{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,4,29]],"date-time":"2026-04-29T18:09:23Z","timestamp":1777486163819,"version":"3.51.4"},"reference-count":48,"publisher":"MDPI AG","issue":"3","license":[{"start":{"date-parts":[[2026,1,27]],"date-time":"2026-01-27T00:00:00Z","timestamp":1769472000000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"DOI":"10.13039\/100000865","name":"Bill & Melinda Gates Foundation","doi-asserted-by":"crossref","id":[{"id":"10.13039\/100000865","id-type":"DOI","asserted-by":"crossref"}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Diagnostics"],"abstract":"<jats:p>Objective: This study assessed the efficacy of the cervical pessary combined with progesterone to prevent preterm birth in pregnant women with short cervix and previous preterm birth. Methods: This post hoc analysis of the randomized, multicenter P5 trial examined the efficacy of the cervical pessary associated with vaginal progesterone versus progesterone alone for preventing recurrent preterm birth in 155 pregnant women with cervical length \u226430 mm and prior spontaneous preterm birth (sPPTB) (main subgroup), and in 85 women with cervical length \u226425 mm and sPPTB (higher-risk population). The primary outcome was spontaneous preterm birth (sPTB) before 34 weeks; secondary outcomes included sPTB rates before 37, 32, and 28 weeks, analyzed using Odds Ratio (OR) and Kaplan\u2013Meier curves. A secondary objective was to identify predictive factors for sPTB recurrence in the cohort with prior preterm birth (n = 479), irrespective of treatment allocation. Results: Demographic profiles were balanced between groups. The addition of a cervical pessary to progesterone did not result in a significant reduction in sPTB before 34 weeks: to cervix \u226430 mm, OR 1.169 (95% CI 0.524\u20132.609; p = 0.703) and 1.167 (95% CI 0.466\u20132.921; p = 0.742) for \u226425 mm; similar null findings were observed across all gestational age thresholds. Kaplan\u2013Meier survival curves demonstrated no significant differences between groups (p &gt; 0.05). Secondary analysis (n = 479) identified principal predictors of sPTB recurrence, regardless of the cervical length: higher education (OR 2.37; 95% CI 0.99\u20135.63; p = 0.024), previous cervical conization (OR 4.78; 95% CI 1.08\u201321.19; p = 0.039) previous low birth weight &lt; 2.5 kg (OR 2.43; 95% CI 1.22\u20134.85; p = 0.051), prior miscarriages (OR 1.36; 95% CI 1.10\u20131.69; p = 0.005), current twin pregnancy (OR 14.86; 95% CI 4.35\u201350.68; p &lt; 0.001) and cervical funneling (OR 3.60; 95% CI 1.79\u20137.24; p &lt; 0.001). Predictive models achieved an AUC of 0.719, with 87.0% sensitivity and 58.8% specificity. Conclusions: These findings do not support the routine use of cervical pessary combined with progesterone in women with dual risk factors. In this Brazilian population, specific clinical and obstetric characteristics\u2014including higher education, cervical funneling, prior low birth weight delivery, previous conization, current twin gestation, and prior miscarriage\u2014could identify women at increased risk for recurrent preterm birth.<\/jats:p>","DOI":"10.3390\/diagnostics16030402","type":"journal-article","created":{"date-parts":[[2026,1,27]],"date-time":"2026-01-27T09:05:27Z","timestamp":1769504727000},"page":"402","update-policy":"https:\/\/doi.org\/10.3390\/mdpi_crossmark_policy","source":"Crossref","is-referenced-by-count":1,"title":["Efficacy of Combined Cervical Pessary and Progesterone in Women at High-Risk of Preterm Birth"],"prefix":"10.3390","volume":"16","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-5145-1061","authenticated-orcid":false,"given":"Marcelo Santucci","family":"Fran\u00e7a","sequence":"first","affiliation":[{"name":"Department of Obstetrics, Paulista School of Medicine-Federal University of S\u00e3o Paulo (EPM-UNIFESP), S\u00e3o Paulo 04023-062, SP, Brazil"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0009-0005-3126-891X","authenticated-orcid":false,"given":"Gabriela Ubeda Santucci","family":"Fran\u00e7a","sequence":"additional","affiliation":[{"name":"Department of Obstetrics, Paulista School of Medicine-Federal University of S\u00e3o Paulo (EPM-UNIFESP), S\u00e3o Paulo 04023-062, SP, Brazil"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-7306-533X","authenticated-orcid":false,"given":"Alan Roberto","family":"Hatanaka","sequence":"additional","affiliation":[{"name":"Department of Obstetrics, Paulista School of Medicine-Federal University of S\u00e3o Paulo (EPM-UNIFESP), S\u00e3o Paulo 04023-062, SP, Brazil"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-7882-1536","authenticated-orcid":false,"given":"Evelyn","family":"Traina","sequence":"additional","affiliation":[{"name":"Department of Obstetrics, Paulista School of Medicine-Federal University of S\u00e3o Paulo (EPM-UNIFESP), S\u00e3o Paulo 04023-062, SP, Brazil"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-2958-1921","authenticated-orcid":false,"given":"Tatiana Emy Kawanami","family":"Hamamoto","sequence":"additional","affiliation":[{"name":"Department of Obstetrics, Paulista School of Medicine-Federal University of S\u00e3o Paulo (EPM-UNIFESP), S\u00e3o Paulo 04023-062, SP, Brazil"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-4398-9141","authenticated-orcid":false,"given":"Danilo Brito","family":"Silva","sequence":"additional","affiliation":[{"name":"Department of Obstetrics, Paulista School of Medicine-Federal University of S\u00e3o Paulo (EPM-UNIFESP), S\u00e3o Paulo 04023-062, SP, Brazil"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-6145-2532","authenticated-orcid":false,"given":"Edward","family":"Araujo J\u00fanior","sequence":"additional","affiliation":[{"name":"Department of Obstetrics, Paulista School of Medicine-Federal University of S\u00e3o Paulo (EPM-UNIFESP), S\u00e3o Paulo 04023-062, SP, Brazil"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-1405-5371","authenticated-orcid":false,"given":"Rosiane","family":"Mattar","sequence":"additional","affiliation":[{"name":"Department of Obstetrics, Paulista School of Medicine-Federal University of S\u00e3o Paulo (EPM-UNIFESP), S\u00e3o Paulo 04023-062, SP, Brazil"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-2942-6182","authenticated-orcid":false,"given":"Antonio","family":"Braga","sequence":"additional","affiliation":[{"name":"Department of Gynecology and Obstetrics, School of Medicine, Federal University of Rio de Janeiro (UFRJ), Rio de Janeiro 22240-003, RJ, Brazil"},{"name":"Department of General and Specialized Surgery, School of Medicine and Surgery, Federal University of the State of Rio de Janeiro (UNIRIO), Rio de Janeiro 20271-062, RJ, Brazil"},{"name":"Postgraduate Program in Applied Health Sciences, University of Vassouras, Vassouras 27700-000, RJ, Brazil"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-5739-0009","authenticated-orcid":false,"given":"Rodolfo de Carvalho","family":"Pacagnella","sequence":"additional","affiliation":[{"name":"Department of Obstetrics and Gynecology, State University of Campinas (UNICAMP), Campinas 13083-859, SP, Brazil"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"1968","published-online":{"date-parts":[[2026,1,27]]},"reference":[{"key":"ref_1","doi-asserted-by":"crossref","first-page":"e37","DOI":"10.1016\/S2214-109X(18)30451-0","article-title":"Global, regional, and national estimates of levels of preterm birth in 2014: A systematic review and modelling analysis","volume":"7","author":"Chawanpaiboon","year":"2019","journal-title":"Lancet Glob. 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