selection. Differences were resolved through consensus.</p></sec><sec><title>Data extraction and quality assessment</title><p>Data were extracted by two reviewers using standardized forms. Differences in data extraction were resolved through discussion and referral to a senior study team member when necessary. The following information was gathered from each included study:<list list-type="simple"><list-item><label>(1)</label><p>Study description: Study objectives; year(s); location (country/city); setting (population-based, hospital, clinic); study design; sample size; recruitment and allocation methods; follow-up periods; loss to follow-up</p></list-item><list-item><label>(2)</label><p>Population characteristics: Age, socioeconomic status; HIV disease stage; CD4<sup>+</sup> cell count; VL; ART status/regimen; comorbidities (e.g., diabetes); obstetric characteristics</p></list-item><list-item><label>(3)</label><p>Intervention: Mode of delivery; method of determination (e.g., medical records, survey self-report)</p></list-item><list-item><label>(4)</label><p>Outcomes: Analytic approach; outcome measures and definitions (including both maternal and neonatal outcomes); comparison groups; effect sizes; confidence intervals (CIs); significance levels</p></list-item></list></p><p>Authors were contacted for additional clarification if information in published articles was insufficient.</p><p>For randomized controlled trials (RCTs), risk of bias was assessed using the Cochrane Collaboration's tool [<xref rid="R9" ref-type="bibr">9</xref>]. This tool assesses random sequence generation (selection bias), allocation concealment (selection bias), blinding of participants and personnel (performance bias), blinding of outcome assessment (detection bias), incomplete outcome data addressed (attrition bias), and selective reporting (reporting bias). Methodological components of the studies were classified as high or low risk of bias. For observational studies using different designs, we adapted the Newcastle–Ottawa scale to consider measures of study quality [<xref rid="R10" ref-type="bibr">10</xref>].</p></sec><sec><title>Analysis</title><p>We examined results of ECS compared with both vaginal delivery and all other modes of delivery (non-ECS, forceps-assisted or vacuum-assisted delivery, etc.). Although vaginal delivery is the main comparison of interest, in observational studies, this comparison excludes women with medical indications for emergency or non-ECS, potentially biasing results. We therefore also present data for all other modes of delivery.</p><p>Where multiple studies reported the same outcome among comparable populations with adequate data, meta-analysis was conducted using random-effects models to combine odds ratios (ORs) using the program Comprehensive Meta-Analysis [<xref rid="R11" ref-type="bibr">11</xref>]. Heterogeneity was assessed using the <italic>I</italic><sup>2</sup> statistic and interpreted according to Cochrane thresholds [<xref rid="R12" ref-type="bibr">12</xref>], and funnel plots were created to examine the potential for publication bias. In meta-analyses, we did not combine data from trials with data from observational studies, as results were expected to differ systematically, resulting in increased heterogeneity [<xref rid="R12" ref-type="bibr">12</xref>]. We attempted to identify overlapping participant data across articles by contacting study authors to avoid combining articles with overlapping data in meta-analysis. In cases of overlap, we included only the most recent or comprehensive data in meta-analysis. We conducted stratified analyses for studies conducted in the combination antiretroviral therapy (cART) era (defined as after 1996 or cART use in country). We also conducted stratified analyses of data from women who were on cART and women who had higher CD4<sup>+</sup> cell counts or lower VLs (defined as CD4<sup>+</sup> cell count > 200 cells/μl or VL < 400 RNA copies/ml). We then further stratified for women in these categories who delivered their pregnancies at term (at or >37 weeks of gestation) (i.e. cART patients delivering at term, and women with CD4<sup>+</sup> cell count > 200 cells/μl or VL < 400 RNA copies/ml and delivering at term). Finally, we conducted stratified analyses of data from studies conducted in LMICs, as classified by the World Bank [<xref rid="R13" ref-type="bibr">13</xref>].</p></sec></sec><sec sec-type="results"><title>Results</title><sec><title>Description of included studies</title><p>Figure <xref ref-type="fig" rid="F1">1</xref> presents a study selection flowchart. The initial database search yielded 2565 records, with two records identified through other sources; 1750 remained after removing duplicates. After the initial title/abstract review, 64 articles were retained for full-text screening. Ultimately, 36 articles met the inclusion criteria and were included in the review [<xref rid="R14" ref-type="bibr">14</xref>–<xref rid="R49" ref-type="bibr">49</xref>]. Seventeen were published in 2005 or later (after the cutoff date of the previous review).</p><fig id="F1" position="float"><label>Fig. 1</label><caption><p>PRISMA flow diagram outlining the article search and selection process.</p></caption><graphic xlink:href="aids-31-1579-g001"></graphic></fig><p>Table <xref ref-type="table" rid="T1">1</xref> presents selected characteristics of the 36 included articles. These articles came from approximately 17 different studies; studies overlapped significantly as several long-term cohorts published updated findings, and some contributors to the European Collaborative Study published country-specific cohort subanalyses. Ultimately, data from 25 articles were considered nonoverlapping and are included in the analyses presented below. Settings were mostly in Europe, including data from Belgium, Denmark, France, Germany, Italy, the Netherlands, Poland, Romania, Spain, Sweden, Ukraine, and the United Kingdom. Four studies were conducted in the United States and two in India. One multicountry study (reported in two articles) was conducted in Latin America, whereas individual studies were conducted in Brazil, South Africa, Nigeria, and Kenya.</p><table-wrap id="T1" position="float"><label>Table 1</label><caption><p>Randomized controlled trials and observational studies comparing modes of delivery among women living with HIV.</p></caption><table frame="hsides" rules="groups"><thead><tr><td rowspan="1" colspan="1">Study name</td><td rowspan="1" colspan="1">First author and year of publication</td><td rowspan="1" colspan="1">Study years</td><td rowspan="1" colspan="1">Study location (country)</td><td rowspan="1" colspan="1">Study design</td><td rowspan="1" colspan="1">Sample size (overall)</td><td rowspan="1" colspan="1">Follow-up period</td><td rowspan="1" colspan="1">Outcome(s)</td></tr></thead><tbody><tr><td rowspan="1" colspan="1">European Collaborative Study</td><td rowspan="1" colspan="1">Bailey 1999 [<xref rid="R14" ref-type="bibr">14</xref>]</td><td rowspan="1" colspan="1">1987–1998</td><td rowspan="1" colspan="1">Belgium, Germany, Italy, Netherlands, Spain, Sweden, United Kingdom</td><td rowspan="1" colspan="1">Prospective cohort</td><td rowspan="1" colspan="1">364 women, 373 pregnancies</td><td rowspan="1" colspan="1">18 months</td><td rowspan="1" colspan="1">Infant HIV transmission</td></tr><tr><td rowspan="1" colspan="1">European Collaborative Study</td><td rowspan="1" colspan="1">European Collaborative Study 2005 [<xref rid="R20" ref-type="bibr">20</xref>]</td><td rowspan="1" colspan="1">1985–2004</td><td rowspan="1" colspan="1">Belgium, Denmark, Germany, Italy, Netherlands, Poland, Spain, Sweden, United Kingdom</td><td rowspan="1" colspan="1">Prospective cohort</td><td rowspan="1" colspan="1">4525 mother–child pairs</td><td rowspan="1" colspan="1">18 months</td><td rowspan="1" colspan="1">Infant HIV transmission</td></tr><tr><td rowspan="1" colspan="1">European Collaborative Study</td><td rowspan="1" colspan="1">European Collaborative Study 2010 [<xref rid="R16" ref-type="bibr">16</xref>]</td><td rowspan="1" colspan="1">1985–2007</td><td rowspan="1" colspan="1">Belgium, Denmark, Germany, Italy, Netherlands, Poland, Spain, Sweden, Ukraine, United Kingdom</td><td rowspan="1" colspan="1">Prospective cohort</td><td rowspan="1" colspan="1">5238 mother–child pairs</td><td rowspan="1" colspan="1">18 months</td><td rowspan="1" colspan="1">Infant HIV transmission</td></tr><tr><td rowspan="1" colspan="1">European Collaborative Study</td><td rowspan="1" colspan="1">Newell 1994 [<xref rid="R39" ref-type="bibr">39</xref>]</td><td rowspan="1" colspan="1">1986–1992</td><td rowspan="1" colspan="1">Belgium, Germany, Italy, Netherlands, Spain, Sweden, United Kingdom</td><td rowspan="1" colspan="1">Prospective cohort</td><td rowspan="1" colspan="1">1254 mother–child pairs</td><td rowspan="1" colspan="1">18 months</td><td rowspan="1" colspan="1">Infant HIV transmission</td></tr><tr><td rowspan="1" colspan="1">European Collaborative Study</td><td rowspan="1" colspan="1">Newell 1996 [<xref rid="R40" ref-type="bibr">40</xref>]</td><td rowspan="1" colspan="1">1986–1995</td><td rowspan="1" colspan="1">Belgium, Germany, Italy, Netherlands, Spain, Sweden, United Kingdom</td><td rowspan="1" colspan="1">Prospective cohort</td><td rowspan="1" colspan="1">1846 mothers, 1945 children</td><td rowspan="1" colspan="1">18 months</td><td rowspan="1" colspan="1">Infant HIV transmission</td></tr><tr><td rowspan="1" colspan="1">European Collaborative Study</td><td rowspan="1" colspan="1">Thorne 2004 [<xref rid="R45" ref-type="bibr">45</xref>]</td><td rowspan="1" colspan="1">1986–2003</td><td rowspan="1" colspan="1">Belgium, Denmark, Germany, Italy, Netherlands, Poland, Spain, Sweden, United Kingdom</td><td rowspan="1" colspan="1">Prospective cohort</td><td rowspan="1" colspan="1">3231 mother–child pairs</td><td rowspan="1" colspan="1">18 months</td><td rowspan="1" colspan="1">Infant HIV transmission</td></tr><tr><td rowspan="1" colspan="1">European Collaborative Study/European HIV in Obstetrics Group</td><td rowspan="1" colspan="1">Fiore 2004 [<xref rid="R22" ref-type="bibr">22</xref>]</td><td rowspan="1" colspan="1">1992–2002</td><td rowspan="1" colspan="1">Italy, Spain, Sweden, Poland, Ukraine</td><td rowspan="1" colspan="1">Case-control</td><td rowspan="1" colspan="1">408 women</td><td rowspan="1" colspan="1">N/A</td><td rowspan="1" colspan="1">Maternal morbidities</td></tr><tr><td rowspan="1" colspan="1">European Collaborative Study/German Perinatal Cohort</td><td rowspan="1" colspan="1">Grosch-Worner 2000 [<xref rid="R26" ref-type="bibr">26</xref>]</td><td rowspan="1" colspan="1">1985–1999</td><td rowspan="1" colspan="1">Germany</td><td rowspan="1" colspan="1">Prospective cohort</td><td rowspan="1" colspan="1">179 mother–child pairs</td><td rowspan="1" colspan="1">18–24 months</td><td rowspan="1" colspan="1">Infant HIV transmission</td></tr><tr><td rowspan="1" colspan="1">European Collaborative Study/Italy</td><td rowspan="1" colspan="1">Grignaffini 2000 [<xref rid="R25" ref-type="bibr">25</xref>]</td><td rowspan="1" colspan="1">1987–1999</td><td rowspan="1" colspan="1">Italy</td><td rowspan="1" colspan="1">Prospective cohort</td><td rowspan="1" colspan="1">60 women, 64 children</td><td rowspan="1" colspan="1">18 months</td><td rowspan="1" colspan="1">Infant HIV transmission</td></tr><tr><td rowspan="1" colspan="1">European Collaborative Study/Italian Collaborative Study</td><td rowspan="1" colspan="1">Italian Collaborative Study 1999 [<xref rid="R28" ref-type="bibr">28</xref>]</td><td rowspan="1" colspan="1">1988–1990, 1990–1995</td><td rowspan="1" colspan="1">Italy</td><td rowspan="1" colspan="1">Retrospective cohort (1988–1990), Prospective cohort (1990–1995)</td><td rowspan="1" colspan="1">1040 women</td><td rowspan="1" colspan="1">18 months</td><td rowspan="1" colspan="1">Infant HIV transmission</td></tr><tr><td rowspan="1" colspan="1">European Collaborative Study/Italian Register for HIV Infection in Children</td><td rowspan="1" colspan="1">Galli 2009 [<xref rid="R23" ref-type="bibr">23</xref>]</td><td rowspan="1" colspan="1">2002–2004</td><td rowspan="1" colspan="1">Italy</td><td rowspan="1" colspan="1">Prospective cohort</td><td rowspan="1" colspan="1">937 mother–child pairs</td><td rowspan="1" colspan="1">18 months</td><td rowspan="1" colspan="1">Infant HIV transmission</td></tr><tr><td rowspan="1" colspan="1">European Collaborative Study/Italian Register for HIV Infection in Children</td><td rowspan="1" colspan="1">Galli 2005 [<xref rid="R24" ref-type="bibr">24</xref>]</td><td rowspan="1" colspan="1">1985–1995, 1996–2001</td><td rowspan="1" colspan="1">Italy</td><td rowspan="1" colspan="1">Prospective cohort</td><td rowspan="1" colspan="1">4151 children</td><td rowspan="1" colspan="1">18 months</td><td rowspan="1" colspan="1">Infant HIV transmission</td></tr><tr><td rowspan="1" colspan="1">European Collaborative Study/Italian Register for HIV Infection in Children</td><td rowspan="1" colspan="1">Italian Register for HIV Infection in Children 2002 [<xref rid="R29" ref-type="bibr">29</xref>]</td><td rowspan="1" colspan="1">1985–1995, 1996–1999</td><td rowspan="1" colspan="1">Italy</td><td rowspan="1" colspan="1">Prospective cohort</td><td rowspan="1" colspan="1">3770 children</td><td rowspan="1" colspan="1">18 months</td><td rowspan="1" colspan="1">Infant HIV transmission</td></tr><tr><td rowspan="1" colspan="1">European Mode of Delivery Collaboration (EMDC)</td><td rowspan="1" colspan="1">EMDC 1999 [<xref rid="R21" ref-type="bibr">21</xref>]</td><td rowspan="1" colspan="1">1993–1998</td><td rowspan="1" colspan="1">Italy, France, Spain</td><td rowspan="1" colspan="1">Randomized controlled trial</td><td rowspan="1" colspan="1">436 women</td><td rowspan="1" colspan="1">18 months</td><td rowspan="1" colspan="1">Infant HIV transmission, Maternal morbidities</td></tr><tr><td rowspan="1" colspan="1">European Mode of Delivery Collaboration</td><td rowspan="1" colspan="1">Ricci 2000 [<xref rid="R42" ref-type="bibr">42</xref>]</td><td rowspan="1" colspan="1">1993–1998</td><td rowspan="1" colspan="1">Italy, France, Spain</td><td rowspan="1" colspan="1">Randomized controlled trial</td><td rowspan="1" colspan="1">414 women</td><td rowspan="1" colspan="1">18 months</td><td rowspan="1" colspan="1">Infant HIV transmission, Maternal morbidities</td></tr><tr><td rowspan="1" colspan="1">French Perinatal Cohort</td><td rowspan="1" colspan="1">Briand 2013 [<xref rid="R17" ref-type="bibr">17</xref>]</td><td rowspan="1" colspan="1">2000–2010</td><td rowspan="1" colspan="1">France</td><td rowspan="1" colspan="1">Prospective cohort</td><td rowspan="1" colspan="1">8977 women</td><td rowspan="1" colspan="1">18 months</td><td rowspan="1" colspan="1">Infant HIV transmission, Maternal morbidities</td></tr><tr><td rowspan="1" colspan="1">French Perinatal Cohort</td><td rowspan="1" colspan="1">Marcollet 2002 [<xref rid="R36" ref-type="bibr">36</xref>]</td><td rowspan="1" colspan="1">1989–1999</td><td rowspan="1" colspan="1">France</td><td rowspan="1" colspan="1">Retrospective chart review</td><td rowspan="1" colspan="1">401 women</td><td rowspan="1" colspan="1">6 weeks</td><td rowspan="1" colspan="1">Maternal morbidities</td></tr><tr><td rowspan="1" colspan="1">French Perinatal Cohort</td><td rowspan="1" colspan="1">Mandelbrot 1998 [<xref rid="R35" ref-type="bibr">35</xref>]</td><td rowspan="1" colspan="1">1985–1996</td><td rowspan="1" colspan="1">France</td><td rowspan="1" colspan="1">Prospective cohort</td><td rowspan="1" colspan="1">2834 mother–child pairs</td><td rowspan="1" colspan="1">18 months</td><td rowspan="1" colspan="1">Infant HIV transmission</td></tr><tr><td rowspan="1" colspan="1">French Perinatal Cohort</td><td rowspan="1" colspan="1">Mandelbrot 2013 [<xref rid="R34" ref-type="bibr">34</xref>]</td><td rowspan="1" colspan="1">2005–2010</td><td rowspan="1" colspan="1">France</td><td rowspan="1" colspan="1">Prospective cohort</td><td rowspan="1" colspan="1">4654 women</td><td rowspan="1" colspan="1">18 months</td><td rowspan="1" colspan="1">Infant HIV transmission</td></tr><tr><td rowspan="1" colspan="1">IMPAACT Protocol 1025 Study</td><td rowspan="1" colspan="1">Livingston 2010 [<xref rid="R33" ref-type="bibr">33</xref>]</td><td rowspan="1" colspan="1">2002–2008</td><td rowspan="1" colspan="1">United States, Puerto Rico</td><td rowspan="1" colspan="1">Prospective cohort</td><td rowspan="1" colspan="1">1194 mother–child pairs</td><td rowspan="1" colspan="1">6 months</td><td rowspan="1" colspan="1">Infant HIV transmission, Infant health</td></tr><tr><td rowspan="1" colspan="1">Italian Group of the Gynecological and Obstetrics Society</td><td rowspan="1" colspan="1">Tibaldi 1994 [<xref rid="R46" ref-type="bibr">46</xref>]</td><td rowspan="1" colspan="1">1987–1991</td><td rowspan="1" colspan="1">Italy</td><td rowspan="1" colspan="1">Prospective cohort</td><td rowspan="1" colspan="1">519 mothers, 528 children</td><td rowspan="1" colspan="1">18 months</td><td rowspan="1" colspan="1">Infant HIV transmission</td></tr><tr><td rowspan="1" colspan="1">National Study of HIV in Pregnancy and Childhood</td><td rowspan="1" colspan="1">Townsend 2014 [<xref rid="R47" ref-type="bibr">47</xref>]</td><td rowspan="1" colspan="1">2000–2011</td><td rowspan="1" colspan="1">UK, Ireland</td><td rowspan="1" colspan="1">Population surveillance</td><td rowspan="1" colspan="1">12486 mother–child pairs</td><td rowspan="1" colspan="1">18 months</td><td rowspan="1" colspan="1">Infant HIV transmission</td></tr><tr><td rowspan="1" colspan="1">NISDI Perinatal Study</td><td rowspan="1" colspan="1">Duarte 2006 [<xref rid="R19" ref-type="bibr">19</xref>]</td><td rowspan="1" colspan="1">2002–2005</td><td rowspan="1" colspan="1">Argentina, Bahamas, Brazil, Mexico</td><td rowspan="1" colspan="1">Prospective cohort</td><td rowspan="1" colspan="1">697 women</td><td rowspan="1" colspan="1">6–12 weeks</td><td rowspan="1" colspan="1">Maternal morbidities</td></tr><tr><td rowspan="1" colspan="1">NISDI Perinatal/LILAC Studies</td><td rowspan="1" colspan="1">Kreitchmann 2011 [<xref rid="R32" ref-type="bibr">32</xref>]</td><td rowspan="1" colspan="1">2002–2009</td><td rowspan="1" colspan="1">Argentina, Bahamas, Brazil, Jamaica, Mexico, Peru</td><td rowspan="1" colspan="1">Prospective cohort</td><td rowspan="1" colspan="1">1443 mother–child pairs</td><td rowspan="1" colspan="1">3 years</td><td rowspan="1" colspan="1">Infant health</td></tr><tr><td rowspan="1" colspan="1">Pediatric AIDS Clinical Trials Group Protocol 185</td><td rowspan="1" colspan="1">Watts 2000 [<xref rid="R49" ref-type="bibr">49</xref>]</td><td rowspan="1" colspan="1">1993–1997</td><td rowspan="1" colspan="1">United States</td><td rowspan="1" colspan="1">Prospective cohort</td><td rowspan="1" colspan="1">501 women</td><td rowspan="1" colspan="1">18 months</td><td rowspan="1" colspan="1">Maternal morbidities</td></tr><tr><td rowspan="1" colspan="1">Pilot PMTCT Programme</td><td rowspan="1" colspan="1">Cocu 2005 [<xref rid="R18" ref-type="bibr">18</xref>]</td><td rowspan="1" colspan="1">2000–2002</td><td rowspan="1" colspan="1">Romania</td><td rowspan="1" colspan="1">Prospective cohort</td><td rowspan="1" colspan="1">20 women</td><td rowspan="1" colspan="1">6 weeks, 3 months, 18 months</td><td rowspan="1" colspan="1">Infant HIV transmission</td></tr><tr><td rowspan="1" colspan="1">Swiss Neonatal HIV Study Group</td><td rowspan="1" colspan="1">Kind 1995 [<xref rid="R30" ref-type="bibr">30</xref>]</td><td rowspan="1" colspan="1">1986–1993</td><td rowspan="1" colspan="1">Switzerland</td><td rowspan="1" colspan="1">Prospective cohort</td><td rowspan="1" colspan="1">316 children</td><td rowspan="1" colspan="1">24 months</td><td rowspan="1" colspan="1">Infant HIV transmission</td></tr><tr><td rowspan="1" colspan="1">Swiss Neonatal HIV Study Group</td><td rowspan="1" colspan="1">Kind 1998 [<xref rid="R31" ref-type="bibr">31</xref>]</td><td rowspan="1" colspan="1">1986–1996</td><td rowspan="1" colspan="1">Switzerland</td><td rowspan="1" colspan="1">Prospective cohort</td><td rowspan="1" colspan="1">496 children</td><td rowspan="1" colspan="1">24 months</td><td rowspan="1" colspan="1">Infant HIV transmission</td></tr><tr><td rowspan="1" colspan="1">Women and Infants Transmission Study</td><td rowspan="1" colspan="1">Navas-Nacher 2006 [<xref rid="R38" ref-type="bibr">38</xref>]</td><td rowspan="1" colspan="1">1990–2004</td><td rowspan="1" colspan="1">United States, Puerto Rico</td><td rowspan="1" colspan="1">Prospective cohort</td><td rowspan="1" colspan="1">1491 deliveries</td><td rowspan="1" colspan="1">2 months, 6 months, 12 months, 18 months</td><td rowspan="1" colspan="1">Maternal morbidities</td></tr><tr><td rowspan="1" colspan="1">Women and Infants Transmission Study</td><td rowspan="1" colspan="1">Read 2001 [<xref rid="R41" ref-type="bibr">41</xref>]</td><td rowspan="1" colspan="1">1989–1998</td><td rowspan="1" colspan="1">United States, Puerto Rico</td><td rowspan="1" colspan="1">Prospective cohort</td><td rowspan="1" colspan="1">1186 deliveries</td><td rowspan="1" colspan="1">2 months</td><td rowspan="1" colspan="1">Maternal morbidities</td></tr><tr><td rowspan="1" colspan="1">–</td><td rowspan="1" colspan="1">Bobat 1996 [<xref rid="R15" ref-type="bibr">15</xref>]</td><td rowspan="1" colspan="1">1990–1993</td><td rowspan="1" colspan="1">South Africa</td><td rowspan="1" colspan="1">Prospective cohort</td><td rowspan="1" colspan="1">229 women, 234 children</td><td rowspan="1" colspan="1">15 months</td><td rowspan="1" colspan="1">Infant HIV transmission</td></tr><tr><td rowspan="1" colspan="1">–</td><td rowspan="1" colspan="1">Iloh 2015 [<xref rid="R27" ref-type="bibr">27</xref>]</td><td rowspan="1" colspan="1">2011–2012</td><td rowspan="1" colspan="1">Nigeria</td><td rowspan="1" colspan="1">Prospective cohort</td><td rowspan="1" colspan="1">210 children</td><td rowspan="1" colspan="1">18 months</td><td rowspan="1" colspan="1">Infant HIV transmission</td></tr><tr><td rowspan="1" colspan="1">–</td><td rowspan="1" colspan="1">Mukherjee 2010 [<xref rid="R37" ref-type="bibr">37</xref>]</td><td rowspan="1" colspan="1">2001–2005</td><td rowspan="1" colspan="1">India</td><td rowspan="1" colspan="1">Retrospective cohort</td><td rowspan="1" colspan="1">362 women</td><td rowspan="1" colspan="1">1 month</td><td rowspan="1" colspan="1">Infant HIV transmission</td></tr><tr><td rowspan="1" colspan="1">–</td><td rowspan="1" colspan="1">Shah 2006 [<xref rid="R43" ref-type="bibr">43</xref>]</td><td rowspan="1" colspan="1">2000–2003</td><td rowspan="1" colspan="1">India</td><td rowspan="1" colspan="1">Retrospective cohort</td><td rowspan="1" colspan="1">470 mother–child pairs</td><td rowspan="1" colspan="1">18 months</td><td rowspan="1" colspan="1">Infant HIV transmission</td></tr><tr><td rowspan="1" colspan="1">–</td><td rowspan="1" colspan="1">Succi 2007 [<xref rid="R44" ref-type="bibr">44</xref>]</td><td rowspan="1" colspan="1">2000, 2001</td><td rowspan="1" colspan="1">Brazil</td><td rowspan="1" colspan="1">Cross-sectional (retrospective chart review)</td><td rowspan="1" colspan="1">2924 children</td><td rowspan="1" colspan="1">15 months</td><td rowspan="1" colspan="1">Infant HIV transmission</td></tr><tr><td rowspan="1" colspan="1">–</td><td rowspan="1" colspan="1">Unger 2014 [<xref rid="R48" ref-type="bibr">48</xref>]</td><td rowspan="1" colspan="1">2000–2005</td><td rowspan="1" colspan="1">Kenya</td><td rowspan="1" colspan="1">Prospective cohort</td><td rowspan="1" colspan="1">501 women</td><td rowspan="1" colspan="1">12 months</td><td rowspan="1" colspan="1">Maternal mortality</td></tr></tbody></table></table-wrap><p>One study (reported in two articles) was an RCT: the European Mode of Delivery Collaboration [<xref rid="R21" ref-type="bibr">21</xref>,<xref rid="R42" ref-type="bibr">42</xref>]. The RCT was not blinded (due to the impossibility of blinding mode of delivery), but had limited attrition and received low risk of bias judgments across measures on the Cochrane Risk of Bias tool (see Supplementary Appendix, <ext-link ext-link-type="uri" xlink:href="http://links.lww.com/QAD/B103">http://links.lww.com/QAD/B103</ext-link>). The remaining studies were observational designs, mostly prospective cohort studies that followed infants after delivery to assess infant HIV infection outcomes. Follow-up periods ranged from 1 month to 3 years; 27 of the 36 included articles had follow-up periods of 18 months or longer.</p><p>Results are presented below for each of the main outcomes. Funnel plots did not indicate publication bias. Heterogeneity was not substantially significant in most meta-analyses.</p></sec><sec><title>Maternal health outcomes</title><p>Maternal health outcomes are reported in Table <xref ref-type="table" rid="T2">2</xref>. In the RCT, adverse maternal health outcomes were minimal [<xref rid="R21" ref-type="bibr">21</xref>,<xref rid="R42" ref-type="bibr">42</xref>]. Postpartum fever was reported by 1.1% (2/183) of women who gave birth vaginally and 6.7% (15/225) who gave birth by ECS (<italic>P</italic> = 0.002). Postpartum bleeding or intravascular coagulation disease occurred in one woman in each group. Anemia of greater than moderate severity (hemoglobin < 8 g/dl) was reported in two women who gave birth vaginally and four by ECS. No further adverse events were reported at 6-week follow-up.</p><table-wrap id="T2" position="float"><label>Table 2</label><caption><p>Meta-analytic results for maternal health outcomes, comparing modes of delivery.</p></caption><table frame="hsides" rules="groups"><thead><tr><td rowspan="1" colspan="1"></td><td colspan="5" rowspan="1">ECS versus vaginal delivery</td><td colspan="5" rowspan="1">ECS versus all other modes of delivery</td></tr><tr><td rowspan="1" colspan="1"></td><td rowspan="1" colspan="1">No. of articles</td><td rowspan="1" colspan="1">No. of effect sizes</td><td rowspan="1" colspan="1">No. of participants</td><td rowspan="1" colspan="1">OR (95% CI)</td><td rowspan="1" colspan="1"><italic>I</italic><sup>2</sup></td><td rowspan="1" colspan="1">No. of articles</td><td rowspan="1" colspan="1">No. of effect sizes</td><td rowspan="1" colspan="1">No. of participants</td><td rowspan="1" colspan="1">OR (95% CI)</td><td rowspan="1" colspan="1"><italic>I</italic><sup>2</sup></td></tr></thead><tbody><tr><td colspan="11" rowspan="1">RCTs</td></tr><tr><td rowspan="1" colspan="1"> Postpartum fever</td><td rowspan="1" colspan="1">1 [<xref rid="R42" ref-type="bibr">42</xref>]</td><td rowspan="1" colspan="1">1</td><td rowspan="1" colspan="1">414</td><td rowspan="1" colspan="1">5.12 (1.48–17.75)<xref ref-type="table-fn" rid="TF2-3"><sup>c</sup></xref></td><td rowspan="1" colspan="1">–</td><td rowspan="1" colspan="1">–</td><td rowspan="1" colspan="1">–</td><td rowspan="1" colspan="1">–</td><td rowspan="1" colspan="1">–</td><td rowspan="1" colspan="1">–</td></tr><tr><td rowspan="1" colspan="1"> Wound infection</td><td rowspan="1" colspan="1">1 [<xref rid="R42" ref-type="bibr">42</xref>]</td><td rowspan="1" colspan="1">1</td><td rowspan="1" colspan="1">414</td><td rowspan="1" colspan="1">1.71 (0.31–9.44)<xref ref-type="table-fn" rid="TF2-3"><sup>c</sup></xref></td><td rowspan="1" colspan="1">–</td><td rowspan="1" colspan="1">–</td><td rowspan="1" colspan="1">–</td><td rowspan="1" colspan="1">–</td><td rowspan="1" colspan="1">–</td><td rowspan="1" colspan="1">–</td></tr><tr><td rowspan="1" colspan="1"> Anesthetic</td><td rowspan="1" colspan="1">1 [<xref rid="R42" ref-type="bibr">42</xref>]</td><td rowspan="1" colspan="1">1</td><td rowspan="1" colspan="1">414</td><td rowspan="1" colspan="1">4.28 (0.20–89.72)<xref ref-type="table-fn" rid="TF2-3"><sup>c</sup></xref></td><td rowspan="1" colspan="1">–</td><td rowspan="1" colspan="1">–</td><td rowspan="1" colspan="1">–</td><td rowspan="1" colspan="1">–</td><td rowspan="1" colspan="1">–</td><td rowspan="1" colspan="1">–</td></tr><tr><td rowspan="1" colspan="1"> Anemia</td><td rowspan="1" colspan="1">1 [<xref rid="R42" ref-type="bibr">42</xref>]</td><td rowspan="1" colspan="1">1</td><td rowspan="1" colspan="1">414</td><td rowspan="1" colspan="1">3.03 (0.62–14.77)<xref ref-type="table-fn" rid="TF2-3"><sup>c</sup></xref></td><td rowspan="1" colspan="1">–</td><td rowspan="1" colspan="1">–</td><td rowspan="1" colspan="1">–</td><td rowspan="1" colspan="1">–</td><td rowspan="1" colspan="1">–</td><td rowspan="1" colspan="1">–</td></tr><tr><td rowspan="1" colspan="1"> Other complications</td><td rowspan="1" colspan="1">1 [<xref rid="R42" ref-type="bibr">42</xref>]</td><td rowspan="1" colspan="1">1</td><td rowspan="1" colspan="1">414</td><td rowspan="1" colspan="1">0.63 (0.14–2.85)<xref ref-type="table-fn" rid="TF2-3"><sup>c</sup></xref></td><td rowspan="1" colspan="1">–</td><td rowspan="1" colspan="1">–</td><td rowspan="1" colspan="1">–</td><td rowspan="1" colspan="1">–</td><td rowspan="1" colspan="1">–</td><td rowspan="1" colspan="1">–</td></tr><tr><td colspan="11" rowspan="1">Observational studies</td></tr><tr><td rowspan="1" colspan="1"> Mortality in the first year postpartum</td><td rowspan="1" colspan="1">1 [<xref rid="R48" ref-type="bibr">48</xref>]</td><td rowspan="1" colspan="1">0<xref ref-type="table-fn" rid="TF2-4"><sup>d</sup></xref></td><td rowspan="1" colspan="1">427</td><td rowspan="1" colspan="1">–</td><td rowspan="1" colspan="1">–</td><td rowspan="1" colspan="1">1</td><td rowspan="1" colspan="1">0<xref ref-type="table-fn" rid="TF2-3"><sup>c</sup></xref></td><td rowspan="1" colspan="1">501</td><td rowspan="1" colspan="1">–</td><td rowspan="1" colspan="1">–</td></tr><tr><td rowspan="1" colspan="1"> All morbidities<xref ref-type="table-fn" rid="TF2-2"><sup>b</sup></xref></td><td rowspan="1" colspan="1">6 [<xref rid="R17" ref-type="bibr">17</xref>,<xref rid="R19" ref-type="bibr">19</xref>,<xref rid="R22" ref-type="bibr">22</xref>,<xref rid="R36" ref-type="bibr">36</xref>,<xref rid="R38" ref-type="bibr">38</xref>,<xref rid="R49" ref-type="bibr">49</xref>]</td><td rowspan="1" colspan="1">7</td><td rowspan="1" colspan="1">7821</td><td rowspan="1" colspan="1">3.12 (2.21–4.41)</td><td rowspan="1" colspan="1">58.14</td><td rowspan="1" colspan="1">5 [<xref rid="R17" ref-type="bibr">17</xref>,<xref rid="R19" ref-type="bibr">19</xref>,<xref rid="R36" ref-type="bibr">36</xref>,<xref rid="R38" ref-type="bibr">38</xref>,<xref rid="R49" ref-type="bibr">49</xref>]</td><td rowspan="1" colspan="1">5</td><td rowspan="1" colspan="1">7893</td><td rowspan="1" colspan="1">1.52 (1.06–2.20)</td><td rowspan="1" colspan="1">65.29</td></tr><tr><td rowspan="1" colspan="1"> All morbidities, LMICs only<xref ref-type="table-fn" rid="TF2-1"><sup>a</sup></xref></td><td rowspan="1" colspan="1">1 [<xref rid="R19" ref-type="bibr">19</xref>]</td><td rowspan="1" colspan="1">1</td><td rowspan="1" colspan="1">559</td><td rowspan="1" colspan="1">1.16 (0.49–2.71)</td><td rowspan="1" colspan="1">N/A<xref ref-type="table-fn" rid="TF2-5"><sup>e</sup></xref></td><td rowspan="1" colspan="1">1 [<xref rid="R19" ref-type="bibr">19</xref>]</td><td rowspan="1" colspan="1">1</td><td rowspan="1" colspan="1">697</td><td rowspan="1" colspan="1">0.73 (0.35–1.51)</td><td rowspan="1" colspan="1">N/A<xref ref-type="table-fn" rid="TF2-5"><sup>e</sup></xref></td></tr><tr><td rowspan="1" colspan="1"> UTI or febrile UTI</td><td rowspan="1" colspan="1">6 [<xref rid="R17" ref-type="bibr">17</xref>,<xref rid="R19" ref-type="bibr">19</xref>,<xref rid="R22" ref-type="bibr">22</xref>,<xref rid="R36" ref-type="bibr">36</xref>,<xref rid="R41" ref-type="bibr">41</xref>,<xref rid="R49" ref-type="bibr">49</xref>]</td><td rowspan="1" colspan="1">7</td><td rowspan="1" colspan="1">5683</td><td rowspan="1" colspan="1">1.85 (1.18–2.88)</td><td rowspan="1" colspan="1">0</td><td rowspan="1" colspan="1">5 [<xref rid="R17" ref-type="bibr">17</xref>,<xref rid="R19" ref-type="bibr">19</xref>,<xref rid="R36" ref-type="bibr">36</xref>,<xref rid="R41" ref-type="bibr">41</xref>,<xref rid="R49" ref-type="bibr">49</xref>]</td><td rowspan="1" colspan="1">6</td><td rowspan="1" colspan="1">6672</td><td rowspan="1" colspan="1">1.18 (0.80–1.76)</td><td rowspan="1" colspan="1">0</td></tr><tr><td rowspan="1" colspan="1"> UTI or febrile UTI, LMICs only<xref ref-type="table-fn" rid="TF2-1"><sup>a</sup></xref></td><td rowspan="1" colspan="1">1 [<xref rid="R19" ref-type="bibr">19</xref>]</td><td rowspan="1" colspan="1">1</td><td rowspan="1" colspan="1">559</td><td rowspan="1" colspan="1">1.57 (0.84–2.92)</td><td rowspan="1" colspan="1">N/A<xref ref-type="table-fn" rid="TF2-5"><sup>e</sup></xref></td><td rowspan="1" colspan="1">1 [<xref rid="R19" ref-type="bibr">19</xref>]</td><td rowspan="1" colspan="1">1</td><td rowspan="1" colspan="1">697</td><td rowspan="1" colspan="1">1.06 (0.62–1.79)</td><td rowspan="1" colspan="1">N/A<xref ref-type="table-fn" rid="TF2-5"><sup>e</sup></xref></td></tr><tr><td rowspan="1" colspan="1"> Endometritis, febrile endometritis, or amnionitis</td><td rowspan="1" colspan="1">5 [<xref rid="R17" ref-type="bibr">17</xref>,<xref rid="R22" ref-type="bibr">22</xref>,<xref rid="R36" ref-type="bibr">36</xref>,<xref rid="R41" ref-type="bibr">41</xref>,<xref rid="R49" ref-type="bibr">49</xref>]</td><td rowspan="1" colspan="1">5</td><td rowspan="1" colspan="1">5124</td><td rowspan="1" colspan="1">1.53 (0.68–3.44)</td><td rowspan="1" colspan="1">40.62</td><td rowspan="1" colspan="1">4 [<xref rid="R17" ref-type="bibr">17</xref>,<xref rid="R36" ref-type="bibr">36</xref>,<xref rid="R41" ref-type="bibr">41</xref>,<xref rid="R49" ref-type="bibr">49</xref>]</td><td rowspan="1" colspan="1">4</td><td rowspan="1" colspan="1">5975</td><td rowspan="1" colspan="1">1.17 (0.65–2.12)</td><td rowspan="1" colspan="1">0</td></tr><tr><td rowspan="1" colspan="1"> Hemorrhage, transfusion, or severe anemia</td><td rowspan="1" colspan="1">5 [<xref rid="R17" ref-type="bibr">17</xref>,<xref rid="R22" ref-type="bibr">22</xref>,<xref rid="R36" ref-type="bibr">36</xref>,<xref rid="R41" ref-type="bibr">41</xref>,<xref rid="R49" ref-type="bibr">49</xref>]</td><td rowspan="1" colspan="1">7</td><td rowspan="1" colspan="1">5433</td><td rowspan="1" colspan="1">1.91 (1.20–3.03)</td><td rowspan="1" colspan="1">3.14</td><td rowspan="1" colspan="1">4 [<xref rid="R17" ref-type="bibr">17</xref>,<xref rid="R36" ref-type="bibr">36</xref>,<xref rid="R41" ref-type="bibr">41</xref>,<xref rid="R49" ref-type="bibr">49</xref>]</td><td rowspan="1" colspan="1">6</td><td rowspan="1" colspan="1">5975</td><td rowspan="1" colspan="1">1.83 (1.07–3.1)</td><td rowspan="1" colspan="1">20.76</td></tr></tbody></table><table-wrap-foot><fn fn-type="other"><p>CI, confidence interval; ECS, elective c-section; LMIC, low-income/middle-income countries; OR, odds ratio; RCT, randomized controlled trial; UTI, urinary tract infection.</p></fn><fn fn-type="other" id="TF2-1"><p><sup>a</sup>Included studies were conducted in countries classified as lower income, lower-middle, or upper-middle income by the World Bank.</p></fn><fn fn-type="other" id="TF2-2"><p><sup>b</sup>All morbidities refers to any major or minor postpartum complication, including abscess, amnionitis, anemia, anesthesia complications, cystitis, deep vein thrombosis, diffuse intravascular dissemination, endometritis, fever, hematoma, hemorrhage, peritonitis, pneumonia, pneumopathy, postpartum operation, pyelonephritis, sepsis, septic pelvic thrombophletitis, septic shock syndrome, subileus, transfusion (red blood cell/platelet), UTI, wound (caesarean incision or episiotomy) infection or dehiscence.</p></fn><fn fn-type="other" id="TF2-3"><p><sup>c</sup>OR and 95% CI were not reported in the text; these statistics were calculated from data presented in tables.</p></fn><fn fn-type="other" id="TF2-4"><p><sup>d</sup>One study presented maternal mortality outcomes. ORs were not calculable given the lack of events in the ECS group. Eight deaths were reported of the 405 women delivering vaginally, five of the 74 given non-ECS, and none of the 22 given ECS.</p></fn><fn fn-type="other" id="TF2-5"><p><sup>e</sup>Not applicable, as meta-analysis was not conducted when there was only a single effect size.</p></fn></table-wrap-foot></table-wrap><p>One observational study in Kenya examined maternal mortality [<xref rid="R48" ref-type="bibr">48</xref>]. Eight deaths were reported of the 405 women delivering vaginally, five of the 74 given non-ECS, and none of the 22 given ECS [<xref rid="R48" ref-type="bibr">48</xref>].</p><p>Six observational studies measured overall maternal morbidity (all morbidities combined) [<xref rid="R17" ref-type="bibr">17</xref>,<xref rid="R19" ref-type="bibr">19</xref>,<xref rid="R22" ref-type="bibr">22</xref>,<xref rid="R36" ref-type="bibr">36</xref>,<xref rid="R38" ref-type="bibr">38</xref>,<xref rid="R49" ref-type="bibr">49</xref>]. In meta-analysis, ECS was associated with increased odds of all morbidities compared with vaginal delivery (OR 3.12, 95% CI 2.21–4.41) but the OR was lower when compared with all other modes of delivery (OR 1.52, 95% CI 1.06–2.20) [<xref rid="R17" ref-type="bibr">17</xref>,<xref rid="R19" ref-type="bibr">19</xref>,<xref rid="R36" ref-type="bibr">36</xref>,<xref rid="R38" ref-type="bibr">38</xref>,<xref rid="R49" ref-type="bibr">49</xref>]. Both meta-analyses demonstrated substantial heterogeneity. Just one of these studies came from LMICs [<xref rid="R19" ref-type="bibr">19</xref>]: this multisite study conducted in four Latin American and Caribbean countries found no statistically significant difference in overall maternal morbidity with ECS compared with either vaginal (OR 1.16, 95% CI 0.49–2.71) or all other modes of delivery (OR 0.73, 95% CI 0.35–1.51).</p><p>Combining studies measuring UTIs and febrile UTIs, ECS was associated with increased odds of UTIs compared with vaginal delivery (OR 1.85, 95% CI 1.18–2.88) [<xref rid="R17" ref-type="bibr">17</xref>,<xref rid="R19" ref-type="bibr">19</xref>,<xref rid="R22" ref-type="bibr">22</xref>,<xref rid="R36" ref-type="bibr">36</xref>,<xref rid="R41" ref-type="bibr">41</xref>,<xref rid="R49" ref-type="bibr">49</xref>] but not when compared with all other modes (OR 1.18, 95% CI 0.80–1.76) [<xref rid="R17" ref-type="bibr">17</xref>,<xref rid="R19" ref-type="bibr">19</xref>,<xref rid="R36" ref-type="bibr">36</xref>,<xref rid="R41" ref-type="bibr">41</xref>,<xref rid="R49" ref-type="bibr">49</xref>]. The odds of endometritis, febrile endometritis, and/or amnionitis among women who had ECS was not significantly different from the odds among those with vaginal delivery (OR 1.53, 95% CI 0.68–3.44) [<xref rid="R17" ref-type="bibr">17</xref>,<xref rid="R22" ref-type="bibr">22</xref>,<xref rid="R36" ref-type="bibr">36</xref>,<xref rid="R41" ref-type="bibr">41</xref>,<xref rid="R49" ref-type="bibr">49</xref>] or all other modes (OR 1.17, 95% CI 0.65–2.12) [<xref rid="R17" ref-type="bibr">17</xref>,<xref rid="R36" ref-type="bibr">36</xref>,<xref rid="R41" ref-type="bibr">41</xref>,<xref rid="R49" ref-type="bibr">49</xref>]. Women who had ECS were more likely to have hemorrhage, transfusion, and/or severe anemia compared with women who had vaginal deliveries (OR 1.91, 95% CI 1.2–3.03) [<xref rid="R17" ref-type="bibr">17</xref>,<xref rid="R22" ref-type="bibr">22</xref>,<xref rid="R36" ref-type="bibr">36</xref>,<xref rid="R41" ref-type="bibr">41</xref>,<xref rid="R49" ref-type="bibr">49</xref>] or all other modes (OR 1.83, 95% CI 1.07–3.1) [<xref rid="R17" ref-type="bibr">17</xref>,<xref rid="R36" ref-type="bibr">36</xref>,<xref rid="R41" ref-type="bibr">41</xref>,<xref rid="R49" ref-type="bibr">49</xref>].</p></sec><sec><title>Infant HIV infection</title><p>By far, the most common outcome measured was infant HIV infection (Table <xref ref-type="table" rid="T3">3</xref>). The RCT found significantly fewer HIV infections among infants delivered by ECS (1.7%) versus vaginal delivery (10.6%) (OR 0.2, 95% CI 0.0–0.5) [<xref rid="R42" ref-type="bibr">42</xref>]. The OR was closer to one and nonsignificant for women who received zidovudine in pregnancy (OR 0.4, 95% CI 0–1.4) compared with the OR for women who received no zidovudine in pregnancy (OR 0.2, 95% CI 0–0.8).</p><table-wrap id="T3" position="float"><label>Table 3</label><caption><p>Meta-analytic results for infant HIV infection, comparing modes of delivery across study types and subpopulations.</p></caption><table frame="hsides" rules="groups"><thead><tr><td rowspan="1" colspan="1"></td><td colspan="5" rowspan="1">ECS versus vaginal delivery</td><td colspan="5" rowspan="1">ECS versus all other modes of delivery</td></tr><tr><td rowspan="1" colspan="1"></td><td rowspan="1" colspan="1">No. of articles</td><td rowspan="1" colspan="1">No. of effect sizes</td><td rowspan="1" colspan="1">No. of participants</td><td rowspan="1" colspan="1">OR (95% CI)</td><td rowspan="1" colspan="1"><italic>I</italic><sup>2</sup></td><td rowspan="1" colspan="1">No. of articles</td><td rowspan="1" colspan="1">No. of effect sizes</td><td rowspan="1" colspan="1">No. of participants</td><td rowspan="1" colspan="1">OR (95% CI)</td><td rowspan="1" colspan="1"><italic>I</italic><sup>2</sup></td></tr></thead><tbody><tr><td rowspan="1" colspan="1">RCTs</td><td rowspan="1" colspan="1">1 [<xref rid="R42" ref-type="bibr">42</xref>]</td><td rowspan="1" colspan="1">1</td><td rowspan="1" colspan="1">385</td><td rowspan="1" colspan="1">0.2 (0.0–0.5)</td><td rowspan="1" colspan="1">N/A<xref ref-type="table-fn" rid="TF3-3"><sup>c</sup></xref></td><td rowspan="1" colspan="1">–</td><td rowspan="1" colspan="1">–</td><td rowspan="1" colspan="1"></td><td rowspan="1" colspan="1">–</td><td rowspan="1" colspan="1">–</td></tr><tr><td rowspan="1" colspan="1">Observational studies</td><td rowspan="1" colspan="1">13 [<xref rid="R15" ref-type="bibr">15</xref>–<xref rid="R18" ref-type="bibr">18</xref>,<xref rid="R27" ref-type="bibr">27</xref>,<xref rid="R31" ref-type="bibr">31</xref>,<xref rid="R33" ref-type="bibr">33</xref>,<xref rid="R35" ref-type="bibr">35</xref>,<xref rid="R37" ref-type="bibr">37</xref>,<xref rid="R43" ref-type="bibr">43</xref>,<xref rid="R44" ref-type="bibr">44</xref>,<xref rid="R46" ref-type="bibr">46</xref>,<xref rid="R47" ref-type="bibr">47</xref>]</td><td rowspan="1" colspan="1">24</td><td rowspan="1" colspan="1">16204</td><td rowspan="1" colspan="1">0.43 (0.30–0.63)</td><td rowspan="1" colspan="1">40.67</td><td rowspan="1" colspan="1">9 [<xref rid="R15" ref-type="bibr">15</xref>–<xref rid="R17" ref-type="bibr">17</xref>,<xref rid="R27" ref-type="bibr">27</xref>,<xref rid="R31" ref-type="bibr">31</xref>,<xref rid="R33" ref-type="bibr">33</xref>,<xref rid="R44" ref-type="bibr">44</xref>,<xref rid="R46" ref-type="bibr">46</xref>,<xref rid="R47" ref-type="bibr">47</xref>]</td><td rowspan="1" colspan="1">19</td><td rowspan="1" colspan="1">17638</td><td rowspan="1" colspan="1">0.47 (0.33–0.67)</td><td rowspan="1" colspan="1">31.26</td></tr><tr><td rowspan="1" colspan="1">Studies during the cART era<xref ref-type="table-fn" rid="TF3-1"><sup>a</sup></xref></td><td rowspan="1" colspan="1">9 [<xref rid="R17" ref-type="bibr">17</xref>,<xref rid="R18" ref-type="bibr">18</xref>,<xref rid="R20" ref-type="bibr">20</xref>,<xref rid="R26" ref-type="bibr">26</xref>,<xref rid="R32" ref-type="bibr">32</xref>,<xref rid="R35" ref-type="bibr">35</xref>,<xref rid="R36" ref-type="bibr">36</xref>,<xref rid="R41" ref-type="bibr">41</xref>,<xref rid="R45" ref-type="bibr">45</xref>]</td><td rowspan="1" colspan="1">19</td><td rowspan="1" colspan="1">13719</td><td rowspan="1" colspan="1">0.45 (0.30–0.67)</td><td rowspan="1" colspan="1">21.89</td><td rowspan="1" colspan="1">5 [<xref rid="R17" ref-type="bibr">17</xref>,<xref rid="R26" ref-type="bibr">26</xref>,<xref rid="R32" ref-type="bibr">32</xref>,<xref rid="R35" ref-type="bibr">35</xref>,<xref rid="R45" ref-type="bibr">45</xref>]</td><td rowspan="1" colspan="1">15</td><td rowspan="1" colspan="1">15724</td><td rowspan="1" colspan="1">0.59 (0.37–0.93)</td><td rowspan="1" colspan="1">34.82</td></tr><tr><td rowspan="1" colspan="1">cART patients only</td><td rowspan="1" colspan="1">4 [<xref rid="R17" ref-type="bibr">17</xref>,<xref rid="R18" ref-type="bibr">18</xref>,<xref rid="R33" ref-type="bibr">33</xref>,<xref rid="R47" ref-type="bibr">47</xref>]</td><td rowspan="1" colspan="1">13</td><td rowspan="1" colspan="1">8823</td><td rowspan="1" colspan="1">0.82 (0.47–1.43)</td><td rowspan="1" colspan="1">0</td><td rowspan="1" colspan="1">3 [<xref rid="R17" ref-type="bibr">17</xref>,<xref rid="R18" ref-type="bibr">18</xref>,<xref rid="R33" ref-type="bibr">33</xref>]</td><td rowspan="1" colspan="1">12</td><td rowspan="1" colspan="1">12708</td><td rowspan="1" colspan="1">0.94 (0.59–1.51)</td><td rowspan="1" colspan="1">0</td></tr><tr><td rowspan="1" colspan="1">cART patients delivering at term only</td><td rowspan="1" colspan="1">1 [<xref rid="R17" ref-type="bibr">17</xref>]</td><td rowspan="1" colspan="1">5</td><td rowspan="1" colspan="1">3269</td><td rowspan="1" colspan="1">0.26 (0.62–1.45)</td><td rowspan="1" colspan="1">0</td><td rowspan="1" colspan="1">1 [<xref rid="R17" ref-type="bibr">17</xref>]</td><td rowspan="1" colspan="1">5</td><td rowspan="1" colspan="1">5242</td><td rowspan="1" colspan="1">0.72 (0.35–1.46)</td><td rowspan="1" colspan="1">0</td></tr><tr><td rowspan="1" colspan="1">Women with CD4<sup>+</sup> cell count > 200 or VL < 400 only</td><td rowspan="1" colspan="1">2 [<xref rid="R16" ref-type="bibr">16</xref>,<xref rid="R17" ref-type="bibr">17</xref>]</td><td rowspan="1" colspan="1">5</td><td rowspan="1" colspan="1">4022</td><td rowspan="1" colspan="1">0.36 (0.17–0.79)</td><td rowspan="1" colspan="1">10.08</td><td rowspan="1" colspan="1">2 [<xref rid="R16" ref-type="bibr">16</xref>,<xref rid="R17" ref-type="bibr">17</xref>]</td><td rowspan="1" colspan="1">5</td><td rowspan="1" colspan="1">6314</td><td rowspan="1" colspan="1">0.46 (0.24–0.88)</td><td rowspan="1" colspan="1">0</td></tr><tr><td rowspan="1" colspan="1">Women with CD4<sup>+</sup> cell count > 200 or VL < 400 delivering at term only</td><td rowspan="1" colspan="1">1 [<xref rid="R17" ref-type="bibr">17</xref>]</td><td rowspan="1" colspan="1">2</td><td rowspan="1" colspan="1">2782</td><td rowspan="1" colspan="1">0.59 (0.21–1.63)</td><td rowspan="1" colspan="1">0</td><td rowspan="1" colspan="1">1 [<xref rid="R17" ref-type="bibr">17</xref>]</td><td rowspan="1" colspan="1">2</td><td rowspan="1" colspan="1">4644</td><td rowspan="1" colspan="1">0.73 (0.29–1.80)</td><td rowspan="1" colspan="1">0</td></tr><tr><td rowspan="1" colspan="1">LMICs only<xref ref-type="table-fn" rid="TF3-2"><sup>b</sup></xref></td><td rowspan="1" colspan="1">5 [<xref rid="R18" ref-type="bibr">18</xref>,<xref rid="R27" ref-type="bibr">27</xref>,<xref rid="R37" ref-type="bibr">37</xref>,<xref rid="R43" ref-type="bibr">43</xref>,<xref rid="R44" ref-type="bibr">44</xref>]</td><td rowspan="1" colspan="1">6</td><td rowspan="1" colspan="1">2925</td><td rowspan="1" colspan="1">0.27 (0.16–0.45)</td><td rowspan="1" colspan="1">18.56</td><td rowspan="1" colspan="1">2 [<xref rid="R27" ref-type="bibr">27</xref>,<xref rid="R44" ref-type="bibr">44</xref>]</td><td rowspan="1" colspan="1">3</td><td rowspan="1" colspan="1">3016</td><td rowspan="1" colspan="1">0.34 (0.15–0.78)</td><td rowspan="1" colspan="1">67.32</td></tr></tbody></table><table-wrap-foot><fn fn-type="other"><p>cART, combination antiretroviral therapy; CI, confidence interval; ECS, elective c-section; LMIC, low-income/middle-income countries; OR, odds ratio; RCT, randomized controlled trial; VL, viral load.</p></fn><fn fn-type="other" id="TF3-1"><p><sup>a</sup>cART era was considered after 1996 or ART use in country.</p></fn><fn fn-type="other" id="TF3-2"><p><sup>b</sup>Countries classified as lower income, lower-middle, or upper-middle income by the World Bank.</p></fn><fn fn-type="other" id="TF3-3"><p><sup>c</sup>Not applicable, as meta-analysis was not conducted on the single RCT.</p></fn></table-wrap-foot></table-wrap><p>In meta-analysis of all observational studies, ECS was also associated with a decreased odds of infant HIV infection (Table <xref ref-type="table" rid="T3">3</xref>). The OR for infant HIV infection comparing ECS to vaginal delivery was 0.43 (95% CI 0.30–0.63, moderate heterogeneity) [<xref rid="R15" ref-type="bibr">15</xref>–<xref rid="R18" ref-type="bibr">18</xref>,<xref rid="R27" ref-type="bibr">27</xref>,<xref rid="R31" ref-type="bibr">31</xref>,<xref rid="R33" ref-type="bibr">33</xref>,<xref rid="R35" ref-type="bibr">35</xref>,<xref rid="R37" ref-type="bibr">37</xref>,<xref rid="R43" ref-type="bibr">43</xref>,<xref rid="R44" ref-type="bibr">44</xref>,<xref rid="R46" ref-type="bibr">46</xref>,<xref rid="R47" ref-type="bibr">47</xref>] and 0.47 (95% CI 0.33–0.67, moderate heterogeneity) when comparing to all other modes of delivery [<xref rid="R15" ref-type="bibr">15</xref>–<xref rid="R17" ref-type="bibr">17</xref>,<xref rid="R27" ref-type="bibr">27</xref>,<xref rid="R31" ref-type="bibr">31</xref>,<xref rid="R33" ref-type="bibr">33</xref>,<xref rid="R44" ref-type="bibr">44</xref>,<xref rid="R46" ref-type="bibr">46</xref>,<xref rid="R47" ref-type="bibr">47</xref>]. For studies conducted during the cART era, ECS continued its association with decreased odds of infant HIV infection.</p><p>Stratifying to patients receiving cART, the relationship between ECS and lower infant HIV infection was no longer statistically significant (OR 0.82, 95% CI 0.47–1.43 versus vaginal delivery [<xref rid="R17" ref-type="bibr">17</xref>,<xref rid="R18" ref-type="bibr">18</xref>,<xref rid="R33" ref-type="bibr">33</xref>,<xref rid="R47" ref-type="bibr">47</xref>]; OR 0.94, 95% CI 0.59–1.51 versus all other modes [<xref rid="R17" ref-type="bibr">17</xref>,<xref rid="R18" ref-type="bibr">18</xref>,<xref rid="R33" ref-type="bibr">33</xref>]). Examining data from cART patients delivering at term also yielded nonsignificant results (Table <xref ref-type="table" rid="T3">3</xref>) [<xref rid="R17" ref-type="bibr">17</xref>].</p><p>When focusing on data stratified by CD4<sup>+</sup> or VL of the mother, only two studies [<xref rid="R16" ref-type="bibr">16</xref>,<xref rid="R17" ref-type="bibr">17</xref>] (with five individual effect sizes) were available. Among women with CD4<sup>+</sup> cell count more than 200 or VL less than 400 only, the OR for infant HIV infection was 0.36 (95% CI 0.17–0.79) compared with vaginal delivery [<xref rid="R16" ref-type="bibr">16</xref>,<xref rid="R17" ref-type="bibr">17</xref>] and 0.46 (95% CI 0.24–0.88) compared with all other modes [<xref rid="R16" ref-type="bibr">16</xref>,<xref rid="R17" ref-type="bibr">17</xref>]. However, in both comparisons, there was no longer a statistically significant association between ECS and infant HIV infection when examining data for women with CD4<sup>+</sup> cell count more than 200, VL less than 400, and delivery at term only (OR 0.59, 95% CI 0.21–1.63 versus vaginal delivery; OR 0.73, 95% CI 0.29–1.8 versus all other modes of delivery) [<xref rid="R17" ref-type="bibr">17</xref>].</p><p>Finally, meta-analysis of data from LMICs showed that ECS was associated with reduced infant HIV infection compared with vaginal delivery (OR 0.27, 95% CI 0.16–0.45) and all other modes of delivery (OR 0.34, 95% CI 0.15–0.78, substantial heterogeneity) [<xref rid="R18" ref-type="bibr">18</xref>,<xref rid="R27" ref-type="bibr">27</xref>,<xref rid="R37" ref-type="bibr">37</xref>,<xref rid="R43" ref-type="bibr">43</xref>,<xref rid="R44" ref-type="bibr">44</xref>].</p></sec><sec><title>Other infant health outcomes</title><p>Two observational studies from the United States and Puerto Rico [<xref rid="R33" ref-type="bibr">33</xref>] and from multiple countries in Latin America and the Caribbean [<xref rid="R32" ref-type="bibr">32</xref>] compared infant health outcomes in addition to HIV infection (Table <xref ref-type="table" rid="T4">4</xref>). Odds of infant respiratory distress syndrome increased with ECS compared with vaginal delivery but not with all other modes of delivery. ECS had no statistically significant difference in odds of transient tachypnea comparing with vaginal delivery (substantial heterogeneity) but increased odds comparing with all other modes. Results from the single study conducted in LMICs (multiple countries in Latin America and the Caribbean) were similar to meta-analytic results for infant respiratory distress syndrome, but showed greater odds of transient tachypnea compared with vaginal delivery (OR 7.10, 95% CI 2.09–24.12) [<xref rid="R32" ref-type="bibr">32</xref>]. No studies compared breastfeeding outcomes across modes of delivery.</p><table-wrap id="T4" position="float"><label>Table 4</label><caption><p>Meta-analytic results for other infant health outcomes, comparing modes of delivery.</p></caption><table frame="hsides" rules="groups"><thead><tr><td rowspan="1" colspan="1"></td><td colspan="4" rowspan="1">ECS versus vaginal delivery</td><td colspan="4" rowspan="1">ECS versus all other modes of delivery</td></tr><tr><td rowspan="1" colspan="1"></td><td rowspan="1" colspan="1">No. of studies</td><td rowspan="1" colspan="1">No. of participants</td><td rowspan="1" colspan="1">OR (95% CI)</td><td rowspan="1" colspan="1"><italic>I</italic><sup>2</sup></td><td rowspan="1" colspan="1">No. of studies</td><td rowspan="1" colspan="1">No. of participants</td><td rowspan="1" colspan="1">OR (95% CI)</td><td rowspan="1" colspan="1"><italic>I</italic><sup>2</sup></td></tr></thead><tbody><tr><td colspan="9" rowspan="1">Observational studies</td></tr><tr><td rowspan="1" colspan="1"> Respiratory distress syndrome</td><td rowspan="1" colspan="1">2 [<xref rid="R32" ref-type="bibr">32</xref>, <xref rid="R33" ref-type="bibr">33</xref>]</td><td rowspan="1" colspan="1">2056</td><td rowspan="1" colspan="1">2.77 (1.58–4.88)</td><td rowspan="1" colspan="1">0</td><td rowspan="1" colspan="1">2 [<xref rid="R32" ref-type="bibr">32</xref>, <xref rid="R33" ref-type="bibr">33</xref>]</td><td rowspan="1" colspan="1">2637</td><td rowspan="1" colspan="1">1.43 (0.94–2.18)</td><td rowspan="1" colspan="1">0</td></tr><tr><td rowspan="1" colspan="1"> Respiratory distress syndrome, LMICs only<xref ref-type="table-fn" rid="TF4-1"><sup>a</sup></xref></td><td rowspan="1" colspan="1">1 [<xref rid="R32" ref-type="bibr">32</xref>]</td><td rowspan="1" colspan="1">1078</td><td rowspan="1" colspan="1">2.73 (1.24–5.98)</td><td rowspan="1" colspan="1">–</td><td rowspan="1" colspan="1">1 [<xref rid="R32" ref-type="bibr">32</xref>]</td><td rowspan="1" colspan="1">1443</td><td rowspan="1" colspan="1">1.48 (0.83–2.63)</td><td rowspan="1" colspan="1">–</td></tr><tr><td rowspan="1" colspan="1"> Transient tachypnea of the newborn</td><td rowspan="1" colspan="1">2 [<xref rid="R32" ref-type="bibr">32</xref>, <xref rid="R33" ref-type="bibr">33</xref>]</td><td rowspan="1" colspan="1">2056</td><td rowspan="1" colspan="1">3.17 (0.79–12.76)</td><td rowspan="1" colspan="1">74.39</td><td rowspan="1" colspan="1">2 [<xref rid="R32" ref-type="bibr">32</xref>, <xref rid="R33" ref-type="bibr">33</xref>]</td><td rowspan="1" colspan="1">2637</td><td rowspan="1" colspan="1">1.73 (1.09–2.74)</td><td rowspan="1" colspan="1">0</td></tr><tr><td rowspan="1" colspan="1"> Transient tachypnea of the newborn, LMICs only<xref ref-type="table-fn" rid="TF4-1"><sup>a</sup></xref></td><td rowspan="1" colspan="1">1 [<xref rid="R32" ref-type="bibr">32</xref>]</td><td rowspan="1" colspan="1">1078</td><td rowspan="1" colspan="1">7.10 (2.09–24.12)</td><td rowspan="1" colspan="1">–</td><td rowspan="1" colspan="1">1 [<xref rid="R32" ref-type="bibr">32</xref>]</td><td rowspan="1" colspan="1">1443</td><td rowspan="1" colspan="1">1.73 (0.91–3.27)</td><td rowspan="1" colspan="1">–</td></tr></tbody></table><table-wrap-foot><fn fn-type="other"><p>OR, odds ratio; CI, confidence interval; ECS, elective c-section; LMIC, low-income/middle-income countries.</p></fn><fn fn-type="other" id="TF4-1"><p><sup>a</sup>Countries classified as lower income, lower-middle, or upper-middle income by the World Bank.</p></fn></table-wrap-foot></table-wrap></sec></sec><sec sec-type="discussion"><title>Discussion</title><p>This systematic review identified a large body of evidence comparing outcomes across different modes of delivery for women living with HIV. However, most studies were conducted in high-income countries and among women who were not on current highly effective ART regimens. Altogether, data from a single RCT and multiple observational studies indicate that ECS reduces the risk of infant HIV infection in the absence of ART. However, the association between ECS and infant HIV infection was nonsignificant in most stratified analyses of studies conducted in the cART era and among women on cART, women with higher CD4<sup>+</sup> cell counts or lower VLs, and women whose deliveries were at term. Limited data on other maternal outcomes and infant health outcomes do suggest increased maternal and infant morbidity associated with ECS compared with vaginal birth, as is seen with HIV-uninfected women. However, many outcomes were relatively minor or less problematic with accurate dating of pregnancy and ECS at term.</p><p>The risk–benefit ratio of ECS likely depends upon the underlying rate of vertical HIV transmission, as well as the risks of both maternal and infant morbidities and mortality associated with ECS and other modes of delivery. For women who are on ART and virally suppressed, the risk of vertical HIV transmission is relatively low. For women in high-income countries with access to quality obstetric services, the risks associated with ECS are also relatively low. However, the risk of vertical transmission increases greatly for women in the absence of effective ART while the risks of ECS increase for women without access to high-quality obstetric services. We found only three studies from sub-Saharan Africa, and whereas one study from Kenya reported on maternal mortality, none reported on maternal or infant morbidity outcomes other than HIV infection. Future studies from sub-Saharan Africa and other LMICs would help to clarify the risks and benefits in such settings and provide useful evidence for policy-makers.</p><p>The findings from this review suggest routine ECS for women living with HIV may not be appropriate; instead, individual patients and clinicians should consider the risks and benefits for specific clients, and women's autonomy to choose their mode of delivery should be respected. This is consistent with other national guidelines and recommendations from professional groups [<xref rid="R50" ref-type="bibr">50</xref>–<xref rid="R53" ref-type="bibr">53</xref>]. US and UK guidelines, while not recommending routine ECS for all women living with HIV, do recommend that clinicians consider ECS at higher VLs. The American College of Obstetricians and Gynecologists has recommended considering ECS when VL more than 1000 [<xref rid="R51" ref-type="bibr">51</xref>]. UK guidelines recommend ECS with VL more than 1000 and recommend considering ECS when VL = 50–999, ‘taking into account the actual VL, the trajectory of the VL, length of time on treatment, adherence issues, obstetric factors and the woman's views’ [<xref rid="R53" ref-type="bibr">53</xref>]. An examination of national guidelines across 23 European countries found that 95% ‘included the recommendation that HIV-positive women on successful cART with a very low or undetectable VL (<1000) can have a vaginal delivery’ [<xref rid="R50" ref-type="bibr">50</xref>]. The 2015 WHO Statement on Cesarean Section Rates emphasized the need to avoid unnecessary c-sections, especially in settings that lack the facilities and/or capacity to properly conduct safe surgery and treat surgical complications, which can extend many years beyond the current delivery and affect the health of the woman, her child, and future pregnancies [<xref rid="R3" ref-type="bibr">3</xref>]. However, there may be specific clinical indications, such as raised VL at delivery or known ART resistance, where ECS may be further considered, highlighting the need for individual-level consideration of risks and benefits of ECS in addition to national guidelines. When c-section is medically indicated, it should be available, accessible, and safe for all women, including women living with HIV.</p><p>It is critically important to emphasize respect for women's autonomy regarding mode of delivery. In the largest survey conducted by and for women living with HIV globally, women living with HIV reported experiencing routine lack of inclusion or choice in decision-making about their own sexual and reproductive healthcare [<xref rid="R6" ref-type="bibr">6</xref>]. Principles of human rights must be embedded in all healthcare policies, practices, and training, and coercion of any kind is never acceptable [<xref rid="R54" ref-type="bibr">54</xref>].</p><p>The issue of mode of delivery for women living with HIV is important, and no systematic review has been conducted to update the evidence in the past 12 years. Our review used a broad search strategy, double data extraction, and careful assessment of study quality. However, the findings must be seen in light of several limitations. Studies that defined ECS used a definition consistent with the one used for this review; however, the minority of studies that did not clearly specify how they defined ECS may have introduced heterogeneity into the review. Few studies were available from recent years, from women on cART, and for different subgroups. Few studies were also available from LMICs where surgical skills and health system capacity are most limited; we identified only three studies from sub-Saharan Africa and none reported maternal and infant morbidity outcomes beyond HIV transmission. All but one were observational studies with their well established and inherent limitations and bias in assessing intervention effects; in the absence of randomization, providers likely directed women to ECS or other modes of delivery based on systematically different sociodemographic characteristics, clinical presentation, or staffing capabilities. The only RCT was published in 1999. In meta-analyses, we attempted to include only nonoverlapping participant data, but the complex set of overlaps across studies made this difficult, and it is possible that duplicate data were included in some analyses. Meta-analyses also often had few studies, large CIs, and sometimes considerable statistical heterogeneity. This review points to the need for further research, particularly in low-income and middle-income countries, and particularly in sub-Saharan Africa where the majority of women living with HIV reside. However, reductions in vertical transmission due to cART mean future studies must be large (and thus expensive) to identify statistically significant differences across modes of delivery. The evidence base is therefore unlikely to be significantly strengthened in the future.</p><p>In conclusion, our findings suggest that while ECS may be protective against infant HIV infection in the absence of effective ART, this effect was not statistically significant among women on cART or who are at term and virally suppressed, and there are other risks to mothers and infants associated with ECS. Risks and benefits are likely to differ across settings. Clinicians and healthcare providers should consider the risks and benefits for individual clients, and respect women's autonomy to choose their mode of delivery.</p></sec><sec><title>Acknowledgements</title><p>This review was commissioned by the WHO, Department of Reproductive Health and Research, to inform the updated WHO consolidated guideline on sexual and reproductive health and rights of women living with HIV. We would like to thank Marie-Louise Newell for her insight on the European Collaborative Study overlapping cohorts and Jennifer Read for her careful review and feedback on the original review protocol and final manuscript.</p><p>C.E.K., A.P.B., and M.N. conceived the study and developed the review methods and protocol. C.E.K. performed the literature search and oversaw screening and data extraction. P.T.Y. and S.P. extracted data. C.E.K., P.T.Y., and S.P. conducted the analysis. C.E.K. led the writing of the manuscript with significant help from P.T.Y. S.P., A.P.B., and M.N. commented on and contributed to the text. All authors reviewed and approved the final manuscript.</p><p>The study was funded by the WHO.</p><sec><title>Conflicts of interest</title><p>The views and opinions expressed herein are those of the authors and not necessarily those of the WHO.</p><p>The authors declare no competing interests.</p></sec></sec></body><back><fn-group><fn fn-type="other"><p>Supplemental digital content is available for this article. 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