Study to evaluate the efficacy and safety of Atosiban in preterm labour in North Indian population

Abstract

Background: Preterm birth occurs in 5-10% of all pregnancies, leading to an estimated 13 million preterm births worldwide. The goal of managing spontaneous preterm labour is to minimise perinatal morbidity and mortality while preserving maternal health. Improved outcomes are associated with administration of a full course of corticosteroids to aid fetal pulmonary maturation and timely in utero transfer to a specialist unit where the neonate can receive optimal care.Methods: A prospective, open label, non-comparative study was conducted at Ganesh Shankar vidhyarthi memorial Medical College, Kanpur in the department of obstetrics and gynaecology over a period of one year. After informed consent and ethical clearance from institutional ethics committee, Kanpur, total 72 pregnant women were recruited for this study. Eligible patients received treatment with atosiban as intravenous (I.V.) infusion for 48 hrs in three successive stages. Patients were assessed at 24 hrs, 48 hrs and 72 hrs after treatment, followed by an end of study assessment at discharge (or on the 7th day, whichever was earlier). Results: Mean age of women was 24±3.6 years and gestational age was 32 ± 2.14 weeks. In this study atosiban was successful in delaying preterm labour for ≥ 48 hours in 23.50%, ≥ 72 hours in 70.50% while 5.80% women remained undelivered for ≥ 7 days who did not require an alternate tocolytic agent or retreatment which is similar to the study of Dewan et al. where for ≥ 48 hours in 84.88% while 74.15% for ≥ 7 days, the effect of atosiban treatment on fetal health was analysed in terms of APGAR score, in which out of total 72 preterm new borns, only 12 (16.66%) had APGAR score ≤ 7 while 60 (83.33%) had APGAR score of > 7.Conclusion: The present study shows that atosiban is a safe and effective drug for the treatment of preterm labour. There were no serious maternal or fetal side effects.