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  • Atosiban for Preterm...

Atosiban for Preterm Birth: Prolongs labour but not Neonatal outcomes, finds study

Written By : Dr. Shravani Dali |Medically Reviewed By : Dr. Kamal Kant Kohli Published On 2025-03-24T22:00:11+05:30  |  Updated On 25 March 2025 11:28 AM IST
Atosiban for Preterm Birth: Prolongs labour but not Neonatal outcomes, finds study
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Researchers have found that while the tocolytic drug atosiban prolonged labor in cases of threatened preterm birth beyond 30 weeks, it did not improve neonatal outcomes compared to a placebo. They questioned its effectiveness as a treatment, as reported in The Lancet.

Tocolytics are recommended in international guidelines as a treatment for threatened preterm birth. Atosiban, an oxytocin receptor antagonist, is a registered tocolytic drug specifically indicated for the treatment of threatened preterm birth. Although tocolytics have been shown to delay birth, benefits on neonatal outcomes have not been demonstrated. In the APOSTEL 8 trial we aimed to assess the superiority of tocolysis with atosiban compared with placebo in threatened preterm birth from 30 weeks and 0 days (30+0 weeks) to 33+6 weeks of gestation in improving neonatal morbidity and mortality.

This was an international, multicentre, randomised, double-blind, superiority trial conducted in 26 hospitals in the Netherlands, England, and Ireland. After written informed consent, women aged 18 years or older with a singleton or twin pregnancy with threatened preterm birth from 30+0 to 33+6 weeks of gestation were randomly assigned (stratified by centre, 1:1 ratio) to intravenous atosiban or placebo.

The primary outcome was a composite of perinatal mortality (stillbirth and death until 28 days postpartum) and six severe neonatal morbidities. Analysis was by intention-to-treat. Treatment effect was estimated as relative risk (RR) with 95% CI. This trial was prospectively registered at EudraCT (2017-001007-72) and the Netherlands Trial Registry (NL-OMON54673), and is complete. Findings: Between Dec 4, 2017, and July 24, 2023, a total of 755 participants were randomly assigned, of whom 752 were included in the intention-to-treat analysis (atosiban n=375, placebo n=377).

The primary outcome occurred in 37 (8%) of 449 infants in the atosiban group and 40 (9%) of 435 in the placebo group (RR 0·90 [95% CI 0·58–1·40]). There were three (0·7%) and four (0·9%) infants who died, respectively (RR 0·73 [0·16–3·23]); all deaths were deemed unlikely to be related to the study drug. Maternal adverse events did not differ between groups, and there were no maternal deaths. They did not demonstrate superiority of atosiban over placebo in improving neonatal outcomes as treatment for threatened preterm birth from 30+0 to 33+6 weeks of gestation. As the primary goal of tocolysis should be improvement of neonatal outcomes, our outcomes question the standardised use of atosiban as treatment for threatened preterm birth from 30+0 to 33+6 weeks of gestation. Our findings should reduce practice variation across countries and will contribute to evidence-based treatment for patients with threatened preterm birth.

Reference:

Atosiban versus placebo for threatened preterm birth (APOSTEL 8): a multicentre, randomised controlled trial van der Windt, Larissa ISchaaf, Jelle M et al. The Lancet, Volume 405, Issue 10483, 1004 - 1013

AtosibanPretermBirthProlongslabourNeonataloutcomesfinds studyThe Lancet
Source : The Lancet
Dr. Shravani Dali
Dr. Shravani Dali

    Dr. Shravani Dali has completed her BDS from Pravara institute of medical sciences, loni. Following which she extensively worked in the healthcare sector for 2+ years. She has been actively involved in writing blogs in field of health and wellness. Currently she is pursuing her Masters of public health-health administration from Tata institute of social sciences. She can be contacted at editorial@medicaldialogues.in.

    Dr. Kamal Kant Kohli
    Dr. Kamal Kant Kohli

    Dr Kamal Kant Kohli-MBBS, DTCD- a chest specialist with more than 30 years of practice and a flair for writing clinical articles, Dr Kamal Kant Kohli joined Medical Dialogues as a Chief Editor of Medical News. Besides writing articles, as an editor, he proofreads and verifies all the medical content published on Medical Dialogues including those coming from journals, studies,medical conferences,guidelines etc. Email: drkohli@medicaldialogues.in. Contact no. 011-43720751

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