COMPARISON OF EFFICACY AND SAFETY OF INTRACERVICAL FOLEYS CATHETER BALLOON WITH INTRACERVICAL PROSTAGLANDIN E2 GEL (DINOPROSTONE) FOR INDUCTION OF LABOUR

Introduction:Induction of labour is an intervention after 28 weeks of gestation, intended to artificially initiate uterine contractions resulting in the progressive effacement and dilatation of the cervix and ending in vaginal delivery. Sometimes because of medical or obstetric complications of pregnancy, cervical ripening and induction of labour is often required. Induction of labour is indicated when the benefits to either the mother or fetus outweigh those of continuing the pregnancy [1]. Aim Of The Study:To compare efficacy and safety of intracervical Foley?s balloon catheter with intracervical prostaglandin E2 gel (dinoprostone) for induction of labour. Objectives:To compare cervical ripening, induction-delivery interval, mode of delivery, maternal complications and fetal outcome by two methods. Materials And Methods:Prospective randomized controlled study. SAMPLE SIZE- Each group 50, determined by statistical analysis. Successful induction considered if the patient entered the active phase of labour/ bishop score 6. Result:In present study, both groups were comparable in age distribution. In both the groups, most of the study subjects were between the age group of 18-25 years (76% in pgE2 v/s 70% in Foley?s catheter group). Mean age in PGE2 gel group was 23.20?3.03 years while Mean age in Intra-Cervical Foley?s Catheter group was 23.92?3.11 years. Mean gestational age in PGE2 gel group was 39.12?1.33 weeks compared to 39.06?1.18 weeks in Intra-Cervical Foley?s Catheter group. At start of induction mean Bishop score was 1.62?1.10 in PGE2 gel group while it was 1.58?1.01 in Intra-Cervical Foley?s Catheter group. Deshmukh V et al also reported similar pre-induction mean Bishop score (1.48?0.67 in Foley?s Catheter group v/s 1.59?0.59 in pgE2 gel group). In our study, post-induction mean Bishop score at 6 hours was 6.56?2.13 in PGE2 gel group while it was 4.70?2.21 in Intra-Cervical Foley?s Catheter group. Mean change in Bishop score between 0 to 6 hours was significantly higher in pgE2 gel group (4.94?1.78) compare to Foley?s catheter group (3.12?1.78). The rate of LSCS in pgE2 gel group was 10% and 32% in Foley?s catheter group respectively. The induction delivery interval showed significantly higher time in intracervical Foley?s catheter groups. The mean induction delivery internal was 13.80?3.83 hrs in Foley?s group and 9.65?2.13 hrs in PGE2 group. In our study, common maternal complication observed were Intrapartum pyrexia (1 case in pgE2 gel group and 8 cases in Foley?s catheter group) and puerperal pyrexia (1 case in pgE2 gel group and 4 cases in Foley?s catheter group). 1 case of hyperstimulation was also seen in pgE2 gel group. Apart from that we have not seen any other complication in mothers. The present study shows that the fetal outcome results were also comparable in both the groups. Conclusion:The results of this trial tended to favor the prostaglandins use over Foley catheter use. The main advantage of the PGE2 gel is that early ripening of cervix, lesser caesarean rate and infection rate as compared to the Foley?s catheter while disadvantage is higher chances of uterine hypertonicity or tachysystole. but Foley?s catheter mimicked the physiology of the labour onset more closely, resulting in a less likelihood of hyperstimulation, fetal heart rate abnormalities and postpartum hemorrhage. Now, there is recent trend of reintroducing the mechanical methods like the Foley catheter, as there is an availability of sterile devices, controlling one of the principal contraindications- infection. Such mechanical methods are advantageous in terms of their reversibility and the reduced expenditure. But Foley?s catheter has been linked with a possibility of infections in some larger studies. Thus, tremendous attention should be drawn towards carrying out aseptic measures while it is being inserted, to avoid maternal and probable neonatal infections.