Abstract

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;