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The administration of progesterone and related compounds has been proposed as a strategy to prevent preterm birth. The objective of this trial was to determine whether prophylactic administration of vaginal progesterone reduces the risk of preterm birth in women with a history of spontaneous preterm birth.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>This randomized, double\u2010blind, placebo\u2010 controlled, multinational trial enrolled and randomized 659 pregnant women with a history of spontaneous preterm birth. Between 18 + 0 and 22 + 6 weeks of gestation, patients were assigned randomly to once\u2010daily treatment with either progesterone vaginal gel or placebo until either delivery, 37 weeks' gestation or development of preterm rupture of membranes. The primary outcome was preterm birth at \u2264 32 weeks of gestation. The trial was analyzed using an intent\u2010to\u2010treat strategy.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>Baseline characteristics were similar in the two treatment groups. Progesterone did not decrease the frequency of preterm birth at \u2264 32 weeks. There was no difference between the groups with respect to the mean gestational age at delivery, infant morbidity or mortality or other maternal or neonatal outcome measures. Adverse events during the course of treatment were similar for the two groups.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusion<\/jats:title><jats:p>Prophylactic treatment with vaginal progesterone did not reduce the frequency of recurrent preterm birth (\u2264 32 <jats:italic>weeks<\/jats:italic>) in women with a history of spontaneous preterm birth. The effect of progesterone administration in patients at high risk for preterm delivery as determined by methods other than history alone (e.g. sonographic cervical length) requires further investigation. Copyright \u00a9 2007 ISUOG. Published by John Wiley &amp; Sons, Ltd.<\/jats:p><\/jats:sec>","DOI":"10.1002\/uog.5158","type":"journal-article","created":{"date-parts":[[2007,9,26]],"date-time":"2007-09-26T16:52:58Z","timestamp":1190825578000},"page":"687-696","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":240,"title":["Progesterone vaginal gel for the reduction of recurrent preterm birth: primary results from a randomized, double\u2010blind, placebo\u2010controlled trial"],"prefix":"10.1002","volume":"30","author":[{"given":"J. M.","family":"O'Brien","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"C. 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