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Peer-reviewedCC BY 4.0PLOS One

Cost-effectiveness of atosiban versus placebo for threatened preterm birth (APOSTEL 8 trial)

8 affiliations
  1. 1Department of Obstetrics and Gynaecology, Amsterdam UMC location University of Amsterdam, Amsterdam, Netherlands
  2. 2Amsterdam Reproduction and Development Research Institute, Amsterdam, Netherlands
  3. 3Department of Obstetrics and Gynaecology, Amsterdam UMC, Location Vrije Universiteit Amsterdam, Amsterdam, Netherlands
  4. 4Department of Obstetrics and Gynaecology, University Medical Center Utrecht, Utrecht University, Utrecht, Netherlands
  5. 5Department of Health Sciences, Faculty of Science, Vrije Universiteit Amsterdam, Amsterdam Public Health Research Institute, Amsterdam, Netherlands
  6. 6Department of Obstetrics and Gynaecology, Monash University, Clayton, Australia
  7. 7Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, United Kingdom
  8. 8Centre for Perinatal Research University of Nottingham, Queen’s Medical Centre, Nottingham, England

Abstract

Background: To assess the cost-effectiveness of treatment with atosiban compared to placebo for threatened preterm birth from 30+0 to 33+6 weeks of gestation. Methods: We performed an economic evaluation from a societal perspective alongside the multicentre randomised controlled APOSTEL 8 trial, including 755 participants with threatened preterm birth from 30+0 to 33+6 weeks of gestation who were randomised to atosiban or placebo, of whom 752 (884 infants) were included in the intention-to-treat analysis. Costs, collected between randomisation and three months corrected child age, were measured using a combination of hospital records and the self-reported iMTA Medical and Productivity Cost Questionnaires and estimated at infant level. The main outcome measure was cost-effectiveness expressed in terms of incremental cost per severe adverse neonatal outcome prevented. Multiple imputation by chained equations was used to handle missing data. Non-parametric bootstrapping was used to estimate statistical uncertainty surrounding incremental cost-effectiveness outcomes. Findings: The difference in mean costs between the atosiban group (€40,743.1) and the placebo group (€40,793.6) was not statistically significant (mean difference: -€50.5; 95% confidence interval (CI) −4037.6 to 3936.7). The incremental cost per severe adverse neonatal outcome prevented was dominant (-€5286.6), falling in the south-east quadrant of the cost-effectiveness plane, indicating cost-savings and reduced severe adverse neonatal outcomes by atosiban. However, the bootstrapped cost-effect pairs were distributed across all four quadrants of the cost-effectiveness plane, indicating high uncertainty surrounding cost-effectiveness estimates. The probability of cost-effectiveness of atosiban reached 50% at a willingness to pay threshold of €33,023.3 per severe adverse neonatal outcome prevented. Interpretation: This economic evaluation did not demonstrate that atosiban is a cost-effective treatment for threatened PTB from 30+0 to 33+6 weeks gestation. In addition to the absence of clinical benefit, our findings show no economic advantage, further discouraging its routine use at this gestational age. These results contribute to optimizing evidence-based management of threatened preterm birth.

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BibTeX
@article{windt2026costeffectiveness,
  title = {{Cost-effectiveness of atosiban versus placebo for threatened preterm birth (APOSTEL 8 trial)}},
  author = {Larissa van der Windt and Martijn Oudijk and Job Klumper and Tobias Nijman and Judith Bosmans and Ben Willem Mol and Joris van der Post and Carolien Roos and Stavros Petrou and Kate Walker},
  journal = {PLOS One},
  year = {2026},
  month = nov,
  doi = {10.1371/journal.pone.0347475},
  url = {https://doi.org/10.1371/journal.pone.0347475},
  note = {CC BY 4.0},
}
RIS
TY  - JOUR
TI  - Cost-effectiveness of atosiban versus placebo for threatened preterm birth (APOSTEL 8 trial)
AU  - Larissa van der Windt
AU  - Martijn Oudijk
AU  - Job Klumper
AU  - Tobias Nijman
AU  - Judith Bosmans
AU  - Ben Willem Mol
AU  - Joris van der Post
AU  - Carolien Roos
AU  - Stavros Petrou
AU  - Kate Walker
PY  - 2026
DA  - 2026/11/05
JO  - PLOS One
DO  - 10.1371/journal.pone.0347475
UR  - https://doi.org/10.1371/journal.pone.0347475
AB  - Background: To assess the cost-effectiveness of treatment with atosiban compared to placebo for threatened preterm birth from 30+0 to 33+6 weeks of gestation. Methods: We performed an economic evaluation from a societal perspective alongside the multicentre randomised controlled APOSTEL 8 trial, including 755 participants with threatened preterm birth from 30+0 to 33+6 weeks of gestation who were randomised to atosiban or placebo, of whom 752 (884 infants) were included in the intention-to-treat analysis. Costs, collected between randomisation and three months corrected child age, were measured using a combination of hospital records and the self-reported iMTA Medical and Productivity Cost Questionnaires and estimated at infant level. The main outcome measure was cost-effectiveness expressed in terms of incremental cost per severe adverse neonatal outcome prevented. Multiple imputation by chained equations was used to handle missing data. Non-parametric bootstrapping was used to estimate statistical uncertainty surrounding incremental cost-effectiveness outcomes. Findings: The difference in mean costs between the atosiban group (€40,743.1) and the placebo group (€40,793.6) was not statistically significant (mean difference: -€50.5; 95% confidence interval (CI) −4037.6 to 3936.7). The incremental cost per severe adverse neonatal outcome prevented was dominant (-€5286.6), falling in the south-east quadrant of the cost-effectiveness plane, indicating cost-savings and reduced severe adverse neonatal outcomes by atosiban. However, the bootstrapped cost-effect pairs were distributed across all four quadrants of the cost-effectiveness plane, indicating high uncertainty surrounding cost-effectiveness estimates. The probability of cost-effectiveness of atosiban reached 50% at a willingness to pay threshold of €33,023.3 per severe adverse neonatal outcome prevented. Interpretation: This economic evaluation did not demonstrate that atosiban is a cost-effective treatment for threatened PTB from 30+0 to 33+6 weeks gestation. In addition to the absence of clinical benefit, our findings show no economic advantage, further discouraging its routine use at this gestational age. These results contribute to optimizing evidence-based management of threatened preterm birth.
SN  - 1932-6203
ER  -