Clinical safety and efficacy of atosiban brief duration 14-hour treatment regimen in delaying preterm labor

Authors

  • Bhupesh Dewan Medical Services, Zuventus Healthcare Limited, Mumbai, Maharashtra, India
  • Siddheshwar Shinde Medical Services, Zuventus Healthcare Limited, Mumbai, Maharashtra, India

DOI:

https://doi.org/10.18203/2320-1770.ijrcog20231569

Keywords:

Preterm labor, Brief duration regimen, Atosiban, Tocolysis, Efficacy, Patient convenience

Abstract

Background: For preventing preterm labor, the recommended duration of atosiban infusion is 48 hours and the patient has to be hospitalized during the course of treatment. The treatment consists of administering one vial of 0.9 ml as a bolus and then an infusion at a rate of 300 mcg/min for 3 hours followed by 100 mcg/min for the next 45 hours, utilizing nine vials of 5 ml. The objective of the study was to evaluate an alternative brief duration (14-hour) of atosiban treatment involving a bolus dose of 0.9 ml followed by an infusion of 300 mcg/min for 2 hours and 100 mcg/min for the next 12 hours utilizing 3 vials of 5 ml. The advantage being that the treatment could be completed in an outpatient setup and be convenient for the patient as well as for the healthcare staff. This would also reduce the overall cost of the treatment. This prospective single-center study was conducted to evaluate the efficacy and safety of an atosiban brief duration (14-hour) treatment regimen to prevent preterm labor.

Methods: A total of 50 patients with symptoms of preterm labor were enrolled in the study. The efficacy of tocolysis was determined by the percentage of patients who remained undelivered up to 48 hours after atosiban therapy initiation and the follow-up of the patients was done up to delivery. Safety was assessed in terms of the number of maternal and fetal adverse events reported.

Results: The mean gestational age at the enrolment was 32.1±2.6 weeks and the delivery were delayed by a mean of 18.13±17.97 days (range 1-62 days). Thirty-five (70%) patients remained undelivered at 48 hours and 29 (58%) at 7 days. No maternal or fetal adverse events were reported during the study.

Conclusions: A favourable safety and efficacy profile of a brief duration atosiban regimen was observed resulting in ease of administration and a shorter stay in the healthcare facility providing convenience to both patient and hospital staff. The overall cost of the therapy was also reduced. Further clinical trials with larger sample size are required to confirm the findings.

References

UNICEF. Fact sheet: Key data. Available at: https://www.unicef.org/india/key-data. Accessed on 5 April 2023.

Chawanpaiboon S, Vogel JP, Moller AB, Lumbiganon P, Petzold M, Hogan D, et al. Global, regional, and national estimates of levels of preterm birth in 2014: A systematic review and modelling analysis. Lancet Glob Health. 2019;7(1):37-46.

Dandona R, Kumar GA, Henry NJ, Joshua V, Ramji S, Gupta SS, et al. Subnational mapping of under-5 and neonatal mortality trends in India: The Global Burden of Disease Study 2000-17. Lancet. 2020;395(10237):1640-58.

Lamont CD, Jørgensen JS, Lamont RF. The safety of tocolytics used for the inhibition of preterm labour. Expert Opin Drug Saf. 2016;15(9):1163-73.

Central Drugs Standard Control Organization Atosiban. New Drugs Approved by Central Drugs Standard Control Organization, India. Available at: https://cdscoonline.gov.in/CDSCO/Drugs. Assessed on 5 April 2023.

Yu Y, Yang Z, Wu L, Zhu Y, Guo F. Effectiveness and safety of atosiban versus conventional treatment in the management of preterm labor. Taiwan J Obstet Gynecol. 2020;59(5):682-5.

Saleh SS, Al-Ramahi MQ, Al Kazaleh FA. Atosiban and nifedipine in the suppression of pre-term labour: a comparative study. J Obstet Gynaecol. 2013;33(1):43-5.

Dewan B, Shah D. The clinical experience of atosiban in preterm labour. J Adv Med Med Res. 2016;13(7):1-9.

Baev OR, Vasilchenko ON, Karapetyan AO, Tetruashvili NK, Khodzhaeva ZS. A comparison of tocolysis with nifedipine or atosiban in preterm labor. Obstetr Gynecol. 2018;5:50-6.

Wex J, Abou-Setta AM, Clerici G, Di Renzo GC. Atosiban versus betamimetics in the treatment of preterm labour in Italy: clinical and economic importance of side-effects. Eur J Obstet Gynecol Reprod Biol. 2011;157(2):128-35.

Wex J, Connolly M, Rath W. Atosiban versus betamimetics in the treatment of preterm labour in Germany: an economic evaluation. BMC Pregn Childbirth. 2009;9:23.

Sebastian E, Bykersma C, Eggleston A, Eddy KE, Chim ST, Zahroh RI, et al. Cost-effectiveness of antenatal corticosteroids and tocolytic agents in the management of preterm birth: a systematic review. E Clinic Med. 2022;49:101496.

Hrubý K. Comparison of the cost of treatment of premature labor with atosiban or beta-sympathomimetics from the perspective of the health care payer--a pharmacoeconomic model. Ceska Gynekol. 2004;69(2):96-105.

Fullerton GM, Black M, Shetty A, Bhattacharya S. Atosiban in the management of preterm labour. Clinical Medicine Insights: Women Health. 2011;4:9-16.

Goodwin TM, Millar L, North L, Abrams LS, Weglein RC, Holland ML. The pharmacokinetics of the oxytocin antagonist atosiban in pregnant women with preterm uterine contractions. Am J Obstet Gynecol. 1995;173:913-7.

Goodwin TM, Valenzuela G, Silver H, Hayashi R, Creasy GW, Lane R. Treatment of preterm labor with the oxytocin antagonist atosiban. Am J Perinatol. 1996;13(3):143-6.

Goodwin TM, Valenzuela GJ, Silver H, Creasy G. Dose ranging study of the oxytocin antagonist atosiban in the treatment of preterm labor. Atosiban Study Group. Obstet Gynecol. 1996;88(3):331-6.

Moutquin JM, Sherman D, Cohen H, Mohide PT, Hochner-Celnikier D, Fejgin M, et al. Double-blind, randomized, controlled trial of atosiban and ritodrine in the treatment of preterm labor: a multicenter effectiveness and safety study. Am J Obstet Gynecol. 2000;182(5):1191-9.

Lin CH, Lin SY, Shyu MK, Chen SU, Lee CN. Randomized trial of oxytocin antagonist atosiban versus beta-adrenergic agonists in the treatment of spontaneous preterm labor in Taiwanese women. J Formos Med Assoc. 2009;108(6):493-501.

Ya-Juan X, Li-Min R, Xiao-Hua L, Shan-Shan Z, Zhong-Yuan Z, Ying-Ying Z, et al. Clinical efficacy of atosiban treatment in late abortion and preterm labour of twin pregnancy. Int J Clin Exp Med. 2016;9(2):3946-52.

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Published

2023-05-26

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Original Research Articles