title: Evaluation of two treatment strategies for the prevention of preterm birth in women identified as at risk by ultrasound (PESAPRO Trial): study protocol for a randomized controlled trial.
abstract: BACKGROUND
  Premature birth is considered one of the main problems in modern Obstetrics. It causes more than 50 % of neonatal mortality; it is responsible for a large proportion of infant morbidity and incurs very high economic costs. Cervical length, which can be accurately measured by ultrasound, has an inverse relationship with the risk of preterm birth. As a result, having an effective intervention for asymptomatic patients with short cervix could reduce the prematurity. Although recently published data demonstrates the effectiveness of vaginal progesterone and cervical pessary, these treatments have never been compared to one another.
  
  
  METHODS
  The PESAPRO study is a noncommercial, multicenter, open-label, randomized clinical trial (RCT) in pregnant women with a short cervix as identified by transvaginal ultrasonography at 19 to 22 weeks of gestation. Patients are randomized (1:1) to either daily vaginal progesterone or cervical pessary until the 37th week of gestation or delivery; whichever comes first. During the trial, women visit every 4 weeks for routine questions and tests. The primary outcome is the proportion of spontaneous preterm deliveries before 34 weeks of gestation. A sample size of 254 pregnant women will be included at 29 participating hospitals in order to demonstrate noninferiority of placing a pessary versus vaginal progesterone. The first patient was randomized in August 2012, and recruitment of study subjects will continue until the end of December 2015.
  
  
  CONCLUSIONS
  This trial assesses the comparative efficacy and safety between two accepted treatments, cervical pessary versus vaginal progesterone, and it will provide evidence in order to establish clinical recommendations.
  
  
  BACKGROUND
  EU Clinical Trials Register EudraCT2012-000241-13 (Date of registration: 16 January 2012); ClinicalTrials.gov Identifier NCT01643980 (Date of registration: 12 June 2012).
authors.affiliation: Clinical Pharmacology Service, University Hospital Puerta de Hierro - Majadahonda, Manuel de Falla, 1, 28222, Majadahonda, Madrid, Spain. lcabreragarcia@gmail.com.
authors.forename: Lourdes
authors.initials: L
authors.lastname: Cabrera-García
authors.affiliation: Obstetrics and Gynecology Department, University Hospital Puerta de Hierro - Majadahonda, Manuel de Falla, 1, 28222, Majadahonda, Madrid, Spain. saracruz.gine@yahoo.es.
authors.forename: Sara
authors.initials: S
authors.lastname: Cruz-Melguizo
authors.affiliation: Clinical Pharmacology Service, University Hospital Puerta de Hierro - Majadahonda, Manuel de Falla, 1, 28222, Majadahonda, Madrid, Spain. mariabelen.ruiz@salud.madrid.org.
authors.forename: Belén
authors.initials: B
authors.lastname: Ruiz-Antorán
authors.affiliation: Biostatistics and Data Management Core Facility, IDIBAPS - Hospital Clínic, 183, Mallorca Street, floor -1, 08036, Barcelona, Spain. Ferran.Torres@uab.cat.
authors.forename: Ferrán
authors.initials: F
authors.lastname: Torres
authors.affiliation: Spanish Clinical Research Network, SCReN-IIS Puerta de Hierro Majadahonda, University Hospital Puerta de Hierro Majadahonda, Manuel de Falla, 1, 28222, Majadahonda, Madrid, Spain. avelascoi@salud.madrid.org.
authors.forename: Ana
authors.initials: A
authors.lastname: Velasco
authors.affiliation: Obstetrics and Gynecology Department, University Hospital Puerta de Hierro - Majadahonda, Manuel de Falla, 1, 28222, Majadahonda, Madrid, Spain. cmartinezpy@gmail.com.
authors.forename: Cristina
authors.initials: C
authors.lastname: Martínez-Payo
authors.affiliation: Clinical Pharmacology Service, University Hospital Puerta de Hierro - Majadahonda, Manuel de Falla, 1, 28222, Majadahonda, Madrid, Spain. cavendanosola@gmail.com.
authors.forename: Cristina
authors.initials: C
authors.lastname: Avendaño-Solá
mesh_terms: D000282:Administration, Intravaginal; D002584:Cervix Uteri / Q000000981:diagnostic imaging* / Q000187:drug effects*; D002985:Clinical Protocols; D005260:Female; D005865:Gestational Age; D006801:Humans; D010570:Pessaries; D011237:Predictive Value of Tests; D011247:Pregnancy; D047928:Premature Birth / Q000209:etiology / Q000517:prevention & control*; D011374:Progesterone / Q000008:administration & dosage* / Q000009:adverse effects; D011372:Progestins / Q000008:administration & dosage* / Q000009:adverse effects; D012107:Research Design; D018570:Risk Assessment; D012307:Risk Factors; D013030:Spain; D013997:Time Factors; D016896:Treatment Outcome; D016216:Ultrasonography, Prenatal
chemical_list: D011372:Progestins; D011374:Progesterone