{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,6,1]],"date-time":"2026-06-01T23:09:53Z","timestamp":1780355393733,"version":"3.54.1"},"reference-count":27,"publisher":"Wiley","issue":"10","license":[{"start":{"date-parts":[[2019,6,1]],"date-time":"2019-06-01T00:00:00Z","timestamp":1559347200000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"content-domain":{"domain":["obgyn.onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Acta Obstet Gynecol Scand"],"published-print":{"date-parts":[[2019,10]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:sec><jats:title>Introduction<\/jats:title><jats:p>Second\u2010trimester vaginal bleeding increases the risk of spontaneous preterm birth. We aimed to examine the efficacy of vaginal progesterone to reduce preterm birth rate in women with second\u2010trimester vaginal bleeding.<\/jats:p><\/jats:sec><jats:sec><jats:title>Material and methods<\/jats:title><jats:p>Two\u2010center, double\u2010blind, placebo\u2010controlled trial involving pregnant women with second\u2010trimester vaginal bleeding. Women with documented uterine bleeding were randomly assigned in a 1:1 ratio to receive 200\u00a0mg of micronized vaginal progesterone or placebo once daily at 16\u201026\u00a0weeks until 36\u00a0weeks of gestation. Women who had prior preterm birth or short cervix diagnosed before recruitment were not eligible. The primary outcome was spontaneous delivery &lt;37\u00a0weeks. Clinical Trial Registration: clinicaltrials.gov Identifier: NCT01269450.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>Between March 2011 and January 2017, 128 women gave consent and were randomized; 16 withdrew consent and 3 had a second\u2010trimester termination of pregnancy. The final analysis included 109 women: 60 in the progesterone group and 49 in the placebo group. Demographic and obstetric characteristics did not differ between the groups. Primary outcome occurred in 19 (31.7%) and 12 (24.5%) in the progesterone and placebo groups, respectively (<jats:styled-content style=\"fixed-case\">odds ratio [OR<\/jats:styled-content>] 1.32; 95% <jats:styled-content style=\"fixed-case\">confidence interval [CI]<\/jats:styled-content> 0.55\u20103.16; <jats:italic>P\u00a0<\/jats:italic>=<jats:italic>\u00a0<\/jats:italic>0.53). The proportion of births &lt;34\u00a0weeks was similar between the groups (<jats:styled-content style=\"fixed-case\">OR<\/jats:styled-content> 1.19; 95% <jats:styled-content style=\"fixed-case\">CI<\/jats:styled-content> 0.47\u20103.02; <jats:italic>P\u00a0<\/jats:italic>=<jats:italic>\u00a0<\/jats:italic>0.72), as were the survival curves from randomization to delivery (hazard ratio, 1.24; 95% <jats:styled-content style=\"fixed-case\">CI<\/jats:styled-content>, 0.60\u20102.56; <jats:italic>P\u00a0<\/jats:italic>=<jats:italic>\u00a0<\/jats:italic>0.57). There were no significant differences in neonatal morbidities between the groups. The study was ended prematurely because of slow recruitment.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusions<\/jats:title><jats:p>Antepartum vaginal progesterone does not seem to reduce the incidence of preterm birth in women with second\u2010trimester bleeding.<\/jats:p><\/jats:sec>","DOI":"10.1111\/aogs.13641","type":"journal-article","created":{"date-parts":[[2019,5,14]],"date-time":"2019-05-14T02:38:16Z","timestamp":1557801496000},"page":"1318-1325","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":5,"title":["Double\u2010blind randomized trial of progesterone to prevent preterm birth in second\u2010trimester bleeding"],"prefix":"10.1111","volume":"98","author":[{"given":"Raed","family":"Salim","sequence":"first","affiliation":[{"name":"Department of Obstetrics and Gynecology Emek Medical Center Afula Israel"},{"name":"Rappaport Faculty of Medicine Technion Haifa Israel"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Marwan","family":"Hakim","sequence":"additional","affiliation":[{"name":"Nazareth Hospital EMMS Nazareth Israel"},{"name":"Faculty of Medicine in the Galilee Bar\u2010Ilan University Ramat Gan Israel"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Noah","family":"Zafran","sequence":"additional","affiliation":[{"name":"Department of Obstetrics and Gynecology Emek Medical Center Afula Israel"},{"name":"Rappaport Faculty of Medicine Technion Haifa Israel"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Zohar","family":"Nachum","sequence":"additional","affiliation":[{"name":"Department of Obstetrics and Gynecology Emek Medical Center Afula Israel"},{"name":"Rappaport Faculty of Medicine Technion Haifa Israel"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Shabtai","family":"Romano","sequence":"additional","affiliation":[{"name":"Department of Obstetrics and Gynecology Emek Medical Center Afula Israel"},{"name":"Rappaport Faculty of Medicine Technion Haifa Israel"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Gali","family":"Garmi","sequence":"additional","affiliation":[{"name":"Department of Obstetrics and Gynecology Emek Medical Center Afula Israel"},{"name":"Rappaport Faculty of Medicine Technion Haifa Israel"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2019,6]]},"reference":[{"key":"e_1_2_9_2_1","first-page":"963","article-title":"ACOG Committee Opinion number 419 October 2008 (replaces no. 291, November 2003). 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