Effectiveness and safety of the oxytocin antagonist atosiban versus beta-adrenergic agonists in the treatment of preterm labour

Moutquin, J.M., Cabrol, D., Fisk, N.M., MacLennan, A.H., Marsal, K., Rabinovici, J. and Worldwide Atosiban versus Beta-a (2001) Effectiveness and safety of the oxytocin antagonist atosiban versus beta-adrenergic agonists in the treatment of preterm labour. British Journal of Obstetrics and Gynaecology, 108 2: 133-142. doi:10.1016/S0306-5456(00)00043-7


Author Moutquin, J.M.
Cabrol, D.
Fisk, N.M.
MacLennan, A.H.
Marsal, K.
Rabinovici, J.
Worldwide Atosiban versus Beta-a
Title Effectiveness and safety of the oxytocin antagonist atosiban versus beta-adrenergic agonists in the treatment of preterm labour
Journal name British Journal of Obstetrics and Gynaecology   Check publisher's open access policy
ISSN 0306-5456
1365-215X
Publication date 2001-02-01
Year available 2001
Sub-type Article (original research)
DOI 10.1016/S0306-5456(00)00043-7
Open Access Status Not yet assessed
Volume 108
Issue 2
Start page 133
End page 142
Total pages 10
Place of publication West Sussex, United Kingdom
Publisher Wiley-Blackwell Publishing
Language eng
Abstract Objective To compare the effectiveness and safety of the oxytocin antagonist atosiban with conventional beta-adrenergic agonist (beta-agonist) therapy in the treatment of preterm labour.
Formatted abstract
Objective:
To compare the effectiveness and safety of the oxytocin antagonist atosiban with conventional beta-adrenergic agonist (beta-agonist) therapy in the treatment of preterm labour. Design: Three multinational, multicentre, double-blind, randomised, controlled trials. Setting: Hospitals in Australia, Canada, Czech Republic, Denmark, France, Israel, Sweden, and the UK. Population: Women diagnosed with preterm labour at 23-33 completed weeks of gestation.

Methods:
Seven hundred and forty-two women were randomised; 733 received atosiban (n = 363; intravenous (iv) bolus dose of 6.75 mg, then 300 μg/minute iv. for 3h and 100 μg/min iv thereafter) or beta-agonist (n = 379; ritodrine, salbutamol or terbutaline iv; dose titrated) for at least 18h and up to 48 hours. Uterine contraction rate, cervical dilatation and effacement were used to assess progression of labour. An all patients treated analysis, using the Cochran-Mantel-Haenszel test, was performed. Main outcome measures: Tocolytic effectiveness was assessed in terms of the number of women undelivered after 48 hours and seven days. Safety was assessed in terms of maternal side effects and neonatal morbidity.

Results:
There were no significant differences between atosiban and β-agonists in delaying delivery for 48h (88.1% vs 88.9%; P = 0.99) or seven days (79.7% versus 77.6%; P = 0.28). Tocolytic effectiveness was also similar in terms of mean [SD] gestational age at delivery (35.8 [3.9] weeks vs 35.5 [4.1] weeks) and mean [SD] birthweight (2491 [813] g versus 2461 [831] g). Maternal side effects, particularly cardiovascular adverse events (8.3% vs 81.2%, P < 0.001), were reported more frequently in women given β-agonists, resulting in more treatment discontinuations due to side effects (1.1% vs 15.4%, P = 0.0001). No statistical differences in neonatal/infant outcomes were observed with either study medication.

Conclusions:
In the largest study of tocolytic therapy to date, atosiban was comparable in clinical effectiveness to conventional beta-agonist therapy, but was associated with fewer maternal cardiovascular side effects. We conclude that atosiban has clinical advantages over current tocolytic therapy.
Keyword Controlled trials
Birth-weight
Mortality
Morbidity
Q-Index Code C1
Q-Index Status Provisional Code
Institutional Status Non-UQ

Document type: Journal Article
Sub-type: Article (original research)
Collection: Faculty of Health and Behavioural Sciences -- Publications
 
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