PMID- 17206976 OWN - NLM STAT- MEDLINE DCOM- 20070424 LR - 20141120 IS - 1470-0328 (Print) IS - 1470-0328 (Linking) VI - 113 Suppl 3 DP - 2006 Dec TI - Clinical practice evaluation of atosiban in preterm labour management in six European countries. PG - 105-10 AB - OBJECTIVE: To evaluate the efficacy and safety of early administration compared with standard administration of atosiban, when predefined eligibility criteria were met. DESIGN: 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). SETTING: Carried out at 105 centres in six European countries. POPULATION: 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. MAIN OUTCOME MEASURES: 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. FAU - Husslein, P AU - Husslein P AD - Department of Obstetrics and Gynaecology, University of Vienna, General Hospital, Vienna, Austria. FAU - Roura, L C AU - Roura LC FAU - Dudenhausen, J AU - Dudenhausen J FAU - Helmer, H AU - Helmer H FAU - Frydman, R AU - Frydman R FAU - Rizzo, N AU - Rizzo N FAU - Schneider, D AU - Schneider D CN - TREASURE study group LA - eng PT - Journal Article PT - Multicenter Study PT - Randomized Controlled Trial PT - Research Support, Non-U.S. Gov't PL - England TA - BJOG JT - BJOG : an international journal of obstetrics and gynaecology JID - 100935741 RN - 0 (Tocolytic Agents) RN - 081D12SI0Z (atosiban) RN - W6S6URY8OF (Vasotocin) SB - IM EIN - BJOG. 2008 Apr;115(5):674-5 MH - Adolescent MH - Adult MH - Europe MH - Female MH - Humans MH - Labor Stage, First/drug effects MH - Obstetric Labor, Premature/*drug therapy MH - Pregnancy MH - Prospective Studies MH - Tocolytic Agents/adverse effects/*therapeutic use MH - Uterine Contraction/drug effects MH - Vasotocin/adverse effects/*analogs & derivatives/therapeutic use EDAT- 2007/01/09 09:00 MHDA- 2008/03/26 09:00 CRDT- 2007/01/09 09:00 PHST- 2007/01/09 09:00 [pubmed] PHST- 2008/03/26 09:00 [medline] PHST- 2007/01/09 09:00 [entrez] AID - BJO1134 [pii] AID - 10.1111/j.1471-0528.2006.01134.x [doi] PST - ppublish SO - BJOG. 2006 Dec;113 Suppl 3:105-10. doi: 10.1111/j.1471-0528.2006.01134.x.