Efficacy and Safety of Atosiban in Prevention of Preterm Labor: Experience from Bangladesh

Abstract

Background:

Preterm labor remains a leading cause of neonatal morbidity and mortality, particularly in low- and middle-income countries such as Bangladesh. Timely and safe tocolytic therapy is essential to delay delivery and improve perinatal outcomes. Atosiban, a selective oxytocin receptor antagonist, offers a targeted mechanism of action with a favorable safety profile; however, evidence from real-world clinical settings in South Asia remains limited.

Aim:

To evaluate the effectiveness and safety of atosiban in the prevention of threatened preterm labor in a tertiary care hospital setting in Bangladesh.

Methods:

This Phase IV, retrospective, observational cohort study included women presenting with threatened preterm labor between >28 and <34 weeks of gestation who were treated with atosiban from January to December 2023. Atosiban was administered as an intravenous bolus followed by continuous infusion for up to 48 hours. The primary endpoint was the proportion of women maintaining a viable pregnancy for at least 4–6 weeks after treatment. Secondary outcomes included requirement for additional management, maternal and neonatal adverse events, mode of delivery, and neonatal outcome. Data were analyzed using descriptive statistics, and exploratory subgroup analyses were performed.

Findings:

A total of 48 women were enrolled in the study. The mean maternal age was 29.4 ± 4.6 years. Pregnancy prolongation for at least four weeks was achieved in 77.1% (37/48) of patients. Exploratory analyses demonstrated numerically higher pregnancy prolongation rates among women aged <30 years, those without a prior history of preterm labor, and those not requiring additional management. Maternal adverse events were reported in 16.7% of patients, with no serious adverse events observed. Normal vaginal delivery occurred in 60.4% of cases. Neonatal survival was 100%.

Conclusion:

Atosiban demonstrated effective pregnancy prolongation with a favorable maternal and neonatal safety profile in women with threatened preterm labour. These findings support its use as a pragmatic tocolytic option in routine clinical practice within resource-constrained South Asian settings.