Aims and Objectives: To study pregnancy outcome in term patients with premature rupture of membranes (PROM) in whom labour was induced with oral misoprostol.

Study Design: The study was a randomized prospective study of 150 cases of pregnant women with singleton pregnancies at and beyond 37 weeks of gestation with induction of laborwith oral misoprostol in PROM. Informed consent was taken.

Materials and Methods: The study was carried out in the department of Obstetrics and Gynaecologyat a Tertiary care health institute. The study was a prospective study of 150 cases of pregnant women with singleton pregnancies with induction of labor with oral misoprostol in PROM. 150 cases of pregnant women with singleton pregnancies with PROM for induction of labor with oral misoprostol at and beyond 37 weeks of gestation were approached for the study. Study was approved by the ethics committee of the hospital. Informed consent was taken. The outcome was decided into primary and secondary outcome Primary outcome was measured as PROM-induction interval, PROM-delivery interval and induction to delivery interval. Secondary outcome was measured in terms of mode of delivery, number of doses of drug used, indication of cesarean section, maternal and neonatal complications, adverse effects of drugs like fever, diarrhoea, nausea and others, APGAR score of the neonate at 5 minute, NICU admission and neonatal infection.

Results: Out of the studied patients 8% were in between age group of 18-20 years, 60%were between 21-25 years, 28% were in between 26-30 years and 4% were more than30 years. Booked cases were 84% and unbooked cases were 16%. Out of these 60%cases were prima and 40% cases were multigravida. Gestational age wise 52% were in between gestational age of 37-39 weeks,28% were in between 39-40 weeks and 20%cases were having a gestational age of more than 40%. Out of these 1,2,3 and 4 doses of misoprostol were required in 20%,48%,20% and 12% respectively. Distribution of cases depending upon the doses of misoprostol required and mode of delivery and needfor instrumentation revealed that out of 102 cases requiring 1 or 2 doses of misoprostol only 2 patients required instrumentation while out of 39 cases requiring 3 or 4 doses of misoprostol 10 cases needed instrumentation. This was statistically significant. Analysis of misoprost ol doses required in relation with maternal complications revealed that Nausea, vomitings, diarrhea and fever was not statistically significant in relation to the number of misoprostol given while incidence of Post partum hemorrhage was statistically significant in those cases receiving more doses of misoprosolt. Analysis of distribution of cases according to PROM-induction interval revealed that 64% cases took 0-6 hours,24% cases were in between 6-12 hours and 12 % cases required more than 12 hours. The distribution of cases from PROM-Delivery revealed that time required was 0-12hours,12-24 hours and more than 24 hours in 60%,30% and 10% respectively while the time required from induction to delivery was 0-12 hours,12-24 hours and more than 24 hours in 68%,28% and 4% respectively. Amongst the cases studied 69.33% delivered vaginally while instrumentation and LSCS was required in 22.66% and 5.33%respectively. The analysis of distribution of cases of PROM delivery interval in relation to mode of delivery revealed that in cases requiring more than 24 hours from PROM to delivery majority (80%) were those who delivered vaginally. Most common indication of LSCS amongst studied cases was Fetal distress (61.76%). Most common maternal complications were Nausea and vomitings (12%) followed by Fever (6%), Post partumhemorrhage (5.33%) and diarrhoea (2.66%). The duration of PROM delivery and maternal complications were studied where it was found that incidence of PPH was significantly higher (P value < 0.01) if this duration was more than 24 hours. The analysis of delivered babies showed that 8% babies had weight of 2kg or less while thebabies weighing 2.1-2.5 kg and more than 2.5 kg were 52% and 40% respectively. Mostcommon neonatal complications observed were need of antibiotics (32.66%) followed by meconium stained amnioticc fluid (19.33%), APGAR score of less than 7 at 5minutes(6%), NICU admissions (6%), Hyperbillirubinemia (4.66%), Neonatalencepalopathy (3.33%) and respiratory distress syndrome(2%). And finally the analysis of cases on the basis of PROM-Delivery Interval in relation with Neonatal complications revealed that the Meconium stained amniotic fluid (23 cases) was most complication if this duration was less than 12 hrs while in cases where this duration was 12-24 hours and more than 24 hours the most common complications seen were need for prophylactic antibiotics (24 cases) and sepsis (11 cases) respectively.

Conclusion: The incidence of Maternal and Neonatal complications increase as the duration of PROM increases in pregnancies with full term gestation in whom labour was induced by misoprostol.

Keywords: Premature Rupture of membranes, Misoprostol, Primary and secondary Outcome.