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Iron supplementation could, however, increase malaria infections, notably in primigravidae who are most susceptible. The pathogenicity of other iron-utilizing pathogens could also increase, causing inflammation leading to increased risk of adverse birth outcomes. This paper reports pre-specified secondary birth outcomes from a safety trial in Burkina Faso in an area of high malaria endemicity. Primary outcomes from that trial had investigated effects of long-term weekly iron supplementation on malaria and genital tract infections in non-pregnant and pregnant women.<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Methods<\/jats:title>\n                <jats:p>A double-blind, randomized controlled trial. Nulliparous, mainly adolescent women, were individually randomized periconceptionally to receive weekly either 60\u00a0mg elemental iron and 2.8\u00a0mg folic acid, or 2.8\u00a0mg folic acid alone, continuing up to the first antenatal visit for those becoming pregnant. Secondary outcomes were ultrasound-dated gestational age, fetal growth, placental malaria, chorioamnionitis and iron biomarkers. Seasonal effects were assessed. Analysis was by intention to treat.<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Results<\/jats:title>\n                <jats:p>478 pregnancies occurred to 1959 women: 258\/980 women assigned iron and folic acid and 220\/979 women assigned folic acid alone. Malaria prevalence at the first antenatal visit was 53% (iron) and 55% (controls). Mean birthweight was 111\u00a0g lower in the iron group (95% CI 9:213\u00a0g, P\u2009=\u20090.033). Mean gestational ages were 264\u00a0days (iron) and 269\u00a0days (controls) (P\u2009=\u20090.012), with 27.5% under 37\u00a0weeks compared to 13.9% in controls (adjRR\u2009=\u20092.22; 95% CI 1.39\u20133.61) P\u2009&lt;\u20090.001). One-third of babies were growth restricted, but incidence did not differ by trial arm. Half of placentae had evidence of past malaria infection. C\u2013reactive protein\u2009&gt;\u20095\u00a0mg\/l was more common prior to births\u2009&lt;\u200937\u00a0weeks (adjRR\u2009=\u20092.06, 95% CI 1.04\u20134.10, P\u2009=\u20090.034). Preterm birth incidence during the rainy season was\u2009~\u200950% in the iron arm and\u2009&lt;\u200920% in controls (P\u2009=\u20090.001). Chorioamnionitis prevalence peaked in the dry season (P\u2009=\u20090.046), with no difference by trial arm (P\u2009=\u20090.14).<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Conclusion<\/jats:title>\n                <jats:p>Long-term weekly iron supplementation given to nulliparous women in a malaria endemic area was associated with higher risk of preterm birth in their first pregnancy.<\/jats:p>\n                <jats:p><jats:italic>Trial Registration<\/jats:italic> NCT01210040. Registered with Clinicaltrials.gov on 27th September 2010<\/jats:p>\n              <\/jats:sec>","DOI":"10.1186\/s12936-019-2797-8","type":"journal-article","created":{"date-parts":[[2019,5,6]],"date-time":"2019-05-06T15:00:53Z","timestamp":1557154853000},"update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":29,"title":["Excess risk of preterm birth with periconceptional iron supplementation in a malaria endemic area: analysis of secondary data on birth outcomes in a double blind randomized controlled safety trial in Burkina Faso"],"prefix":"10.1186","volume":"18","clinical-trial-number":[{"clinical-trial-number":"nct01210040","registry":"10.18810\/clinical-trials-gov"}],"author":[{"given":"Bernard","family":"Brabin","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sabine","family":"Gies","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Stephen A.","family":"Roberts","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Salou","family":"Diallo","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Olga M.","family":"Lompo","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Adama","family":"Kazienga","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Loretta","family":"Brabin","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sayouba","family":"Ouedraogo","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Halidou","family":"Tinto","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"297","published-online":{"date-parts":[[2019,5,6]]},"reference":[{"key":"2797_CR1","volume-title":"Guidelines: daily iron supplementation of adult women and adolescent girls","author":"WHO","year":"2016","unstructured":"WHO. 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Dec 2010); the Institutional Review Board of the Institute of Tropical Medicine, Antwerp, Belgium (IRB\/AB\/AC\/016. February 2011); the Antwerp University Hospital Ethics Committee (EC\/UZA. February 2011); in Burkina Faso the Institutional Ethics Committee of Centre Muraz (Comit\u00e9 d\u2019Ethique Institutionnel du Centre Muraz, and the National Ethics Committee (Comit\u00e9 Ethique pour la Recherche en Sant\u00e9, CERS. Ref 015-2010\/CE-CM. January 2011).Prior to enrolment the study team visited each village to inform village elders and senior women about trial objectives and for permission to invite young women to take part. Informed consent with right to withdraw (signature or thumb print) was granted by each participant, or by her appointed guardian if a minor or married at recruitment and repeated later by participants continuing to be followed in the pregnant cohort. Participants provided written informed consent for publication of research results.","order":1,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethics approval and consent to participate"}},{"value":"All participants gave consent for publication.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Consent for publication"}},{"value":"The authors declare that they have no competing interests.","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Competing interests"}}],"article-number":"161"}}