title: Cervical pessary to prevent preterm birth in women with twin gestation and sonographic short cervix: a multicenter randomized controlled trial (PECEP-Twins).
abstract: BACKGROUND
  Spontaneous preterm birth (SPB) is the leading cause of perinatal morbidity and mortality. In twins, the rate of preterm birth is higher than in singletons; interventions to prevent preterm birth are needed in this high-risk population.
  
  
  OBJECTIVE
  We sought to test whether a cervical pessary reduces the preterm birth rate in twin pregnancies with sonographic short cervix.
  
  
  METHODS
  A prospective, open-label, multicenter, randomized clinical trial was conducted in 5 hospitals in Spain. The ethics committees of all participating hospitals approved the protocol. The trial was registered as ClinicalTrials.gov, number NCT01242410. Eligible women were scanned in Spain. The primary outcome was SPB <34 weeks of gestation. Neonatal morbidity and mortality were also evaluated.
  
  
  RESULTS
  Cervical length was measured in 2287 women; 137 pregnant women with a sonographic cervical length ≤25 mm (of 154 detected with a short cervix) were randomly assigned to receive a cervical pessary or expectant management (1:1 ratio). SPB <34 weeks of gestation was significantly less frequent in the pessary group than in the expectant management group (11/68 [16.2%] vs 26/66 [39.4%]; relative risk, 0.41; 95% confidence interval, 0.22-0.76). Pessary use was associated with a significant reduction in the rate of birthweight <2500 g (P = .01). No significant differences were observed in composite neonatal morbidity outcome (8/136 [5.9%] vs 12/130 [9.1%]; relative risk, 0.64; 95% confidence interval, 0.27-1.50) or neonatal mortality (none) between the groups. No serious adverse effects associated with the use of a cervical pessary were observed.
  
  
  CONCLUSIONS
  The insertion of a cervical pessary was associated with a significant reduction in the SPB rate. We propose the use of a cervical pessary for preventing preterm birth in twin pregnancies of mothers with a short cervix.
authors.affiliation: Maternal Fetal Medicine Units, Department of Obstetrics at Hospital Universitari Vall d'Hebron, Universitat Autonoma de Barcelona, Barcelona. Electronic address: mgoya@vhebron.net.
authors.forename: Maria
authors.initials: M
authors.lastname: Goya
authors.affiliation: Hospital Materno Infantil La Paz, Madrid.
authors.forename: Maria
authors.initials: M
authors.lastname: de la Calle
authors.affiliation: Maternal Fetal Medicine Units, Department of Obstetrics at Hospital Universitari Vall d'Hebron, Universitat Autonoma de Barcelona, Barcelona.
authors.forename: Laia
authors.initials: L
authors.lastname: Pratcorona
authors.affiliation: Maternal Fetal Medicine Units, Department of Obstetrics at Hospital Universitari Vall d'Hebron, Universitat Autonoma de Barcelona, Barcelona.
authors.forename: Carme
authors.initials: C
authors.lastname: Merced
authors.affiliation: Maternal Fetal Medicine Units, Department of Obstetrics at Hospital Universitari Vall d'Hebron, Universitat Autonoma de Barcelona, Barcelona.
authors.forename: Carlota
authors.initials: C
authors.lastname: Rodó
authors.affiliation: Hospital Sant Joan de Reus, Reus, Tarragona.
authors.forename: Begoña
authors.initials: B
authors.lastname: Muñoz
authors.affiliation: Hospital Son Llatzer, Balearic Islands.
authors.forename: Miquel
authors.initials: M
authors.lastname: Juan
authors.affiliation: Institut Sanitari Dexeus. Barcelona.
authors.forename: Ariana
authors.initials: A
authors.lastname: Serrano
authors.affiliation: Maternal Fetal Medicine Units, Department of Obstetrics at Hospital Universitari Vall d'Hebron, Universitat Autonoma de Barcelona, Barcelona.
authors.forename: Elisa
authors.initials: E
authors.lastname: Llurba
authors.affiliation: Maternal Fetal Medicine Units, Department of Obstetrics at Hospital Universitari Vall d'Hebron, Universitat Autonoma de Barcelona, Barcelona.
authors.forename: Teresa
authors.initials: T
authors.lastname: Higueras
authors.affiliation: Maternal Fetal Medicine Units, Department of Obstetrics at Hospital Universitari Vall d'Hebron, Universitat Autonoma de Barcelona, Barcelona.
authors.forename: Elena
authors.initials: E
authors.lastname: Carreras
authors.affiliation: Maternal Fetal Medicine Units, Department of Obstetrics at Hospital Universitari Vall d'Hebron, Universitat Autonoma de Barcelona, Barcelona.
authors.forename: Luis
authors.initials: L
authors.lastname: Cabero
mesh_terms: D000328:Adult; D054791:Cervical Length Measurement; D002584:Cervix Uteri / Q000000981:diagnostic imaging*; D002821:Chorioamnionitis / Q000453:epidemiology*; D005260:Female; D005322:Premature Rupture of Fetal Membranes / Q000453:epidemiology*; D006760:Hospitalization / Q000706:statistics & numerical data; D006801:Humans; D007230:Infant, Low Birth Weight; D007231:Infant, Newborn; D007902:Length of Stay; D010570:Pessaries; D011247:Pregnancy; D059285:Pregnancy, Twin; D047928:Premature Birth / Q000517:prevention & control*; D013030:Spain; D015145:Tocolysis / Q000706:statistics & numerical data*; D016896:Treatment Outcome
keywords: cervical length; neonatal morbidity and mortality; prematurity; preterm birth; short cervix; twins