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This study aimed at assessing if the adjunction of two doses of azithromycin to sulfadoxine-pyrimethamine for the intermittent preventive treatment of malaria in pregnancy can reduce LBW.<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Methods<\/jats:title>\n                <jats:p>A two parallel-groups, open-label randomized controlled trial involving pregnant women (16 to 35\u00a0years of age and 12 to 24\u00a0weeks of gestation as confirmed by last menstrual period or fundal height) was conducted in rural Burkina Faso. Women were assigned in a 1:1 ratio either to use azithromycin (1\u00a0g daily for 2\u00a0days) during the second and third trimesters of pregnancy plus monthly sulfadoxine-pyrimethamine (1500\/75\u00a0mg) (SPAZ) (intervention) or to continue using a monthly sulfadoxine-pyrimethamine (1500\/75\u00a0mg) (SP) (control). Primary outcome was a LBW (birth weight measured within 24\u00a0h after birth\u2009&lt;\u20092500\u00a0g). Secondary outcomes including stillbirth, preterm birth or miscarriage are reported together with safety data.<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Results<\/jats:title>\n                <jats:p>A total of 992 pregnant women underwent randomization (496 per group) and 898 (90.5%) valid birth weights were available (450 in SPAZ and 448 in SP). LBW incidence was 8.7% (39\/450) in SPAZ and 9.4% (42\/448) in controls (p-value\u2009=\u20090.79). Compared with controls, pregnant women with SPAZ showed a risk ratio (RR) of 1.16 (95% confidence interval (CI 0.64\u20132.08]) for preterm births, 0.75 (95% CI 0.17\u20133.35) for miscarriage and 0.64 (95% CI 0.25\u20131.64) for stillbirths. No treatment-related serious adverse events (SAEs) have been observed, and there was no significant difference in the number of SAEs (13.5% [67\/496] in SPAZ, 16.7% [83\/496] in SP, p-value\u2009=\u20090.18) or AEs (17.1% [85\/496] in SPAZ, 18.8% [93\/496] in SP, p-value\u2009=\u20090.56).<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Conclusion<\/jats:title>\n                <jats:p>Adequate prevention regimen with monthly sulfadoxine-pyrimethamine given to all pregnant women has been proved to reduce the risk of LBW in malaria endemic areas. Adding azithromycin to the regimen does not offer further benefits, as far as women receive a malaria prevention regimen early enough during pregnancy.<\/jats:p>\n                <jats:p><jats:italic>Trial registration<\/jats:italic> Pan African Clinical Trial Registry (<jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" ext-link-type=\"uri\" xlink:href=\"https:\/\/pactr.samrc.ac.za\/Search.aspx\">https:\/\/pactr.samrc.ac.za\/Search.aspx<\/jats:ext-link>): PACTR201808177464681. Registered 21 August 2018.<\/jats:p>\n              <\/jats:sec>","DOI":"10.1186\/s12936-023-04530-5","type":"journal-article","created":{"date-parts":[[2023,3,26]],"date-time":"2023-03-26T20:52:42Z","timestamp":1679863962000},"update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":9,"title":["Effects of maternal antenatal treatment with two doses of azithromycin added to monthly sulfadoxine-pyrimethamine for the prevention of low birth weight in Burkina Faso: an open-label randomized controlled trial"],"prefix":"10.1186","volume":"22","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-5651-2035","authenticated-orcid":false,"given":"Moussa","family":"Lingani","sequence":"first","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Serge H.","family":"Zango","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Innocent","family":"Val\u00e9a","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"S\u00e9kou","family":"Samadoulougou","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Georges","family":"Som\u00e9","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Ma\u00efmouna","family":"Sanou","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Berenger","family":"Kabor\u00e9","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Toussaint","family":"Rouamba","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Herman","family":"Sorgho","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Marc C.","family":"Tahita","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Karim","family":"Derra","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Mich\u00e8le","family":"Dramaix","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Halidou","family":"Tinto","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Philippe","family":"Donnen","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Annie","family":"Robert","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"297","published-online":{"date-parts":[[2023,3,17]]},"reference":[{"key":"4530_CR1","doi-asserted-by":"publisher","first-page":"189","DOI":"10.1016\/S0140-6736(14)60496-7","volume":"384","author":"JE Lawn","year":"2014","unstructured":"Lawn JE, Blencowe H, Oza S, You D, Lee ACC, Waiswa P, et al. 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All participants provided a written informed consent prior to their participation. All methods were performed in accordance with the relevant guidelines and regulations.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethics approval and consent to participate"}},{"value":"Not applicable.","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Consent for publication"}},{"value":"The authors declare that they have no competing interests.","order":4,"name":"Ethics","group":{"name":"EthicsHeading","label":"Competing interests"}}],"article-number":"101"}}