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Am J Perinatol 2021; 38(03): 291-295
DOI: 10.1055/s-0039-1696720
Original Article

Effectiveness and Safety of Isoxsuprine Hydrochloride as Tocolytic Agent in Arresting Active/Threatened Preterm Labor and Its Role in Maintenance Tocolysis: A Prospective, Open-Label Study

Purushottam B. Jaju
1   Department of Obstetrics and Gynecology, B.M. Patil Medical College Hospital and Research Centre, Vijayapur, Karnataka, India
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Funding This investigator-initiated study was funded by Abbott India Limited.
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Abstract

Objective The aim of the study is to obtain insights on the short and long-term safety and effectiveness of isoxsuprine hydrochloride as a tocolytic agent in the management of PTL.

Study Design In this prospective, single-center, noncomparative study, patients (with preterm labor at gestational age of 24–37 weeks) were administered intravenous (IV) infusion of 40-mg isoxsuprine hydrochloride until uterine quiescence, followed by intramuscular (IM) injection of isoxsuprine hydrochloride 10 mg/4-hourly for first 24 hours and maintained with retard 40-mg sustained release capsule (two times a day) till the time of delivery or 37 completed weeks of pregnancy.

Results All patients (n = 50) achieved successful tocolysis in 24 hours and 48 hours postadministration of isoxsuprine hydrochloride (IV/IM/oral). Mean (±SD) gestation age at the time of delivery was 39.8 ± 2.1 weeks, with latency period of 58.5 ± 18.7 days. Pregnancy outcomes were normal in all the patients and no congenital anomaly/fetal infection was reported. Mean (±SD) fetal birth weight was 2.7 ± 0.3 kg; mean (±SD) Apgar score at 1 and 5 minutes were 7.5 ± 0.6 and 9.2 ± 0.4, respectively. Maternal tachycardia and vomiting (8.0% each) were the commonly reported adverse drug reactions, which were resolved with dose adjustment.

Conclusion Isoxsuprine was found to be an effective and well-tolerated tocolytic agent in arresting PTL, in turn resulting in the overall improvement in maternal and perinatal outcomes.

Keywords

isoxsuprine - latency period - preterm labor - pregnancy prolongation - tocolytics

Note

This data was presented (oral presentation) at the 26th World Congress on Controversies in Obstetrics, Gynecology & Infertility (COGI), London, UK—November 23 to 25, 2018




Publication History

Received: 11 June 2019

Accepted: 01 August 2019

Article published online:
24 September 2019

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