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.
Aims: To assess the efficacy and fetomaternal safety of atosiban among Indian pregnant women presenting with preterm labor. Study Design: Prospective, open-label, multicentric, non-comparative, phase-IV clinical study. Place and Duration of Study: Department of Obstetrics and Gynaecology at nine hospitals across India from October 2016 to December 2019. Methodology: A total of 212 pregnant women admitted with preterm labour between 24 and 36 weeks of gestation were administered intravenous atosiban up to 48 hours. Efficacy was defined as the successful delay of delivery without the need of an additional or alternative tocolytic agent for 72 hours. Safety was evaluated by recording the occurrence of adverse events in the mother, fetus and neonate. Results: Tocolytic efficacy of Atosiban was 84.88% at 48 hours and 74.15% at day 7 without additional tocolytic agent or retreatment after 48 hours. The mean number of days gained after the start of atosiban tocolysis were 29.15 ± 1.82 days with mean gestational age at delivery of 35.1 ± 3.33 weeks. Atosiban reduced the frequency of contractions from 4.3 ± 1.47 to 0.67 ± 1.13 contractions/30 min at 72 hours. The proportion of neonates with birth weights more than 2,500 gm was 41.67%. A total of 205 neonates out of 216 (94.95%) had APGAR score more than 7 after 5 minute. Atosiban successfully delayed the labour in 92.31% (n=13) of “Twin pregnancy” patients for 48 hours and beyond 7 days in 9 patients (69.2%). There were no serious adverse events reported. Conclusions: In patients with threatened preterm birth, 48 hour tocolysis with atosiban was found to be safe and effective in preventing imminent preterm birth even when it was a twin pregnancy or associated with co-morbidities. Atosiban showed favorable side effects profile and improved the perinatal outcomes. Clinical Trial Registry of India Number: CTRI/2017/03/008065;
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