Clinical Practice Evaluation of atosiban in preterm labour management in six European countries

Professor Peter Husslein
General Hospital, University of Vienna
Vienna, Austria

Biography
Professor Husslein was educated at the Medical School in Vienna, graduating in 1975. His thesis was awarded in 1985 and titled ‘The importance of oxytocin and prostaglandins for the mechanism of labour’. Professor Husslein became a Professor in Obstetrics and Gynaecology in 1992 and Chief of the Department of Obstetrics and Gynaecology at the University of Vienna. In 1996 he became Administrative Chief for the whole department of Obstetrics and Gynaecology.

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Abstract 
The objectives of this study were three fold: firstly, to compare the efficacy of atosiban with usual care in the management of threatened preterm labour, secondly, to evaluate the efficacy and safety of early administration compared with standard administration of atosiban and thirdly, to describe treatment administration patterns of tocolytics in usual care.

The study was designed as a prospective, open-label, randomised clinical trial divided into two parts. It was a multi-centre trial, which was performed in 105 centres in six European countries: Austria, France, Germany, Italy, Spain and the UK.

Women admitted to hospital in threatened preterm labour between 24 and 34 weeks’ gestation were included in the study. In the first part of the trial, women eligible to receive atosiban were randomised to receive atosiban or usual care (treatment with β-agonists, calcium channel blockers, magnesium sulphate, or any other tocolytic, alone or in combination, and/or bed rest). In the second part of the trial, women not fulfilling both specified criteria to receive atosiban were randomised to receive atosiban either immediately or when both criteria were met in order to evaluate early versus standard treatment. Efficacy was defined as the successful delay of delivery with no alternative tocolytic agent for 48 hours.

Eight-hundred-and-eleven women were recruited from 91 of the 105 centres. In the atosiban versus usual care study (n = 585), more women receiving atosiban remained undelivered at 48 hours with no alternative tocolytic compared with usual care (77.6% versus 56.6%; P < 0.001). Maternal and fetal safety was significantly superior with atosiban. Neonatal safety was comparable. In the early versus standard atosiban study (n = 226), more women in the early group remained undelivered at 48 hours with no alternative tocolytic (88.9% versus 76.1%; P = 0.03). Safety was comparable between groups.

Atosiban delayed delivery and reduced the need for an alternative tocolytic compared with usual care. Atosiban was associated with fewer maternal and fetal adverse events and presented no safety concerns irrespective of the time it was administered.

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