Atosiban Efficacy Assessment Survey in Europe – The German Data

This study was an open-label, randomised, prospective, multi-center, multi-country, survey study. The study included 811 pre-term labour patients. 201 patients were treated in Germany (atosiban: 119; fenoterol: 53; fenoterol + magnesium: 29). Inclusion criteria ≥ 18 years, gestational age between 24 and 33 completed weeks and signed informed consent obtained.Exclusion Criteria were antepartum uterine hemorrhage requiring immediate delivery, eclampsia and severe pre-eclampsia requiring delivery, intrauterine fetal death, placenta praevia, abruption placenta etc. Results: Primary endpoint:proportion of patients who remained undelivered and who did not receive alternative tocolytic within 48h from randomisation. Atosiban: 70.6% (84/119); fenoterol: 49.1% (26/53); fenoterol + magnesium: 51.7% (15/29).Maternal serious adverse events for atosiban 16.1% (19/118), fenoterol: 20.8% (44/53) and fenoterol + magnesium 24.1% (7/29). Fetal serious adverse events for atosiban 4.2% (5/118), fenoterol: 7.5% (4/53) and fenoterol + magnesium: 20.7% (6/29). Neonatal serious adverse events 28.8% (34/118), fenoterol: 37.7% (20/53) and fenoterol + magnesium: 31% (9/29).Conclusion: There was a higher success rate with atosiban versus usual care (fenoterol and fenoterol + magnesium) with regard to the primary endpoint. The higher success rate with atosiban is due to a better tolerability of atosiban as a higher proportion of women received alternative tocolytic within 48h after randomisation in usual care vs. atosiban.