Pessary plus progesterone to prevent preterm birth in women with short cervixes. A randomized controlled trial

dc.contributor.authorPacagnella, Rodolfo de Carvalho
dc.contributor.authorSilva, Thais V.
dc.contributor.authorCecatti, José Guilherme
dc.contributor.authorPassini Jr., Renato
dc.contributor.authorFanton, Tatiana F.
dc.contributor.authorBorovac-Pinheiro, Anderson
dc.contributor.authorPereira, Cynara Maria
dc.contributor.authorFernandes, Karayna Gil
dc.contributor.authorFrança, Marcelo Santucci [UNIFESP]
dc.contributor.authorLi, Wentao
dc.contributor.authorMol, Ben W.
dc.contributor.authorP5 Working Group
dc.coverage.spatialEstados Unidos da Américapt_BR
dc.description.abstractOBJECTIVE: To test the effectiveness of cervical pessary in addition to vaginal progesterone for the prevention of preterm birth in women with midpregnancy short cervixes. METHODS: We performed a multicenter, open-label, randomized controlled trial in 17 perinatal centers. Asymptomatic women with singleton or twin pregnancies and cervical lengths of 30 mm or less, measured at 18 0/7– 22 6/7 weeks of gestation, were randomized to cervical pessary plus vaginal progesterone (pessary plus progesterone group) or vaginal progesterone only (progesteroneonly group) (200 mg/day). Treatments were used from randomization to 36 weeks of gestation or delivery. The primary outcome was a composite of neonatal mortality and morbidity. Secondary outcomes were delivery before 37 weeks and before 34 weeks of gestation. Analysis was performed according to intention to treat. RESULTS: Between July 9, 2015, and March 29, 2019, 8,168 women were screened, of whom 475 were randomized to pessary and 461 to progesterone only. The composite perinatal outcome occurred in 19.2% (89/463) of the women in the pessary group compared with 20.9% (91/436) of the women in the progesterone-only group (adjusted risk ratio [aRR] 0.88, 95% CI 0.69–1.12). Delivery rates before 37 weeks of gestation were 29.1% compared with 31.4% (aRR 0.86, 95% CI 0.72–1.04); delivery rates before 34 weeks were 9.9% compared with 13.9% (aRR 0.66, 95% CI 0.47–0.93). Women in the pessary group had more vaginal discharge (51.6% [245/476] vs 25.4% [117/479] [P,.001]), pain (33.1% [157/476] vs 24.1% [111/479] [P5.002]), and vaginal bleeding (9.7% [46/476] vs 4.8% [22/479] [P5.004]). CONCLUSION: In asymptomatic women with short cervixes, the combination of pessary and progesterone did not decrease rates of neonatal morbidity or mortality when compared with progesterone only.pt_BR
dc.description.sponsorshipConselho Nacional de Desenvolvimento Científico e Tecnológico (CNPq)pt_BR
dc.description.sponsorshipIDBill & Melinda Gates Foundation [OPP1107597], the Brazilian Ministry of Health, and the Brazilian National Council for Scientific and Technological Development (CNPq) [401615/20138].pt_BR
dc.format.extentp. 41-51pt_BR
dc.identifier.citationPacagnella RC, Silva TV, Cecatti JG, Passini R Jr, Fanton TF, Borovac-Pinheiro A, Pereira CM, Fernandes KG, França MS, Li W, Mol BW; P5 Working Group. Pessary plus progesterone to prevent preterm birth in women with short cervixes: A randomized controlled trial. Obstet Gynecol. 2022 Jan 1;139(1):p.41-51. doi: 10.1097/AOG.0000000000004634. PMID: 34856583.pt_BR
dc.publisherWolters Kluwer Health, Inc.pt_BR
dc.relation.ispartofObstetrics & Gynecologyen
dc.rightsAcesso abertopt_BR
dc.subjectCervical pessaryen
dc.subjectPreterm birthen
dc.subjectVaginal progesteroneen
dc.titlePessary plus progesterone to prevent preterm birth in women with short cervixes. A randomized controlled trialen
unifesp.campusEscola Paulista de Medicina (EPM)pt_BR
unifesp.graduateProgramMedicina (Obstetrícia)pt_BR
unifesp.knowledgeAreaMedicina fetalpt_BR
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