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Multicentre, parallel group, randomised, single-blind study of the safety and efficacy of atosiban versus ritodrine in the treatment of acute preterm labour in Korean women

Cited 29 time in Web of Science Cited 32 time in Scopus
Authors
Shim, J-Y; Park, Y W; Yoon, B H; Cho, Y K; Yang, J-H; Lee, Y; Kim, A
Issue Date
2006-09-19
Publisher
Wiley-Blackwell
Citation
BJOG. 2006 Nov;113(11):1228-34. Epub 2006 Sep 15.
Keywords
Acute DiseaseAdultFemaleGestational AgeHumansMaternal AgeObstetric Labor, Premature/*prevention & controlPregnancyRitodrine/*therapeutic useSingle-Blind MethodTocolytic Agents/*therapeutic useTreatment OutcomeVasotocin/*analogs & derivatives/therapeutic use
Abstract
OBJECTIVE: To compare the efficacy and safety of atosiban with those of ritodrine in preterm labour. DESIGN: Multicentre, single-blind, randomised, controlled trial. SETTING: Obstetric units in six referral centres in Korea. POPULATION: Women with singleton pregnancies with preterm labour, between 24 and 33 + 6 weeks of gestation. METHODS: One hundred and twenty-eight women were randomised to receive intravenous atosiban (n= 63) or ritodrine (n= 65) and were stratified by gestational age (<28 weeks and >or=28 weeks). Atosiban or ritodrine was administered for up to 48 hours. Progression of labour was assessed by the frequency of contractions and cervical dilatation and effacement. Alternative tocolysis could be given as rescue therapy. MAIN OUTCOME MEASURE: Efficacy was assessed as the proportion of women in each group who did not deliver and did not need alternative tocolytic therapy at 48 hours and 7 days after therapy initiation. Safety was assessed as the numbers of maternal adverse events and neonatal morbidity. RESULTS: Tocolytic efficacy after 7 days was significantly better in the atosiban group than in the ritodrine group (60.3 versus 34.9%), but not at 48 hours (68.3 versus 58.7%). Maternal adverse events related to therapy were reported less frequently in the atosiban group (7.9 vs 70.8%; P= 0.0001), resulting in fewer early drug terminations due to adverse events (0 versus 20.0%; P= 0.0001). This, however, was not accompanied by a concurrent improvement in perinatal outcomes. CONCLUSION: The efficacy and safety of atosiban in the treatment of preterm labour were superior to those of ritodrine.
ISSN
1470-0328 (Print)
Language
English
URI
http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&dopt=Citation&list_uids=16978233

http://hdl.handle.net/10371/14912
DOI
https://doi.org/10.1111/j.1471-0528.2006.01053.x
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College of Medicine/School of Medicine (의과대학/대학원)Obstetrics & Gynecology (산부인과전공)Journal Papers (저널논문_산부인과학전공)
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