Abstract: Background: The idea of this study was to evaluate the efficacy and safety of different routes of administration of misoprostol - 50µg oral, 25µg vaginal and 50µg sublingual for induction of labour in women with premature rupture of membranes after 34 weeks of gestation.
Design: Randomized controlled trial.
Sample: A total of 252 women with premature rupture of membranes after 34 weeks of gestation with indications of induction of labour.
Methods: Study was conducted from 01/02/2022 to 31/11/2022, Women admitted to ward with premature rupture of membranes (PROM) after 34 weeks of gestation and requiring induction of labour were randomized into three groups. A total of 252 women participated in the study and were assigned to three groups to receive either 50µg oral misoprostol (n=82) or 25µg vaginal misoprostol (n=85) or 50µg sublingual misoprostol (n=85). The doses were repeated 4 hourly till active labour was established or up to a maximum of 4 doses.
Major outcomes: 1.Induction to active labour 2.induction to delivery intervals 3.Delivery modes and 4.fetal outcomes were noted.
Results: The mean induction to active labour interval was not significantly different in the three groups (oral vs vaginal vs sublingual- 7.54±4.8 vs 7.77±4.1 h vs 7.68±5.1 h; p=0.92). There was no significant difference in the induction to delivery time interval among the three misoprostol groups (oral vs vaginal vs sublingual – 10.7± 5.5 h vs 11.2±5.0 h vs 11.2±6.4 h; p= 0.88). Spontaneous vaginal delivery rate, instrumental delivery rate and lower segment caesarean section rates were comparable among the three groups. The spontaneous vaginal delivery is more in vaginal group and least in the sublingual group. The oral group is almost equal to the sublingual group in spontaneous delivery. The number of neonates with APGAR score <7 (low APGAR) at 1 minute of birth was highest in sublingual group and lowest in vaginal group which was statistically significant (oral vs vaginal vs sublingual, 16.8% vs 9.4% vs 20%; p= 0. 04). APGAR score <7 at 5 minutes was not significantly different among the three groups (oral vs vaginal vs sublingual, 6.02% vs 3.5% vs 7.05%; p=0.2). This implies that the need for immediate resuscitation was more in the sublingual group. Neonatal intensive care admission was least in the vaginal group although the difference was not statistically significant.
Conclusion: 50µg oral misoprostol, 25µg vaginal misoprostol or 50µg sublingual misoprostol for induction of labour after 34 weeks of gestation have equal efficacy for induction of labour in women with spontaneous vaginal delivery is highest in vaginal route. The spontaneous vaginal delivery is more in vaginal route. The sublingual route having slightly higher incidence of low APGAR scores at one minute for the neonate.
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