title: Clinical practice evaluation of atosiban in preterm labour management in six European countries.
abstract: OBJECTIVE
  To evaluate the efficacy and safety of early administration compared with standard administration of atosiban, when predefined eligibility criteria were met.
  
  
  METHODS
  A prospective, open-label, randomised clinical trial. Women were randomised to receive atosiban either immediately (early) or when specified criteria, in terms of duration/frequency of uterine contraction or status of cervical dilation/effacement, were fulfilled (standard).
  
  
  METHODS
  Carried out at 105 centres in six European countries.
  
  
  METHODS
  Pregnant women admitted to hospital in threatened preterm labour between 24 and 34 weeks of gestation, comprising a subgroup of women enrolled in the Tractocile Efficacy Assessment Survey in Europe (TREASURE) clinical experience review.
  
  
  METHODS
  Efficacy was defined as the successful delay of delivery with no alternative tocolytic agent for 48 hours.
  
  
  RESULTS
  More women in the early group remained undelivered at 48 hours with no alternative tocolytic agent compared with those who received atosiban when specified criteria were fulfilled (88.9 versus 76.1%; P = 0.03). Safety was comparable between the groups. There were no statistical differences in maternal, fetal or neonatal adverse events between the early and standard atosiban arms.
  
  
  CONCLUSIONS
  The use of atosiban was effective for the delay of preterm labour and presented no safety concerns irrespective of the time it was administered.
authors.affiliation: Department of Obstetrics and Gynaecology, University of Vienna, General Hospital, Vienna, Austria.
authors.forename: P
authors.initials: P
authors.lastname: Husslein
authors.forename: L C
authors.initials: LC
authors.lastname: Roura
authors.forename: J
authors.initials: J
authors.lastname: Dudenhausen
authors.forename: H
authors.initials: H
authors.lastname: Helmer
authors.forename: R
authors.initials: R
authors.lastname: Frydman
authors.forename: N
authors.initials: N
authors.lastname: Rizzo
authors.forename: D
authors.initials: D
authors.lastname: Schneider
mesh_terms: D000293:Adolescent; D000328:Adult; D005060:Europe; D005260:Female; D006801:Humans; D007747:Labor Stage, First / Q000187:drug effects; D007752:Obstetric Labor, Premature / Q000188:drug therapy*; D011247:Pregnancy; D011446:Prospective Studies; D015149:Tocolytic Agents / Q000009:adverse effects / Q000627:therapeutic use*; D014590:Uterine Contraction / Q000187:drug effects; D014668:Vasotocin / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use
chemical_list: D015149:Tocolytic Agents; C047046:atosiban; D014668:Vasotocin