title: A Randomized Trial of a Cervical Pessary to Prevent Preterm Singleton Birth.
abstract: BACKGROUND
  Preterm birth is the leading cause of neonatal and infant death and of disability among survivors. It is unclear whether a pessary inserted around the cervix reduces the risk of preterm singleton birth.
  
  
  METHODS
  We conducted a multicenter, randomized, controlled trial comparing pessary placement with expectant management (control) in girls and women who were pregnant with singletons (singleton pregnancies) and who had a cervical length of 25 mm or less at 20 weeks 0 days to 24 weeks 6 days of gestation. Participants in either group who had a cervical length of 15 mm or less, at randomization or at subsequent visits, received treatment with vaginal progesterone. The primary outcome was spontaneous delivery before 34 weeks of gestation.
  
  
  RESULTS
  In an intention-to-treat analysis, there was no significant difference between the pessary group (465 participants) and the control group (467 participants) in the rate of spontaneous delivery before 34 weeks (12.0% and 10.8%, respectively; odds ratio in the pessary group, 1.12; 95% confidence interval, 0.75 to 1.69; P=0.57). There were no significant differences in the rates of perinatal death (3.2% in the pessary group and 2.4% in the control group, P=0.42), adverse neonatal outcome (6.7% and 5.7%, respectively; P=0.55), or neonatal special care (11.6% and 12.9%, respectively; P=0.59). The incidence of new or increased vaginal discharge was significantly higher in the pessary group than in the control group.
  
  
  CONCLUSIONS
  Among girls and women with singleton pregnancies who had a short cervix, a cervical pessary did not result in a lower rate of spontaneous early preterm delivery than the rate with expectant management. (Funded by the Fetal Medicine Foundation; Current Controlled Trials number, ISRCTN01096902.).
authors.affiliation: From the Harris Birthright Research Center for Fetal Medicine, King's College, London (K.H.N., A.S., L.C.P., A.Z., E.S., J.R.C.), and the Department of Fetal Medicine, Medway Maritime Hospital, Gillingham (G.P.) - both in the United Kingdom; Department of Perinatology, University Medical Center Ljubljana, Slovenia (N.T.); Fetal Medicine Unit, Hospital Clinico Universidad de Chile, Santiago, Chile (M.P.-C.); and Pregnancy Research Center, Royal Women's Hospital, Melbourne, VIC, Australia. (R.P.-D.).
authors.forename: Kypros H
authors.initials: KH
authors.lastname: Nicolaides
authors.affiliation: From the Harris Birthright Research Center for Fetal Medicine, King's College, London (K.H.N., A.S., L.C.P., A.Z., E.S., J.R.C.), and the Department of Fetal Medicine, Medway Maritime Hospital, Gillingham (G.P.) - both in the United Kingdom; Department of Perinatology, University Medical Center Ljubljana, Slovenia (N.T.); Fetal Medicine Unit, Hospital Clinico Universidad de Chile, Santiago, Chile (M.P.-C.); and Pregnancy Research Center, Royal Women's Hospital, Melbourne, VIC, Australia. (R.P.-D.).
authors.forename: Argyro
authors.initials: A
authors.lastname: Syngelaki
authors.affiliation: From the Harris Birthright Research Center for Fetal Medicine, King's College, London (K.H.N., A.S., L.C.P., A.Z., E.S., J.R.C.), and the Department of Fetal Medicine, Medway Maritime Hospital, Gillingham (G.P.) - both in the United Kingdom; Department of Perinatology, University Medical Center Ljubljana, Slovenia (N.T.); Fetal Medicine Unit, Hospital Clinico Universidad de Chile, Santiago, Chile (M.P.-C.); and Pregnancy Research Center, Royal Women's Hospital, Melbourne, VIC, Australia. (R.P.-D.).
authors.forename: Liona C
authors.initials: LC
authors.lastname: Poon
authors.affiliation: From the Harris Birthright Research Center for Fetal Medicine, King's College, London (K.H.N., A.S., L.C.P., A.Z., E.S., J.R.C.), and the Department of Fetal Medicine, Medway Maritime Hospital, Gillingham (G.P.) - both in the United Kingdom; Department of Perinatology, University Medical Center Ljubljana, Slovenia (N.T.); Fetal Medicine Unit, Hospital Clinico Universidad de Chile, Santiago, Chile (M.P.-C.); and Pregnancy Research Center, Royal Women's Hospital, Melbourne, VIC, Australia. (R.P.-D.).
authors.forename: Gemma
authors.initials: G
authors.lastname: Picciarelli
authors.affiliation: From the Harris Birthright Research Center for Fetal Medicine, King's College, London (K.H.N., A.S., L.C.P., A.Z., E.S., J.R.C.), and the Department of Fetal Medicine, Medway Maritime Hospital, Gillingham (G.P.) - both in the United Kingdom; Department of Perinatology, University Medical Center Ljubljana, Slovenia (N.T.); Fetal Medicine Unit, Hospital Clinico Universidad de Chile, Santiago, Chile (M.P.-C.); and Pregnancy Research Center, Royal Women's Hospital, Melbourne, VIC, Australia. (R.P.-D.).
authors.forename: Natasa
authors.initials: N
authors.lastname: Tul
authors.affiliation: From the Harris Birthright Research Center for Fetal Medicine, King's College, London (K.H.N., A.S., L.C.P., A.Z., E.S., J.R.C.), and the Department of Fetal Medicine, Medway Maritime Hospital, Gillingham (G.P.) - both in the United Kingdom; Department of Perinatology, University Medical Center Ljubljana, Slovenia (N.T.); Fetal Medicine Unit, Hospital Clinico Universidad de Chile, Santiago, Chile (M.P.-C.); and Pregnancy Research Center, Royal Women's Hospital, Melbourne, VIC, Australia. (R.P.-D.).
authors.forename: Aikaterini
authors.initials: A
authors.lastname: Zamprakou
authors.affiliation: From the Harris Birthright Research Center for Fetal Medicine, King's College, London (K.H.N., A.S., L.C.P., A.Z., E.S., J.R.C.), and the Department of Fetal Medicine, Medway Maritime Hospital, Gillingham (G.P.) - both in the United Kingdom; Department of Perinatology, University Medical Center Ljubljana, Slovenia (N.T.); Fetal Medicine Unit, Hospital Clinico Universidad de Chile, Santiago, Chile (M.P.-C.); and Pregnancy Research Center, Royal Women's Hospital, Melbourne, VIC, Australia. (R.P.-D.).
authors.forename: Evdoxia
authors.initials: E
authors.lastname: Skyfta
authors.affiliation: From the Harris Birthright Research Center for Fetal Medicine, King's College, London (K.H.N., A.S., L.C.P., A.Z., E.S., J.R.C.), and the Department of Fetal Medicine, Medway Maritime Hospital, Gillingham (G.P.) - both in the United Kingdom; Department of Perinatology, University Medical Center Ljubljana, Slovenia (N.T.); Fetal Medicine Unit, Hospital Clinico Universidad de Chile, Santiago, Chile (M.P.-C.); and Pregnancy Research Center, Royal Women's Hospital, Melbourne, VIC, Australia. (R.P.-D.).
authors.forename: Mauro
authors.initials: M
authors.lastname: Parra-Cordero
authors.affiliation: From the Harris Birthright Research Center for Fetal Medicine, King's College, London (K.H.N., A.S., L.C.P., A.Z., E.S., J.R.C.), and the Department of Fetal Medicine, Medway Maritime Hospital, Gillingham (G.P.) - both in the United Kingdom; Department of Perinatology, University Medical Center Ljubljana, Slovenia (N.T.); Fetal Medicine Unit, Hospital Clinico Universidad de Chile, Santiago, Chile (M.P.-C.); and Pregnancy Research Center, Royal Women's Hospital, Melbourne, VIC, Australia. (R.P.-D.).
authors.forename: Ricardo
authors.initials: R
authors.lastname: Palma-Dias
authors.affiliation: From the Harris Birthright Research Center for Fetal Medicine, King's College, London (K.H.N., A.S., L.C.P., A.Z., E.S., J.R.C.), and the Department of Fetal Medicine, Medway Maritime Hospital, Gillingham (G.P.) - both in the United Kingdom; Department of Perinatology, University Medical Center Ljubljana, Slovenia (N.T.); Fetal Medicine Unit, Hospital Clinico Universidad de Chile, Santiago, Chile (M.P.-C.); and Pregnancy Research Center, Royal Women's Hospital, Melbourne, VIC, Australia. (R.P.-D.).
authors.forename: Jesus
authors.initials: J
authors.lastname: Rodriguez Calvo
mesh_terms: D000293:Adolescent; D000328:Adult; D002584:Cervix Uteri / Q000033:anatomy & histology; D005260:Female; D005865:Gestational Age; D006801:Humans; D007231:Infant, Newborn; D007234:Infant, Premature; D007235:Infant, Premature, Diseases / Q000453:epidemiology; D057194:Intention to Treat Analysis; D053208:Kaplan-Meier Estimate; D066087:Perinatal Death; D010570:Pessaries; D011247:Pregnancy; D047928:Premature Birth / Q000517:prevention & control*; D017211:Treatment Failure; D055815:Young Adult