A Randomised Controlled Trial Determining the Efficacy of Dinoprostone Vaginal Gel for Active Management of Prelabour Rupture of Membranes at Term

Abstract

Sudipta Jana1 , Abhijit Rakshit2 , Madhumita De3 , Arup Kumar Majhi4

BACKGROUND Dinoprostone gel shortens PROM–delivery interval, decreases maternal and neonatal morbidity, and thereby the hospital stay without increase in rate of caesarean section. For induction of labour, prostaglandin E2 cervical gel is quite effective and safe. We wanted to determine the safety and efficacy of dinoprostone vaginal gel in active management of PROM at term. METHODS This is a prospective randomised controlled trial study. We included 60 mothers, who attended labour room for induction and who fulfilled our inclusion and exclusion criteria, with their informed consent. 60 women were recruited for the trial who presented with PROM at term. Among them 30 mothers were recruited for dinoprostone gel induction group & 30 for expectant management group. All the patients were available for follow up and necessary data was collected from all the patients. Patients who delivered vaginally were followed up for 48 hrs. and those who delivered by LSCS were followed up for the next 7 days. RESULTS There is no statistical significance in Bishop Score at randomisation. Among 30 women selected for dinoprostone gel application, cervical ripening was noted among 83.3% of women. On the other hand only 26.7% of expectant group attended the desired score of Bishop score (>9). The difference is statistically significant (p value=.000). In this study, the average interval of induction to delivery in dinoprostone gel group is 15.17 hrs. and in expectant group it is 18.46 hrs. which is statistically lesser in dinoprostone group [asymp. sig. (2-tailed) value= 0.023 (Mann Whitney test)]. Almost 2/3rd of patients in dinoprostone gel group delivered vaginally and in expectant group 50% of the patients delivered vaginally. Rate of caesarean section was 20% and 30% in dinoprostone gel and expectant group respectively. It has been seen that post-partum fever and chorioamnionitis developed more in expectant group than in early induction group. However only chorioamnionitis is statistically significant. CONCLUSIONS Active management of PROM by early induction with dinoprostone vaginal gel is superior to expectant management, irrespective of cervical status.

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