{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,25]],"date-time":"2026-10-25T00:56:58Z","timestamp":1792889818557,"version":"4.5.0"},"reference-count":0,"publisher":"Georg Thieme Verlag KG","issue":"02","license":[{"start":{"date-parts":[[2019,10,25]],"date-time":"2019-10-25T00:00:00Z","timestamp":1571961600000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"DOI":"10.13039\/100013595","name":"AMAG Pharmaceuticals","doi-asserted-by":"crossref","id":[{"id":"10.13039\/100013595","id-type":"DOI","asserted-by":"crossref"}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Am J Perinatol"],"published-print":{"date-parts":[[2020,1]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:p>Background\u2003Women with a history of spontaneous preterm birth (SPTB) are at a significantly increased risk for recurrent preterm birth (PTB). To date, only one large U.S. clinical trial comparing 17-OHPC (17-\u03b1-hydroxyprogesterone caproate or \u201c17P\u201d) to placebo has been published, and this trial was stopped early due to a large treatment benefit.<\/jats:p>\n                  <jats:p>Objective\u2003This study aimed to assess whether 17-OHPC decreases recurrent PTB and neonatal morbidity in women with a prior SPTB in a singleton gestation.<\/jats:p>\n                  <jats:p>Study Design\u2003This was a double-blind, placebo-controlled international trial involving women with a previous singleton SPTB (clinicaltrials.gov: NCT 01004029). Women were enrolled at 93 clinical centers (41 in the United States and 52 outside the United States) between 160\/7 to 206\/7 weeks in a 2:1 ratio, to receive either weekly intramuscular (IM) injections of 250\u2009mg of 17-OHPC or an inert oil placebo; treatment was continued until delivery or 36 weeks. Co-primary outcomes were PTB\u2009&lt;\u200935 weeks and a neonatal morbidity composite index. The composite included any of the following: neonatal death, grade 3 or 4 intraventricular hemorrhage, respiratory distress syndrome, bronchopulmonary dysplasia, necrotizing enterocolitis, or proven sepsis. A planned sample size of 1,707 patients was estimated to provide 98% power to detect a 30% reduction in PTB\u2009&lt;\u200935 weeks (30% to 21%) and 90% power to detect a 35% reduction in neonatal composite index (17%\u201311%) using a two-sided type-I error of 5%. Finally, this sample size would also provide 82.8% power to rule out a doubling in the risk of fetal\/early infant death assuming a 4% fetal\/early infant death rate. Analysis was performed according to the intention-to-treat principle.<\/jats:p>\n                  <jats:p>Results\u2003Baseline characteristics between the 1,130 women who received 17-OHPC and 578 women who received placebo were similar. Overall, 87% of enrolled women were Caucasian, 12% had &gt;1 prior SPTB, 7% smoked cigarettes, and 89% were married\/lived with partner. Prior to receiving study drug, 73% women had a transvaginal cervical length measurement performed and &lt;2% had cervical shortening &lt;25\u2009mm. There were no significant differences in the frequency of PTB\u2009&lt;\u200935 weeks (17-OHPC 11.0% vs. placebo 11.5%; relative risk\u2009=\u20090.95 [95% confidence interval (CI): 0.71\u20131.26]) or neonatal morbidity index (17-OHPC 5.6% vs. placebo 5.0%; relative risk\u2009=\u20091.12 [95% CI: 0.68\u20131.61]). There were also no differences in frequency of fetal\/early infant death (17-OHPC 1.7% vs. placebo 1.9%; relative risk\u2009=\u20090.87 [95% CI: 0.4\u20131.81]. Maternal outcomes were also similar. In the subgroup of women enrolled in the United States (n\u2009=\u2009391; 23% of all patients), although the rate of PTB\u2009&lt;\u200935 weeks was higher than the overall study population, there were no statistically significant differences between groups (15.6% vs. 17.6%; relative risk\u2009=\u20090.88 [95% CI: 0.55, 1.40].<\/jats:p>\n                  <jats:p>Conclusion\u2003In this study population, 17-OHPC did not decrease recurrent PTB and was not associated with increased fetal\/early infant death.<\/jats:p>","DOI":"10.1055\/s-0039-3400227","type":"journal-article","created":{"date-parts":[[2019,10,25]],"date-time":"2019-10-25T19:14:09Z","timestamp":1572030849000},"page":"127-136","source":"Crossref","is-referenced-by-count":202,"title":["17-OHPC to Prevent Recurrent Preterm Birth in Singleton Gestations (PROLONG Study): A Multicenter, International, Randomized Double-Blind Trial"],"prefix":"10.1055","volume":"37","author":[{"given":"Sean C.","family":"Blackwell","sequence":"additional","affiliation":[{"name":"Department of Obstetrics, Gynecology, and Reproductive Sciences, McGovern Medical School-UTHealth, Houston, Texas"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Cynthia","family":"Gyamfi-Bannerman","sequence":"additional","affiliation":[{"name":"Division of Maternal-Fetal Medicine, Department of Obstetrics and Gynecology, Columbia University Irving Medical Center, New York, New York"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"suffix":"Jr.","given":"Joseph R.","family":"Biggio","sequence":"additional","affiliation":[{"name":"Section of Maternal Fetal Medicine, Women's Services, Ochsner Health Systems, New Orleans, Louisiana"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Suneet P.","family":"Chauhan","sequence":"additional","affiliation":[{"name":"Department of Obstetrics, Gynecology, and Reproductive Sciences, McGovern Medical School-UTHealth, Houston, Texas"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Brenna L.","family":"Hughes","sequence":"additional","affiliation":[{"name":"Department of Obstetrics and Gynecology, Duke University, Durham, North Carolina"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Judette M.","family":"Louis","sequence":"additional","affiliation":[{"name":"Department of Obstetrics and Gynecology, University of South Florida, Tampa, Florida"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Tracy A.","family":"Manuck","sequence":"additional","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 S.","family":"Miller","sequence":"additional","affiliation":[{"name":"Valley Perinatal Services, Watching Over Mothers and Babies Foundation, Tucson, Arizona"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Anita F.","family":"Das","sequence":"additional","affiliation":[{"name":"Das Consulting, Guerneville, California"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"George R.","family":"Saade","sequence":"additional","affiliation":[{"name":"Department of Obstetrics and Gynecology, University of Texas Medical Branch, University of Texas, Galveston, Texas"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Peter","family":"Nielsen","sequence":"additional","affiliation":[{"name":"Division of Maternal Fetal Medicine, Department of Obstetrics and Gynecology, Baylor College of Medicine and The Children's Hospital of San Antonio, San Antonio, Texas"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jeff","family":"Baker","sequence":"additional","affiliation":[{"name":"Clinical Research Prime, Idaho Falls, Idaho"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Oleksandr M.","family":"Yuzko","sequence":"additional","affiliation":[{"name":"Department of Obstetrics and Gynecology, Bukovinian State Medical University, Chernivtsi, Ukraine"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Galyna I.","family":"Reznichenko","sequence":"additional","affiliation":[{"name":"Department of Obstetrics and Gynecology, Clinical Maternity Hospital # 4, Zaporizhzhya, Ukraine"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Nataliya Y.","family":"Reznichenko","sequence":"additional","affiliation":[{"name":"Department of Obstetrics and Gynecology, Clinical Maternity Hospital # 4, Zaporizhzhya, Ukraine"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Oleg","family":"Pekarev","sequence":"additional","affiliation":[{"name":"Department of Obstetrics and Gynecology, State Government-financed Healthcare Institution of Novosibirsk Region, Novosibirsk, Russia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Nina","family":"Tatarova","sequence":"additional","affiliation":[{"name":"Department of Obstetrics and Gynecology, Saint-Petersburg Government-financed Healthcare Institution \u201cMaternity Hospital #17,\u201d Saint-Petersburg, Russia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jennifer","family":"Gudeman","sequence":"additional","affiliation":[{"name":"AMAG Pharmaceuticals, Inc, Medical Development, Waltham, Massachusetts"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Robert","family":"Birch","sequence":"additional","affiliation":[{"name":"Formerly at AMAG Pharmaceuticals, Inc, Medical Development, Waltham, Massachusetts"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Michael J.","family":"Jozwiakowski","sequence":"additional","affiliation":[{"name":"Jozwiakowski Pharma Consulting LLC, Santa Fe, New Mexico"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Monique","family":"Duncan","sequence":"additional","affiliation":[{"name":"AMAG Pharmaceuticals, Inc, Medical Development, Waltham, Massachusetts"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Laura","family":"Williams","sequence":"additional","affiliation":[{"name":"AMAG Pharmaceuticals, Inc, Medical Development, Waltham, Massachusetts"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Julie","family":"Krop","sequence":"additional","affiliation":[{"name":"AMAG Pharmaceuticals, Inc, Medical Development, Waltham, Massachusetts"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"194","published-online":{"date-parts":[[2019,10,25]]},"container-title":["American Journal of Perinatology"],"original-title":[],"language":"en","link":[{"URL":"http:\/\/www.thieme-connect.de\/products\/ejournals\/pdf\/10.1055\/s-0039-3400227.pdf","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2020,1,18]],"date-time":"2020-01-18T18:31:18Z","timestamp":1579372278000},"score":1,"resource":{"primary":{"URL":"http:\/\/www.thieme-connect.de\/DOI\/DOI?10.1055\/s-0039-3400227"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2019,10,25]]},"references-count":0,"journal-issue":{"issue":"02","published-online":{"date-parts":[[2020,1,18]]},"published-print":{"date-parts":[[2020,1]]}},"URL":"https:\/\/doi.org\/10.1055\/s-0039-3400227","relation":{},"ISSN":["0735-1631","1098-8785"],"issn-type":[{"value":"0735-1631","type":"print"},{"value":"1098-8785","type":"electronic"}],"subject":[],"published":{"date-parts":[[2019,10,25]]}}}