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Introduction: Isoxsuprine hydrochloride is a tocolytic agent approved in India for the management of women experiencing Preterm labor (PTL) and has been in wide use for over six decades. Aim & Objectives This study assessed the effectiveness and safety of Isoxsuprine, a tocolytic agent, in Indian women experiencing PTL. Methods Pregnant women (n=170) diagnosed with PTL were treated with an intravenous infusion of Isoxsuprine until uterine quiescence was achieved. This was followed by oral Isoxsuprine therapy (40 mg twice daily). The primary endpoint was the number and percentage of women achieving successful tocolysis at 24 and 48 hours after the start of therapy. Adverse drug reactions (ADRs) were monitored from the beginning until period of 5 half-lives of the drug after the last dose. Results Successful tocolysis was achieved in 166 (97.6%) women at 24 hours and in 165 (97.1%) women at 48 hours. Adverse drug reactions (ADRs) occurred in 10 (5.9%) women; four serious ADRs (fetal distress syndrome [n=2], stillbirths [n=2]) which were considered unlikely related to study drug. No clinically significant abnormalities like tachycardia or hypotension were reported. Telephonic follow-up data from 146 (85.9%) women showed all delivered healthy babies (no congenital abnormalities) with mean (? standard deviation) birth weight of 2.7?0.43 kgs. Conclusion Isoxsuprine was effective and well-tolerated in the treatment of PTL, with favourable maternal and perinatal outcomes. This study provides real-world evidence for the effectiveness and safety of Isoxsuprine intravenous infusion followed by oral treatment in the treatment of preterm labor in Indian women. Conflict of Interest: There is no conflict of interest declared by the authors. Source of Funding: The research is funded by Abbott India Ltd.