{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,28]],"date-time":"2026-10-28T02:26:39Z","timestamp":1793154399968,"version":"4.5.0"},"reference-count":0,"publisher":"Georg Thieme Verlag KG","issue":"12","content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Amer J Perinatol"],"published-print":{"date-parts":[[2018,10]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:p>The objective of this commentary is to describe the background, rationale, and methods of the PROLONG (Progestin's Role in Optimizing Neonatal Gestation) trial, which is a multicenter, multinational, placebo-controlled, randomized clinical trial (RCT) designed to assess the safety and efficacy of Makena (hydroxyprogesterone caproate injection, 250 mg\/mL) in reducing the risk of preterm birth (PTB) and neonatal morbidity\/mortality in women pregnant with a singleton gestation who had a previous singleton spontaneous PTB. The total sample size of the RCT will include 1,707 women. The trial has two coprimary outcomes: PTB less than 35 weeks and a composite neonatal morbidity and mortality index. This study sample size will provide 90% power to assess for a 35% reduction in neonatal morbidity and mortality. Secondary outcomes will include 2-year follow-up of infants. The trial is ongoing and targeted to complete recruitment in 2018.<\/jats:p>","DOI":"10.1055\/s-0038-1642062","type":"journal-article","created":{"date-parts":[[2018,4,27]],"date-time":"2018-04-27T22:47:15Z","timestamp":1524869235000},"page":"1228-1234","source":"Crossref","is-referenced-by-count":7,"title":["PROLONG Clinical Study Protocol: Hydroxyprogesterone Caproate to Reduce Recurrent Preterm Birth"],"prefix":"10.1055","volume":"35","author":[{"given":"Cynthia","family":"Gyamfi-Bannerman","sequence":"first","affiliation":[{"name":"Department of Obstetrics and Gynecology, Preterm Birth Prevention Center, Columbia University Medical Center, New York, New York"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"suffix":"Jr","given":"Joseph","family":"Biggio","sequence":"first","affiliation":[{"name":"Department of Obstetrics and Gynecology, University of Alabama at Birmingham, Birmingham, Alabama"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Suneet","family":"Chauhan","sequence":"first","affiliation":[{"name":"Department of Obstetrics, Gynecology, and Reproductive Sciences, The University of Texas Health Science Center at Houston, Houston, Texas"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Brenna","family":"Hughes","sequence":"first","affiliation":[{"name":"Department of Obstetrics and Gynecology, Duke University, Durham, North Carolina"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Judette","family":"Louis","sequence":"first","affiliation":[{"name":"Department of Obstetrics and Gynecology, Morsani College of Medicine, University of South Florida, Tampa, Florida"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Tracy","family":"Manuck","sequence":"first","affiliation":[{"name":"Division of Maternal-Fetal Medicine, Department of Obstetrics and Gynecology, University of North Carolina, Chapel Hill, North Carolina"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hugh","family":"Miller","sequence":"first","affiliation":[{"name":"Watching Over Mothers and Babies Foundation, Tucson, Arizona"},{"name":"Valley Perinatal Services, Tucson, Arizona"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Anita","family":"Das","sequence":"first","affiliation":[{"name":"Das Consulting, San Francisco, California"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Robert","family":"Birch","sequence":"first","affiliation":[{"name":"AMAG Pharmaceuticals, Inc, Waltham, Massachusetts"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Michael","family":"Jozwiakowski","sequence":"first","affiliation":[{"name":"Department of Research and Development, AMAG Pharmaceuticals, Inc., Waltham, Massachusetts"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sean","family":"Blackwell","sequence":"additional","affiliation":[{"name":"Department of Obstetrics, Gynecology, and Reproductive Sciences, The University of Texas Health Science Center at Houston, Houston, Texas"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"194","published-online":{"date-parts":[[2018,4,27]]},"container-title":["American Journal of Perinatology"],"original-title":[],"language":"en","link":[{"URL":"http:\/\/www.thieme-connect.de\/products\/ejournals\/pdf\/10.1055\/s-0038-1642062.pdf","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2018,9,25]],"date-time":"2018-09-25T22:33:56Z","timestamp":1537914836000},"score":1,"resource":{"primary":{"URL":"http:\/\/www.thieme-connect.de\/DOI\/DOI?10.1055\/s-0038-1642062"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2018,4,27]]},"references-count":0,"journal-issue":{"issue":"12","published-online":{"date-parts":[[2018,9,25]]},"published-print":{"date-parts":[[2018,10]]}},"URL":"https:\/\/doi.org\/10.1055\/s-0038-1642062","relation":{},"ISSN":["0735-1631","1098-8785"],"issn-type":[{"value":"0735-1631","type":"print"},{"value":"1098-8785","type":"electronic"}],"subject":[],"published":{"date-parts":[[2018,4,27]]}}}