None listed
Conditions
Brief summary
Misoprostol and Dinoprostone are both medications used to ripen a woman's cervix in preparation for labour. In a phase III trial by Wing et al misoprostol vaginal insert, when compared to dinoprostone vaginal insert, was thought to reduce the time from insert to vaginal delivery and decrease the number of women needing further intervention by oxytocin for induction of labour by 26% without an increase in the complications of caesarean section or neonatal morbidity. Misoprostol was found to increase the rate of tachysystole (too frequent uterine contractions) to 13% compared with 4% for dinoprostone. Wing et al used both primiparous women and multiparous women in their study. We hypothesize that by using misoprostol in primiparous women only we may still be able to achieve the significant reduction in need for other interventions for induction of labour but without the significant increase in rates of uterine tachysystole. Women admitted to the study will have either the misoprostol or dinoprostone inserted for cervical ripening and data collected on whether or not they then needed to have a cervical ripening balloon for further ripening, whether they needed oxytocin for induction of labour, whether they had too many contractions that required intervention to control, what their mode of delivery was, what the time interval between when the pessary was inserted and when they delivered and whether or not there were any neonatal complications.
Interventions
Misoprostol 200microgram slow release pessary is placed per vagina on admission to hospital. This occurs 48 hours prior to planned induction of labour. The cervix is reassessed 24 hours post administration and misoprostol pessary removed unless indicated earlier. (indications for early removal include active labour, ruptured membranes, abnormal fetal cardiotocography, uterine hyperstimulation)
Sponsors
John Hunter Hospital
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1) Pregnant women between 37+0 and 41+4 weeks gestation 2) Having first baby 3) Induction of labour deemed medically indicated 4) Bishops score less than or equal to 4 5) age >=18 6) BMI <50 at booking visit
Exclusion criteria
1) Active labour 2) Ruptured membranes 3) Non-cephalic presentation 4) Previous caesarean section or other uterine surgery 5) Unexplained vaginal bleeding >24 weeks gestation 6) Suspected or known chorioamnionitis 7) Suspected or known fetal compromise (abnormal antenatal fetal heart rate pattern, ultrasound showing fetal growth <10th centile, oligohydramnios, polyhydramnios, abnormal dopplers) 8) Unable to read or speak English without the aid of an interpreter
Outcome results
None listed