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Having a short cervix increases the risk of preterm birth, which can be accessed by a transvaginal ultrasound scan during the second trimester. In women with a short cervix, vaginal progesterone and pessary can both reduce this risk, which progesterone more established than cervical pessary. The aim of this study is to compare the use of vaginal progesterone alone versus the association of progesterone plus pessary to prevent preterm birth in women with a short cervix.<\/jats:p>\n <\/jats:sec>\n Methods<\/jats:title>\n This is a pragmatic open-label randomized controlled trial that will take place in 17 health facilities in Brazil. Pregnant women will be screened for a short cervix with a transvaginal ultrasound between 18 0\/7<\/jats:sup> until 22 6\/7<\/jats:sup> weeks of gestational age. Women with a cervical length below or equal to 30\u2009mm will be randomized to the combination of progesterone (200\u2009mg) and pessary or progesterone (200\u2009mg) alone until 36\u2009+\u20090\u2009weeks.<\/jats:p>\n The primary outcome will be a composite of neonatal adverse events, to be collected at 10\u2009weeks after birth. The analysis will be by intention to treat. The sample size is 936 women, and a prespecified subgroup analysis is planned for cervical length (=\u2009<\u2009or\u2009>\u200925\u2009mm).<\/jats:p>\n Categorical variables will be expressed as a percentage and continuous variables as mean with standard deviation. Time to delivery will be assessed with Kaplan-Meier analysis and Cox proportional hazard analysis.<\/jats:p>\n <\/jats:sec>\n Discussion<\/jats:title>\n I<\/jats:bold>n clinical practice, the combination of progesterone and pessary is common however, few studies have studied this association. The combination of treatment might act in both the biochemical and mechanical routes related to the onset of preterm birth.<\/jats:p>\n <\/jats:sec>\n Trial registration<\/jats:title>\n Brazilian Clinical Trial Registry<\/jats:italic> (ReBec) RBR-3t8prz, UTN: U1111\u20131164-2636<\/jats:ext-link>, 2014\/11\/18.<\/jats:p>\n <\/jats:sec>","DOI":"10.1186\/s12884-019-2513-2","type":"journal-article","created":{"date-parts":[[2019,11,27]],"date-time":"2019-11-27T12:03:50Z","timestamp":1574856230000},"update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":19,"title":["A randomized controlled trial on the use of pessary plus progesterone to prevent preterm birth in women with short cervical length (P5 trial)"],"prefix":"10.1186","volume":"19","author":[{"name":"The P5 Working Group","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-5739-0009","authenticated-orcid":false,"given":"Rodolfo C.","family":"Pacagnella","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ben W.","family":"Mol","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Anderson","family":"Borovac-Pinheiro","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"suffix":"Jr.","given":"Renato","family":"Passini","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Marcelo L.","family":"Nomura","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kleber Cursino","family":"Andrade","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Nathalia","family":"Ellovitch","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Karayna Gil","family":"Fernandes","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Tha\u00edsa Guedes","family":"Bortoletto","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Cynara Maria","family":"Pereira","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Maria Julia","family":"Miele","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Marcelo Santucci","family":"Fran\u00e7a","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jose G.","family":"Cecatti","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"297","published-online":{"date-parts":[[2019,11,27]]},"reference":[{"key":"2513_CR1","volume-title":"Born too soon","author":"World Health Organization","year":"2012","unstructured":"World Health Organization. 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Each local Institutional Review Boards also approved the study protocol (a list of ethic committee is available in Additional\u00a0file\u00a0). Protocol modifications will be reported to each relevant part including national and local institutional review boards and will be available to trial participants through the project website, to the investigators by an internal bulletin, to the registries and journals by publications, and to regulators by the review board report. A written informed consent will be obtained from study participants. In case of an eligible participant under 18\u2009years old, a consent form will be signed for both the underaged participant and his\/her legal guardian\/parent before been admitted into the study.","order":1,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethics approval and consent to participate"}},{"value":"Not applicable.","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":"442"}}