title: Assessment of perinatal outcome after sustained tocolysis in early labour (APOSTEL-II trial).
abstract: BACKGROUND
  Preterm labour is the main cause of perinatal morbidity and mortality in the Western world. At present, there is evidence that tocolysis for 48 hours is useful in women with threatened preterm labour at least before 32 weeks. This allows transfer of the patient to a perinatal centre, and maximizes the effect of corticosteroids for improved neonatal survival. It is questionable whether treatment with tocolytics should be maintained after 48 hours.
  
  
  METHODS
  The APOSTEL II trial is a multicentre placebo-controlled study. Pregnant women admitted for threatened preterm labour who have been treated with 48 hours corticosteroids and tocolysis will be eligible to participate in the trial between 26+0 and 32+2 weeks gestational age. They will be randomly allocated to nifedipine (intervention) or placebo (control) for twelve days or until delivery, whatever comes first.Primary outcome is a composite of perinatal death, and severe neonatal morbidity up to evaluation at 6 months after birth. Secondary outcomes are gestational age at delivery, number of days in neonatal intensive care and total days of the first 6 months out of hospital. In addition a cost-effectiveness analysis will be performed. Analysis will be by intention to treat. The power calculation is based on an expected 11% difference in adverse neonatal outcome. This implies that 406 women have to be randomised (two sided test, beta 0.2 at alpha 0.05).
  
  
  CONCLUSIONS
  This trial will provide evidence as to whether maintenance tocolysis reduces severe perinatal morbidity and mortality in women with threatened preterm labour before 32 weeks.
  
  
  BACKGROUND
  
  
  
  BACKGROUND
  http://www.trialregister.nl, NTR 1336, date of registration: June 3rd 2008.
authors.affiliation: Department of Obstetrics and Gynaecology, Radboud University Nijmegen Medical Centre, Nijmegen, The Netherlands. C.Roos@obgyn.umcn.nl
authors.forename: Carolien
authors.initials: C
authors.lastname: Roos
authors.forename: Liesbeth Hcj
authors.initials: LH
authors.lastname: Scheepers
authors.forename: Kitty Wm
authors.initials: KW
authors.lastname: Bloemenkamp
authors.forename: Annemiek
authors.initials: A
authors.lastname: Bolte
authors.forename: Jerome
authors.initials: J
authors.lastname: Cornette
authors.forename: Jan B
authors.initials: JB
authors.lastname: Derks
authors.forename: Hans Jj
authors.initials: HJ
authors.lastname: Duvekot
authors.forename: Jim
authors.initials: J
authors.lastname: van Eyck
authors.forename: Joke H
authors.initials: JH
authors.lastname: Kok
authors.forename: Anneke
authors.initials: A
authors.lastname: Kwee
authors.forename: Ashley
authors.initials: A
authors.lastname: Merién
authors.forename: Brent C
authors.initials: BC
authors.lastname: Opmeer
authors.forename: Mariëlle G
authors.initials: MG
authors.lastname: van Pampus
authors.forename: Dimitri Nm
authors.initials: DN
authors.lastname: Papatsonis
authors.forename: Martina M
authors.initials: MM
authors.lastname: Porath
authors.forename: Joris Am
authors.initials: JA
authors.lastname: van der Post
authors.forename: Sicco A
authors.initials: SA
authors.lastname: Scherjon
authors.forename: Krystyne
authors.initials: K
authors.lastname: Sollie
authors.forename: Marc Ea
authors.initials: ME
authors.lastname: Spaanderman
authors.forename: Sylvia Mc
authors.initials: SM
authors.lastname: Vijgen
authors.forename: Christine
authors.initials: C
authors.lastname: Willekes
authors.forename: Ben Willem J
authors.initials: BW
authors.lastname: Mol
authors.forename: Fred K
authors.initials: FK
authors.lastname: Lotgering
mesh_terms: D054791:Cervical Length Measurement; D002985:Clinical Protocols; D004334:Drug Administration Schedule; D005260:Female; D005353:Fibronectins / Q000378:metabolism; D005865:Gestational Age; D006801:Humans; D007231:Infant, Newborn; D009543:Nifedipine / Q000008:administration & dosage*; D007752:Obstetric Labor, Premature / Q000517:prevention & control*; D017063:Outcome Assessment, Health Care; D011247:Pregnancy; D012107:Research Design; D015145:Tocolysis / Q000379:methods*; D015149:Tocolytic Agents / Q000008:administration & dosage*
chemical_list: D005353:Fibronectins; D015149:Tocolytic Agents; D009543:Nifedipine