Clinical practice evaluation of atosiban in preterm labour management in six European countries.
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.
Husslein
P
P
Department of Obstetrics and Gynaecology, University of Vienna, General Hospital, Vienna, Austria.
Roura
L C
LC
Dudenhausen
J
J
Helmer
H
H
Frydman
R
R
Rizzo
N
N
Schneider
D
D
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
D015149:Tocolytic Agents; C047046:atosiban; D014668:Vasotocin