Assessment of perinatal outcome after sustained tocolysis in early labour (APOSTEL-II trial).
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.
Roos
Carolien
C
Department of Obstetrics and Gynaecology, Radboud University Nijmegen Medical Centre, Nijmegen, The Netherlands. C.Roos@obgyn.umcn.nl
Scheepers
Liesbeth Hcj
LH
Bloemenkamp
Kitty Wm
KW
Bolte
Annemiek
A
Cornette
Jerome
J
Derks
Jan B
JB
Duvekot
Hans Jj
HJ
van Eyck
Jim
J
Kok
Joke H
JH
Kwee
Anneke
A
Merién
Ashley
A
Opmeer
Brent C
BC
van Pampus
Mariëlle G
MG
Papatsonis
Dimitri Nm
DN
Porath
Martina M
MM
van der Post
Joris Am
JA
Scherjon
Sicco A
SA
Sollie
Krystyne
K
Spaanderman
Marc Ea
ME
Vijgen
Sylvia Mc
SM
Willekes
Christine
C
Mol
Ben Willem J
BW
Lotgering
Fred K
FK
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*
D005353:Fibronectins; D015149:Tocolytic Agents; D009543:Nifedipine