OBJECTIVES: To study the safety and efficacy of oral @entity3927 in pre-induction cervical ripening and induction of labour in prolonged pregnancy. METHODS: This is a single blind randomized control trial. 100 @entity1 with prolonged pregnancy beyond 40  weeks and Bishop score <6 were recruited, and randomly allocated into two groups. @entity1 who received Tab. @entity3927 200  mg orally were assigned in Study Group (n  =  50) and who received placebo orally were assigned in Control Group (n  =  50) At the end of 24  h, change in the Bishop's score was assessed and Tab. @entity396 25   g was administered intravaginally every 4  h, maximum 6 doses for induction/augmentation of labour. Analysis regarding safety and efficacy of the drug was done with regards to maternal and perinatal outcome. RESULTS: Among 100 subjects, 50 received @entity3927 and 50 received placebo. Mean induction to delivery interval was 1,907      368.4  min for Study Group versus 2,079      231.6  min for Control Group. The improvement in mean Bishop score was 5.0408      1.90 for Study Group compared with 3.26      1.15 was for Control Group after 24  h. Mean dose of @entity396 in Study Group was 40      27.2, while the same in Control Group was 52      19.46. Eight (16  %) @entity1 in Study Group and two (4  %) @entity1 in Control Group delivered vaginally within 24  h without any need of augmentation. There were 6 (12  %) cesareans and 2 (4  %) instrumental deliveries in Study Group and 8 (16  %) cesareans and 5 (10  %) instrumental deliveries in the Control Group. There was no statistically significant difference in perinatal outcomes between two groups. CONCLUSIONS: @entity3927 had a modest effect on cervical ripening when given 24  h prior to labour induction and appearing to reduce need for @entity396 compared with placebo.

Safety and Efficacy of Oral XXXX in Pre-induction Cervical Ripening and Induction of Labour in Prolonged Pregnancy.

@entity1 :: ('9606', 'Species') :: ['women', 'Women'] @entity3927 :: ('MESH:D015735', 'Chemical') :: ['Mifepristone', 'mifepristone'] @entity396 :: ('MESH:D016595', 'Chemical') :: ['Misoprostol', 'misoprostol']
@entity3927 :: (MESH:D015735,Chemical) :: ['Mifepristone']
